CELEX: 52013PC0260
Language: en
Date: 2013-05-06
Title: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health

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		52013PC0260
		
			Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health /* COM/2013/0260 final - 2013/0136 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
1.           JUSTIFICATION AND OBJECTIVE
Animal health is a concern for all European
citizens. This concern stems from the public health, food safety and food
security aspects, which are related to animal health but also from the economic
costs that animal disease outbreaks can trigger and the animal welfare
considerations, including the implications of disease control measures on
animal welfare. 
At the same time, this proposal reflects the
priorities of Smart Regulation[1] by aiming to simplify the
existing legal framework while reflecting stakeholders' expectations in
reducing administrative burdens. 
And finally, it reflects Commission priorities
such as the smart growth objective of the Europe 2020 strategy[2]
by helping the sector to become more resilient due to active prevention
measures and more flexible risk management.
Problem analysis
The current EU animal health legislative
framework involves almost 50 basic directives and regulations and some 400
pieces of secondary legislation, some of them adopted as early as 1964. 
The Commission launched an external evaluation
in 2004 to thoroughly review the outcomes of EU action of animal health,
leading to a new Animal Health Strategy in 2007. A combination of circumstances
made it imperative to re-evaluate our policy: 
        The main elements of the existing policy were drawn up
largely between 1988 and 1995 when we were still a Community of twelve Member
States;
        New challenges have emerged. Diseases which were unknown a
decade ago have appeared, while others, such as foot and mouth disease,
bluetongue and avian flu, have recently presented new challenges, reminding us
that they remain very serious risks;
        Trading conditions have also changed radically with the
volume of trade in animals and animal products increasing greatly, both within
the EU and with third countries; and 
        Science, technology and our institutional 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 Community
Animal Health Policy (CAHP)
–              
The lack of an overall strategy
–              
An insufficient focus on disease prevention,
with a particular focus on the need for increased biosecurity.
Others were related to specific problems with
the functioning of existing legislation, particularly: 
–              
Issues related to intra-Union trade in live
animals.
Both general and specific problems are either
rectified in this law, or will be rectified in its delegated and implementing
acts. 
Objectives of the
proposal
The Animal Health Law is
the legal framework to support the Animal Health Strategy for the EU, published
in 2007. The general objectives as outlined in the Strategy are: 
        to ensure a high level of public health
and food safety by minimising the incidence of biological and chemical risks to
humans;
        to promote animal health by
preventing/reducing the incidence of animal diseases, and in this way to
support farming and the rural economy;
        to improve economic growth/cohesion/competitiveness
assuring free circulation of goods and proportionate animal movements;
        to promote farming practices and animal
welfare which prevent animal health related threats and minimise environmental
impacts in support of the EU Sustainable Development Strategy. 
The specific objectives of
this Animal Health Law are:
        to establish a single, simplified,
transparent and clear regulatory framework that sets out systematically the
objectives, scope and principles of regulatory intervention; based on good
governance and compliant with international (e.g. OIE) standards; focusing on
long-term preventative measures and working together with all relevant
stakeholders;
        to introduce overarching general
principles allowing a simplified legal framework in order to be prepared for
the new challenges, i.e. to enable quick reaction in case of emerging diseases;
whilst ensuring the same quality of reaction as provided for in current
legislation;
        to ensure consistency amongst the
horizontal principles of the legislation in the field of animal health, animal
welfare and food safety policies as well as broader EU policies on climate
change, common agricultural policy and sustainability;
        to reduce the impact of animal diseases
on animal and public health, animal welfare, economy and society as far as
possible by enhancing disease awareness, preparedness, surveillance 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 health 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
distribution of roles and responsibilities between competent authorities, EU
institutions, the farming sector, animal owners and others;
        to introduce disease categorization as
the basis for EU intervention;
        to provide for effective mechanisms for
a rapid response to disease events, including new challenges, such as emerging
diseases;
        to ensure effective emergency
preparedness and early response to animal diseases and zoonoses, including use
of vaccines as appropriate;
        to introduce simplified procedures,
wherever possible for technical and other reasons, taking into account the
specificity of small farmers and micro businesses and releasing unjustified
administrative burdens and costs, wherever possible;
        to ensure that the new legal framework
provides enough flexibility to adapt smoothly to future scientific and
technological developments;
        to reduce the risk of trade disruption
by seeking an appropriate level of convergence with relevant international
standards, while ensuring a firm commitment to high standards of animal health.

2.           LEGAL CONTEXT
Legal Basis
Articles 43, 114 and 168 of the Treaty on the
Functioning of the European Union (TFEU) provide the legal basis for the EU
legislative measures on animal health, as they are an essential part of EU
agricultural, public health and consumer protection, trade and single market
policy. 
–              
Article 43 provides the basis for the EU
legislative measures on the Common Agricultural Policy. This article also
became the basis for veterinary legislation as the CAHP is considered from a
legal perspective to be part of the Common Agricultural Policy, so adopting the
same legislative and administrative procedures. 
–              
Article 114 provides the legal basis for the
establishment and functioning of the internal market and the approximation of
provisions laid down by the law, regulation or administrative actions in this
respect. 
–              
Article 168 on health protection refers to the
protection of human health from all causes that may damage it, including those
related to animal health. Veterinary measures directly aimed at protecting
public health were also
adopted under the co-decision procedure as a result of this
article.". 
Consistency with other Union policies
This set of animal health legislation interacts
with the legal framework on animal welfare, food safety, public health, animal
nutrition, veterinary medicinal products, environmental protection, official
controls, the Common Fisheries Policy (CFP) and the Common Agricultural Policy
(CAP). 
Relationship to other proposals in the
package
The proposal is part of a package of four
reviews relating to animal health, health of plants, quality of plant
reproductive material and official controls of plants, animals, food and feed. 
The revision of the
official controls regulation enables official controls to be more consistently
applied for the purposes of protection of animal health and links more
coherently with animal health regulation. 
3.           SUBSIDIARITY
AND PROPORTIONALITY
Subsidiarity
Good animal health generates not only private
benefits but is a public good with wider societal benefits. The transmissible
nature of many animal diseases means that a common approach, rather than a
series of individual actions, will have the greatest overall benefits. 
The value of the harmonised EU approach is
widely accepted and has helped to reduce the administrative burden for
operators, traders, veterinarians and veterinary-related industries. It has
played a key role in the establishment of the single market, facilitating
intra-EU trade in animals and animal products (meat, milk, etc.) by setting up
harmonised animal health conditions and promoting the success of the CAP. 
The benefits of harmonised rules for the
prevention, notification, control and eradication of animal diseases at EU
level have been demonstrated during animal disease outbreaks in recent times.
The response to these crises showed the EU's capability to react quickly,
limiting the spread of diseases and minimising their impacts. This was largely
due to the harmonised approach to disease control, including providing
financial compensation for the losses on farms due to disease eradication
measures. Also, taking into account the single market dimension, the failure to
control a disease in one Member State, may severely affect the health status of
the Union and jeopardise its export potential. In light of these different
elements, EU action is justified, as it is clear that MS cannot achieve this
satisfactorily acting alone and that the EU would achieve a consistent approach
more effectively and efficiently.
Proportionality 
The Animal Health Law establishes a general
framework for the prevention, control and eradication of animal diseases. This
framework is built on outcome-based rules, avoiding over-prescriptiveness, and
leaving room for MS to regulate or set more detailed legislation when
necessary, so providing for the flexibility to adapt the rules to national,
regional or local circumstances. On the other hand, rules on trade must
necessarily have a certain level of detail and precision to reduce the risk of
different implementation practices by operators and competent authorities and
subsequent distortion of competition and possible reduction in the coherence of
the approach to tackling disease. Therefore the Animal Health Law tries to
achieve the balance of proportional but necessary action. 
4.           CONSULTATIONS WITH
INTERESTED 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 independent
evaluation to assess the performance of the Community Animal Health Policy
(CAHP)[3] over the previous decade
and its coherence with other EU policy interventions. The aim was to identify
elements of the CAHP which could be further improved and to propose options to
achieve these improvements. 
Among other things, the CAHP evaluation
recommended that a single strategy for animal health be developed to prevent
piecemeal and crisis-driven development of policy. The EU Animal Health
Strategy 2007-2013 (AHS) "Prevention is better than cure" was the
result[4].
The AHS provides for the adoption of a
"single regulatory framework for animal health with a greater focus on
incentives than penalties, consistent with other EU policies and converging to
international standards" and which will "define and integrate common
principles and requirements of existing legislation". In their reaction to
the Commission Communication on the new Strategy, the European Parliament[5],
the Council[6] and the European Economic
and Social Committee[7] welcomed this initiative.
Subsequently, the Action Plan for the implementation of the Strategy[8]
confirmed that "the main objective of the Strategy is the development of
an EU Animal Health Law".
From the very start of the process, key
stakeholders, Member States (MS), Competent Authorities (CA), international
organisations and trading partners have been closely involved and have played a
crucial role in the discussion. In addition, economic and social stakeholders
such as European associations with an interest in animal health and welfare and
the interested public have been consulted on a number of occasions in
accordance with the Commission’s standards for consultation. 
5.           ELEMENTS OF THE PROPOSAL
Part I: General Rules
The Animal Health Law sets out general
principles for good animal health in EU legislation. It brings together animal
health measures for terrestrial and aquatic animals. 
Part I also provides for the prioritisation and
listing of diseases which are likely to have a significant impact. For the
first time, this will enable Union resources to be systematically prioritised
on a scientific and evidential basis. 
The responsibilities of all the different actors
having a key role in the safeguarding of animal health, such as operators,
veterinarians, and pet keepers, are explicitly laid down for the first time. In
particular, operators and animal professionals are now required to acquire a
basic knowledge of animal health and related matters. 
Part II: Notification, Surveillance,
Eradication Programmes, Disease Freedom
Part II clarifies the responsibilities for
notification and surveillance including animal health visits. It clarifies the
roles of operators, competent authorities and others as regards surveillance of
the animal health situation in the Union. The new system allows for better use
of the synergies between surveillance undertaken by the different actors in the
field to ensure the most effective and cost efficient use of surveillance
resources.
Another main change here is that compartments,
permitted only for Avian Influenza related measures and in aquaculture at
present, can now be used more widely. This introduces more flexibility into
disease control measures, introducing the possibility of continuing movements
and trade under certain circumstances, considered from a risk-based perspective.

Part III: Disease Preparedness, Awareness and Control
Part III continues to require MSs to draw up contingency plans for
dealing with certain diseases, and to practise their implementation. 
The regulatory framework for vaccination is now
explicitly and coherently provided for. 
The rules for the use of antigen, vaccine and
reagent banks are laid down. 
Rules on control measures to be taken in the
case of suspicion of or confirmed disease outbreaks of certain diseases are
laid down, with little change to the existing system, which is considered to
work well. 
Part IV: Requirements Concerning
Registration, Approval, Traceability and Movements
Part IV is split into three titles, with
distinct rules for terrestrial, aquatic, and other animals. It is necessary to
consider them separately because of their different production methods and
epidemiology. The titles dealing with aquatic and terrestrial animals lay down
measures which help to identify and trace animals and establishments. The
traceability of animals is of crucial importance during a disease outbreak so
that the epidemiology of the disease is understood and can be better
controlled. These titles also introduce the possibility for more animals to be
registered and traced through electronic means, promoting simplicity and better
regulation, and reducing administrative burden through the use of technology. A
third title on other animals is introduced only for possible future provision,
should new threats emerge in relation to these animals. 
Part V: Entry into the Union and Export
Part V sets the standards and requirements for
third countries sending animals, germinal products, products of animal origin
and other material that may transmit animal diseases into the Union, in order
to prevent diseases being introduced. It also sets out requirements for export.
No practical changes are envisaged from existing legislation, which is
considered to function well. 
Part VI: Emergency Measures
Emergency measures are a crucial part of
disease management. Part VI lays down the procedures to be followed in case of
emergency, ensuring a rapid and consistent Union response. Only a few practical
changes are envisaged from existing legislation, which is considered to
function very well.
Part VII: Final and Transitional Provisions
The final and transitional provisions set out
the national provisions, the conditions for adopting delegated acts, repeals,
and other necessary legal provisions. 
6.           BUDGETARY
IMPLICATIONS
This proposal does not imply expenditures which are not already included
in the financial statement of the common financial framework for food chain,
animal health and welfare, and relating to plant health and plant reproductive
material.
2013/0136 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on Animal Health
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 43(2), Article
114(3) and Article 168(4)(b) thereof,
Having regard to the proposal from the
European Commission,
After transmission of the draft legislative
act to the national Parliaments,
Having regard to the opinion of the
European Economic and Social Committee[9], 
Having regard to the opinion of the
Committee of the Regions[10], 
Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)       The impact of
transmissible animal diseases and the measures necessary to control these
diseases can be devastating for individual animals, animal populations, animal
keepers and the economy. 
(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 regard to biodiversity, climate change
and other environmental aspects. Climate change may influence the emergence of
new diseases, the prevalence of existing diseases and the geographic
distribution of disease agents and vectors, including those affecting wildlife.
(4)       In order to ensure high
standards of animal and public health in the Union, the rational development of
the agriculture and aquaculture sectors and to increase productivity, animal
health rules should be laid down at Union level. These rules are necessary,
inter alia, to contribute to the completion of the internal market, and to avoid
the spread of infectious diseases. 
(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 and products, disease eradication, veterinary controls,
notification of diseases and financial support in relation to different animal
species, but an overarching legal framework, providing harmonised principles
across the sector is missing. 
(6)       The Animal Health Strategy
for the Union (2007– 2013) proposes that ‘Prevention is better than cure’ and
was adopted by the Commission in its Communication of 19 September 2007 to the
European Parliament, the Council, the European Economic and Social Committee
and the Committee of the 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 proposes the adoption of a “single
and simplified regulatory framework for animal health” seeking convergence to
international standards while ensuring a firm commitment to high standards of
animal health.
(7)       The aim of this Regulation
is to implement the commitments and visions provided for in that Animal Health
Strategy, including the "One health" principle, and to consolidate
the legal framework for a common Union animal health policy through a single,
simplified, and flexible regulatory framework for animal health.
(8)       Animals may suffer from a
broad range of infectious or non-infectious diseases. Many diseases can be
treated, have an impact only on the individual animal concerned or do not
spread to other animals or to humans. On the other hand, transmissible diseases
may have a broader impact on animal or public health with effects felt on a
population level. The animal health rules laid down in this Regulation should
only be limited to those latter diseases.
(9)       In laying down those animal
health rules, it is essential that considerations are given to the link between
animal health and public health, the environment, food and feed safety, animal
welfare, food security, economic, social and cultural aspects.
(10)     Council Decision 94/800/EC of 22 December 1994
concerning the conclusion on behalf of the European Community, as regards
matters within its competence, of the agreements reached in the Uruguay Round
multilateral negotiations (1986-1994)[12] approved on behalf of
the then European Community, with regard to that portion of those matters which
falls within its competence the Agreement establishing the World Trade
Organization (WTO), and also the Agreements set out in Annexes 1, 2 and 3 to
that Agreement which include the Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS Agreement). The SPS Agreement regulates the use of
measures necessary to protect human, animal or plant life or health so that
they do not arbitrarily or unjustifiably discriminate between WTO members. If
international standards exist, they are required to be used as a basis.
However, the members have the right to set their own relevant standards
provided that such standards are based on scientific evidence. 
(11)     As regards animal health
the SPS Agreement refers to the standards of the World Organisation for Animal
Health (OIE) as regards animal health conditions for international trade. In
order to reduce the risk of trade disruption, EU measures on animal health
should aim for an appropriate level of convergence with OIE standards.
(12)     In specific circumstances
where a significant animal or public health risk exists but scientific
uncertainty persists, Article 5(7) of the SPS Agreement which has been
interpreted for the Union in the Communication from the Commission of 2
February 2000 on the precautionary principle[13] allows a
Member of that agreement to adopt provisional measures on the basis of
available pertinent information. In such circumstances, the WTO Member is
required to obtain the additional information necessary for a more objective
assessment of risk and review the measure accordingly within a reasonable
period of time. 
(13)     The risk assessment, on the
basis of which the measures under this Regulation are taken, should be based on
the available scientific evidence and undertaken in an independent, objective
and transparent manner. Due account should also be taken of the opinions of the
European Food Safety Authority established by Article 22(1) of Regulation (EC)
No 178/2002 of the European Parliament and of the Council of 28 January 2002
laying down the general principles and requirements of food law, establishing
the European Food Safety Authority and laying down procedures in matters of
food safety[14].
(14)     Regulation (EC) No
1069/2009 of the European Parliament and the Council of 21 October 2009
laying down health rules as regards animal by-products and derived products not
intended for human consumption and repealing Regulation (EC) No. 1774/2002
(Animal by-products Regulation)[15] lays down both public
and animal health rules for certain animal by-products and derived products in
order to prevent and minimise risks to public and animal health arising from
those products, and in particular to protect the safety of the food and feed
chain. In order to avoid any overlap of Union legislation, this Regulation
should therefore only apply to animal by-products and derived products where
specific rules are not laid down in Regulation (EC) No 1069/2009, and where an
animal health risk is involved. For instance, Regulation (EC) No 1069/2009 does
not regulate how to handle animal by-products and derived products in the
context of disease control measures, and so these issues are duly covered by
this Regulation. 
(15)     In addition, specific rules
on transmissible animal diseases including those transmissible to humans ("zoonoses")
are already laid down in Regulation (EC) No 999/2001 of the European Parliament
and of the Council of 22 May 2001 laying down rules for the prevention, control
and eradication of certain transmissible spongiform encephalopathies[16],
Directive 2003/99/EC of the European Parliament and of the Council of 17
November 2003 on the monitoring of zoonoses and zoonotic agents, amending
Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC[17]
and Regulation (EC) No 2160/2003 of the European Parliament and of the Council
of 17 November 2003 on the control of salmonella and other specified food-borne
zoonotic agents[18], and specific rules on communicable
diseases in humans in Decision No 2119/98/EC of the European Parliament and of
the Council of 24 September 1998 setting up a network for the epidemiological
surveillance and control of communicable diseases in the Community[19].
Those acts should remain in force following the adoption of this Regulation. Accordingly,
in order to avoid any overlap of Union legislation, this Regulation should only
apply to zoonoses to the extent that specific rules are not already laid down
in those other Union acts.
(16)     Diseases occurring in wild
animal populations may have a detrimental effect on the agriculture and
aquaculture sectors, on public health, the environment and biodiversity. It is
therefore appropriate that the scope of this Regulation should, in such cases,
cover wild animals, both as potential victims of those diseases and as their
vectors. 
(17)     Animal diseases are not
only transmitted through direct contact between animals or between animals and
humans. They are also carried further afield through water and air systems,
vectors such as insects, or the semen, ova and embryos used in artificial
insemination, ovum donation or embryo transfer. Disease agents may also be
contained in food and other products of animal origin such as leather, fur,
feathers, horn and any other material derived from the body of an animal. Moreover various other objects such as transport
vehicles, equipment, fodder and hay and straw may diffuse disease agents.
Therefore, effective animal health rules need to cover all paths of infection
and material involved therein.
(18)     Animal diseases may have
detrimental effects on the distribution of animal species in the wild, and thus
affect biodiversity. Microorganisms causing animal diseases can therefore fall
within the definition of invasive alien species of the United Nations
Convention on Biological Diversity. The measures provided for in this
Regulation also take account of biodiversity and thus this Regulation should cover
animal species and disease agents, including those defined as invasive animal
species, which play a role in the transmission of, or are affected by, diseases
covered by this Regulation. 
(19)     In Union legislation
adopted prior to this Regulation separate animal health rules are laid down for
terrestrial and aquatic animals. Council Directive 2006/88/EC of 24 October
2006 on animal health requirements for aquaculture animals and products
thereof, and on the prevention and control of certain diseases in aquatic
animals[20] lays down specific rules
for aquatic animals. Yet in most cases, the main principles for good animal
health governance are applicable to both groups of animal species. Accordingly,
the scope of this Regulation should cover both terrestrial and aquatic animals
and aligns those animal health rules where applicable. However, for certain
aspects, in particular the registration and approval of establishments and the traceability
and movements of animals within the Union, this Regulation adheres to the
approach adopted in the past, which was to lay down different sets of animal
health rules for terrestrial and aquatic animals due to their different environments
and accordingly different requirements to safeguard health.
(20)     Union legislation adopted
prior to this Regulation and in particular Council Directive 92/65/EEC of 13
July 1992 laying down animal health requirements governing trade in and imports
into the Community of animals, semen, ova and embryos not subject to animal
health requirements laid down in specific Community rules referred to in Annex
A (I) to Directive 90/425/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 aquatic
or terrestrial animals as defined in this Regulation. Usually, such species do not
represent a significant health risk for humans or other animals and therefore
only a few animal health rules, if any, apply. In order to avoid unnecessary
administrative burdens and costs, this Regulation should adhere to the approach
adopted in the past, namely to provide the legal framework for detailed animal
health rules for movements of such animals and their products to be laid down if
the risks involved so require.
(21)     The keeping of pet animals,
including ornamental aquatic animals in households and non-commercial
ornamental aquaria, both indoors and outdoors, generally represents a lower
health risk compared to other ways of keeping or moving animals on a broader
scale, such as those common in agriculture. Therefore, it is not appropriate
that the general requirements concerning registration, record keeping and
movements within the Union apply to such animals, as this would represent an
unjustified administrative burden and cost. Registration and record keeping
requirements should therefore not apply to pet keepers. In addition, specific rules
should be laid down for non-commercial movements of pet animals within the
Union.
(22)     Some defined groups of
animals, for which special animal health rules exist in this Regulation, need
to be listed as species in an Annex, due to the broad scope of the group. This
is the case for the group of hoofed mammals classified as ungulates. This list
may need to be changed in the future due to reasons of changed taxonomy,
scientific development or technical updates justified by science. Similarly,
the list of species of pet animals may need to be adjusted due to developments
in society, or changed habits of keeping pet animals, in particular where these
animals transmit diseases. Therefore, in order to take account of such changes,
the power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission in
respect of the lists of pet animals and ungulates set out in Annexes I and II
to this Regulation. 
(23)     Not all transmissible
animal diseases can or should be prevented and controlled through regulatory
measures, for example, if the disease is too widespread, diagnostic tools are
not available, or if the private sector can take measures to control the
disease by itself. Regulatory measures to prevent and control transmissible animal
diseases may have important economic consequences for the relevant sectors and
disrupt trade. It is therefore essential that such measures are only applied
when proportionate and necessary, such as when a disease presents or is
suspected to present a significant risk to animal or public health. 
(24)     Furthermore, the preventive
and control measures for each transmissible animal disease should be
"tailor-made" in order to address its unique epidemiological profile
and its consequences. The preventive and control rules applying to each of them
should therefore be disease specific.
(25)     For transmissible animal diseases
a disease condition is usually associated with clinical or pathological
manifestation of the infection. However, for the purpose of this Regulation,
which aims to control the spread of and eradicate certain transmissible animal diseases,
the disease definition should be wider in order to include other carriers of
the disease agent.
(26)     Some transmissible animal diseases
do not easily spread to other animals or to humans and thus do not cause
economic or biodiversity damage on a wide scale. Therefore, they do not
represent a serious threat to animal or public health in the Union and can
thus, if desired, be addressed by national rules. 
(27)     For transmissible animal diseases
that are not subject to measures laid down at Union level, but which are of some
economic importance for the private sector at a local level, the latter should,
with the assistance of the competent authorities of the Member States, take
actions to prevent or control such diseases, for instance through
self-regulatory measures or the development of codes of practice.
(28)     In contrast to the transmissible
animal diseases described in recitals 26 and 27, highly transmissible animal diseases
may easily spread across borders and, if they are also a zoonosis, they may
also have an impact on public health and food safety. Hence highly transmissible
animal diseases and zoonoses should be covered by this Regulation. 
(29)     Action No. 5 of the
Communication from the Commission to the European Parliament and the Council –
Action plan against the rising threats from Antimicrobial Resistance[22]
emphasises the preventive role of this Regulation and the consequent expected reduction
of the use of antibiotics in animals. Resistance of microorganisms to
antimicrobials to which they were previously responsive is increasing. This resistance
complicates the treatment of infectious diseases in humans and animals. As a
result, microorganisms that have developed resistance to antimicrobials should
be treated as if they were transmissible diseases, and thus covered by the
scope of this Regulation.
(30)     New hazards associated with
certain diseases or species may develop in particular due to changes in the
environment, the climate, animal husbandry, farming traditions but also through
social changes. Scientific progress may also lead to new knowledge and
increased awareness concerning existing diseases. Furthermore, diseases and
species that are important today may be marginalised in the future. Therefore
the scope of this Regulation should be broad and the rules laid down should be
focused on diseases with high public relevance. The OIE has, with the support
of the European Commission, developed a system of disease prioritisation and
categorisation, by producing a study on the "Listing and categorisation of
priority animal diseases, including those transmissible to humans"[23]
and a tool for such an exercise. This Regulation should introduce such an
approach in Union legislation. 
(31)     In order to ensure uniform conditions
for the implementation of this Regulation in relation to transmissible animal diseases
at Union level, it is necessary to establish a harmonised list of transmissible
animal diseases ('listed diseases'). Thus implementing powers to lay down such
a list should be conferred on the Commission. 
(32)     Emerging diseases with the
potential to cause serious public or animal health risks and impacts on health,
the economy or the environment may appear in the future. Following the
assessment of such diseases and after adopting temporary emergency measures,
when relevant, a quick reaction and insertion of such diseases in the list of listed
diseases may be necessary. Therefore the power to adopt acts in accordance with
the urgency procedure should be delegated to the Commission in these duly
justified cases of risks to public or animal health.
(33)     Listed diseases will
require different management approaches. Some highly contagious diseases which
are currently not present in the Union require stringent measures to
immediately eradicate them as soon as they occur. For other diseases that might
already be present in parts of the Union, compulsory or voluntary eradication is
required. In both cases, it is appropriate to put in place restrictions on
movements of animals and products, such as a prohibition of movements to and
from affected areas, or simply testing prior to dispatch. In other instances it
might be appropriate only to implement surveillance of the disease's
distribution, without taking further measures. This would be the case, in
particular, in the event of an emerging disease for which there is limited
information. 
(34)     Criteria should be laid
down to ensure that all relevant aspects are considered when determining which transmissible
animal diseases should be listed for the purposes of this Regulation and to
determine the applicability of disease prevention and control rules of the
Regulation to the different listed diseases to ensure coherence and
consistency. In order to ensure that technical and scientific progress and
developments of relevant international standards are taken into account, the
power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission with respect
to the possible amendments of those criteria. 
(35)     The prevention and control rules
of this Regulation for a specific transmissible animal disease should apply to
species of animals which can transmit the disease in question, by being
susceptible to it or by acting as its vector. In order to ensure uniform
conditions for the implementation of this Regulation, it is necessary to
establish a harmonised list of species to which the measures for specific listed
diseases should apply at Union level ('listed species') and thus implementing
powers to lay down such a list should be conferred on the Commission.
(36)     Based on the importance and
the level of impact of a listed disease, its distribution, prevalence and
incidence in the Union and the availability of disease prevention and control
measures in respect of that listed disease, a different category of specific disease
prevention and control rules provided for in this Regulation should apply coherently
and consistently to each listed disease. 
(37)     In order to ensure uniform
conditions for the implementation of this Regulation in relation to the disease
prevention and control measures applicable to listed diseases, it is necessary
to determine the application of the rules, provided for in this Regulation, to
listed diseases at Union level. Thus implementing powers to lay down which
listed diseases are to be subject to which rules, should be conferred on the
Commission. 
(38)     Operators, animal
professionals and pet keepers working with animals are in the best position to
observe and ensure the health of the animals and products under their
responsibility. They should therefore hold primary responsibility for carrying out
measures for the prevention and control of the spread of diseases among animals
and products under their responsibility. 
(39)     Biosecurity is one of the
key prevention tools at the disposal of operators, and others working with
animals to prevent the introduction, development and spread of transmissible
animal diseases to, from and within an animal population. The role of
biosecurity is also recognised in the Impact Assessment for the adoption of the
EU Animal Health Law and possible impacts are specifically assessed. In order
to ensure that the biosecurity measures applied by operators, animal
professionals and pet keepers are sufficiently flexible, that they are adjusted
to suit the type of production and the species or categories of animals
involved and that they take account of the local circumstances and technical
developments, the power to adopt acts in accordance with Article 290 of the Treaty
on the Functioning of the European Union should be delegated to the Commission with
respect to supplementary and more detailed biosecurity requirements. 
(40)     Biocidal products, such as
disinfectants for veterinary hygiene or food and feed areas, insecticides,
repellents or rodenticides play an important role in biosecurity strategies,
both at farm level as well as during animal transport. They should therefore be
considered a part of biosecurity. 
(41)     Knowledge of animal health,
including of disease symptoms, consequences of diseases and possible means of
prevention including biosecurity, treatment and control is a prerequisite for
efficient animal health management and essential in ensuring the early
detection of animal diseases. Operators and other animal professionals should
therefore acquire such knowledge as appropriate. That knowledge may be acquired
by different means, for example formal education, but also through the Farm
Advisory System existing in the agricultural sector or by informal training to
which national and European farmer organisations and other organisations may be
valuable contributors. Those alternative means of acquiring such knowledge should
also be recognised by this Regulation.
(42)     Veterinarians and aquatic
animal health professionals play a crucial role in all aspects of animal health
management, and general rules concerning their roles and responsibilities
should be laid down in this Regulation. 
(43)     Veterinarians have the
education and the professional qualifications which ensure that they have
acquired the knowledge, skills and competencies necessary, inter alia, to
diagnose diseases and treat animals. In addition, in some Member States for
historical reasons, or due to the lack of veterinarians dealing with aquatic
diseases, there exists a specialised profession called "aquatic animal
health professionals". These professionals are traditionally not
veterinarians but they practice aquatic animal medicine. This Regulation should
therefore respect the decision of those Member States who recognise that profession.
In those cases, aquatic animal health professionals should have the same
responsibilities and obligations as veterinarians concerning their specific
area of work. This approach is in line with the Aquatic Animal Health Code of
the OIE.
(44)     In order to ensure that the
veterinarians and aquatic animal health professionals who undertake activities that
fall within the scope of this Regulation are adequately qualified and receive
appropriate training, the power to adopt acts in accordance with Article 290 of
the Treaty on the Functioning of the European Union should be delegated to the
Commission in respect to their qualification and training.
(45)     Member States and in
particular the competent authority thereof responsible for animal health are amongst
the key actors in the prevention and control of transmissible animal diseases. The
competent authority for animal health plays an important role in relation to
surveillance, eradication, disease control measures, contingency planning,
raising disease awareness, and in the facilitation of animal movements and in international
trade by the issuing of animal health certificates. To be able to perform their
duties under this Regulation, Member States depend on having access to adequate
financial, infrastructural and personnel resources throughout their
territories, including laboratory capacity and scientific and other relevant
know-how. 
(46)     The competent authority
cannot always perform all the activities required to be carried out by it under
this Regulation due to the limited resources. For that reason it is necessary
to provide a legal basis for the delegation of the performance of those
activities to veterinarians. In order to ensure that the necessary conditions
are laid down for the general application of disease prevention and control
measures across the Union, the power to adopt acts in accordance with Article
290 of the Treaty on the Functioning of the European Union should be delegated
to the Commission in respect to the delegation of the performance of those activities
to veterinarians and their appropriate training.
(47)     Optimal animal health
management can only be achieved in cooperation with animal keepers, operators,
other stakeholders and trading partners. To secure their support it is
necessary to organise decision making procedures and the application of the measures
provided for in this Regulation in a clear and transparent manner. Therefore the
competent authority should take appropriate steps to keep the public informed,
especially when there are reasonable grounds to suspect that animals or
products may present a risk for animal or public health and when a case is of
public interest. 
(48)     To avoid the release of
disease agents from laboratories, institutes and other facilities handling diseases
agents it is vital that they take appropriate biosecurity, biosafety and bio-containment
measures. This Regulation should therefore provide for safety measures to be
observed while handling or transporting such disease agents, vaccines and other
biological products. This obligation should also apply to any legal or natural
person, who is involved in such an activity. In order to ensure that safety
standards are respected when handling highly contagious biological agents,
vaccines and other biological products, the power to adopt acts in accordance with
Article 290 of the Treaty on the Functioning of the European Union should be
delegated to the Commission in respect of the safety measures in those
laboratories, institutes and facilities and for movements of diseases agents.
(49)     Early detection and a clear
chain of disease notification and reporting are crucial for effective disease
control. In order to achieve an efficient and quick response any suspicion or
confirmation of an outbreak of certain listed diseases should be immediately notified
to the competent authority. Those notification obligations should be applicable
to any natural and legal person in order to ensure that no disease outbreaks
remain unnoticed.
(50)     Veterinarians are key
actors in the investigation of diseases and a key link between operators and
the competent authority. Therefore, they should be notified by the operator in
cases of abnormal mortalities, other serious disease problems or significantly
decreased production rates with an undetermined cause. 
(51)     In order to ensure the effective
and efficient notification and to clarify different circumstances related to
abnormal mortalities and other serious diseases signs, the power to adopt acts
in accordance with Article 290 of the Treaty on the Functioning of the European
Union should be delegated to the Commission in respect of criteria to determine
when relevant circumstances for the notification occur and the rules for further
investigation, where this is relevant.
(52)     For certain listed diseases
it is vital that the Commission and the other Member States are immediately notified
about diseases. Such Union notification will enable neighbouring or other
affected Member States to take precautionary measures when so warranted. In
order to ensure uniform conditions for the implementation of such Union notification,
implementing powers shall be conferred on the Commission.
(53)     On the other hand, for some
diseases immediate notification and action are not necessary. In those cases
the gathering of information and reporting in relation to the occurrence of
those diseases is essential to control the disease situation and where
necessary to take disease prevention and control measures. This reporting
requirement may also apply to diseases which are subject to Union notification
but where additional information is needed for the implementation of effective
disease prevention and control measures. In order to ensure that the correct
information and data, which are necessary to prevent the spread or to control
each particular disease, are collected in the right timeframe, the power to
adopt acts in accordance with Article 290 of the Treaty on the Functioning
of the European Union should be delegated to the Commission concerning the matters
to be reported.
(54)     A key purpose of disease
notification and reporting is to generate reliable, transparent and accessible
epidemiological data. A computerised information system for the effective
collection and management of surveillance data should be established at Union
level for listed diseases and, when relevant, for emerging diseases or
antimicrobial resistant pathogens. That system should promote optimal data
availability, facilitation of data exchange, and reduction of administrative
burden for the competent authorities of the Member States by merging disease
notification and reporting within the Union and at international level into one
process (that is the WAHIS/WAHID database of the OIE). Consistency with the
exchange of information in accordance with Directive 2003/99/EC[24]
should also be ensured. 
(55)     In order to ensure uniform conditions
for the implementation of the Union disease notification and reporting rules,
implementing powers should be conferred on the Commission to establish a list
of diseases which are subject to Union notification and Union reporting rules
provided for in this Regulation and to establish the necessary procedures,
formats, data and information exchanges regarding disease notification and
reporting.
(56)     Surveillance is a key
element of disease control policy. It should provide for the early detection of
transmissible animal diseases and efficient notification, thereby enabling the
sector and the competent authority to implement, where feasible, timely disease
prevention and control measures, and the eradication of a disease. Furthermore,
it should supply information on the animal health status of each Member State
and the Union, thereby substantiating disease freedom and facilitating trade
with third countries.
(57)     Operators observe their
animals on a regular basis and are best positioned to detect abnormal
mortalities or other serious disease symptoms. Operators are therefore the
cornerstone of any surveillance and essential for the surveillance undertaken
by the competent authority. 
(58)     To ensure close
collaboration and exchange of information between operators and veterinarians
or aquatic animal health professionals and to supplement the surveillance
undertaken by operators, establishments should, as appropriate for the type of
production and other relevant factors, be subject to animal health visits. In
order to ensure a proportionate level of surveillance to the risks involved in
different types of establishments, the power to adopt acts in accordance with
Article 290 of the Treaty on the Functioning of the European Union should be
delegated to the Commission concerning the criteria and the content of such
animal health visits in different types of establishments.
(59)     It is essential that the
competent authority has in place a system of surveillance for the listed diseases
which are subject to surveillance. This should also apply to emerging diseases,
where the potential health risks of that disease should be assessed and
epidemiological data collected for that assessment. To ensure the best use of
resources information should be collected, shared and used in the most
effective and efficient manner possible.
(60)     The surveillance
methodology, frequency and intensity should be adapted to each specific disease
and take into account the specific purpose of the surveillance, the animal
health status in the region concerned and any additional surveillance conducted
by operators. 
(61)     In some cases, and
depending on the epidemiological profile of a disease and relevant risk
factors, a structured surveillance programme may need to be put in place. In that
case it is appropriate that Member States develop epidemiologically based surveillance
programmes. The power to adopt acts in accordance with Article 290 of the
Treaty on the Functioning of the European Union should be delegated to the
Commission concerning the surveillance design, the criteria for official
confirmation of outbreaks and the case definitions of those diseases and
requirements for surveillance programmes in relation to their contents,
information to be included and the period of application. 
(62)     To promote coordination
between the Member States and ensure that those surveillance programmes are
consistent with Union objectives, they should be submitted to the Commission and
other Member States for information. Furthermore, the Member State implementing
the surveillance programme should also submit regular reports on the results of
that surveillance programme to the Commission. In order to ensure uniform
conditions for the implementation of surveillance programmes, implementing
powers should be conferred on the Commission to establish a list of diseases
subject to surveillance programmes and to set up harmonised procedures,
formats, data and information exchange.
(63)     Member States that are not
free or are not known to be free from listed diseases which are subject to
eradication measures as provided for in this Regulation, should be required to
establish compulsory eradication programmes to eradicate those diseases where
the eradication is compulsory in the Union, or have the possibility to establish
voluntary eradication programmes, to eradicate those diseases where the
eradication is envisaged in the Union, but is not compulsory. To ensure uniform
conditions of general application throughout the Union, it is necessary to lay
down harmonised requirements for such compulsory or voluntary eradication programmes.
In order to ensure effective disease eradication, the power to adopt acts in
accordance with Article 290 of the Treaty on the Functioning of the European
Union should be delegated to the Commission in respect of the objectives of
disease control strategies, disease control 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 declaring the whole of their territories, zones
or compartments thereof free of one or more of listed diseases, which are
subject to rules on compulsory or voluntary eradication programmes, in order to
be protected against the introduction of such listed diseases from other parts
of the Union or from third countries or territories. A clear harmonised
procedure, including the necessary criteria for disease-free status, should be
established for that purpose. In order to ensure uniform conditions for the
implementation of the recognition of disease-free status within the Union it is
necessary that such a disease-free status is officially approved and thus
implementing powers to approve such status should be conferred on the
Commission.
(66)     The OIE has introduced the
concept of compartmentalisation in the framework of the Terrestrial and Aquatic
Animal Health Codes (the OIE Codes). In Union legislation adopted prior to this
Regulation, that concept is only recognised for particular animal species and
diseases, specified in specific Union legislation, namely for avian influenza
and aquatic animal diseases. This Regulation should establish the possibility
of using the compartment system for other animal species and diseases. In order
to lay down the detailed conditions for the recognition, rules for approval and
the requirements for compartments, the power to adopt acts in accordance with
Article 290 of the Treaty on the Functioning of the European Union should be
delegated to the Commission.
(67)     Member States should make
their disease-free territory, zones and compartments thereof publicly known for
the purpose of informing trading partners and facilitating trade. 
(68)     In order to lay down the
detailed conditions for the recognition of disease-free status, the power to
adopt acts in accordance with Article 290 of the Treaty on the Functioning of
the European Union should be delegated to the Commission in respect of the
criteria for obtaining such status, the evidence needed to substantiate freedom
from disease, special disease prevention and control measures, restrictions,
information to be provided, derogations, and conditions for the maintenance,
suspension, withdrawal or restoration of disease-free status.
(69)     In order to ensure uniform
conditions for the implementation of procedures to obtain disease free status,
implementing powers should be conferred on the Commission to establish the
listed diseases which may be subject to compartmentalisation and lay down detailed
rules on formats for the submission of applications and information exchange.
(70)     The presence of an entirely
non-immune population of animals, susceptible to certain listed diseases,
requires permanent disease awareness and preparedness. Contingency plans have
proved to be a crucial tool for the successful control of disease emergencies
in the past. In order to ensure this effective and efficient tool for the
control of disease emergencies, which is flexible to adjust to the emergency
situations, the power to adopt acts in accordance with Article 290 of the
Treaty on the Functioning of the European Union should be delegated to the
Commission in respect of the detailed requirements and conditions for
contingency plans.
(71)     Past animal health crises
have shown the benefits of having specific, detailed and rapid management
procedures for disease emergencies. Those organisational procedures should
ensure a rapid and effective response and improve coordination of efforts of
all involved parties, and in particular the competent authorities and the
stakeholders.
(72)     To ensure the applicability
of contingency plans in real emergency situations, it is essential to practise
and test that the systems are working. For that purpose the competent
authorities of the Member States should carry out simulation exercises, in
cooperation with the competent authorities of the neighbouring Member States
and third countries and territories, where feasible and relevant.
(73)     In order to ensure uniform
conditions for the implementation of contingency plans and simulation exercises,
implementing powers should be conferred on the Commission to lay down rules for
the practical implementation of those plans and exercises.
(74)     Veterinary medicinal
products such as vaccines, hyper immune sera and antimicrobials play an
important role in the prevention and control of transmissible animal diseases.
The Impact Assessment for the adoption of the EU Animal Health Law highlights
in particular the importance of vaccines as a tool in the prevention, control
and eradication of animal diseases. 
(75)     However, control strategies
for some transmissible animal diseases require prohibition or restriction of the
use of certain veterinary medicinal products, as their use would hamper the
effectiveness of those strategies. For example, hyper immune sera or
antimicrobial agents may mask the expression of a disease, make the detection
of a disease agent impossible or render a swift and differential diagnosis
difficult and thus endanger the correct detection of disease.
(76)     However, those control strategies
may substantially vary between different listed diseases. Thus this Regulation
should provide for rules on the use of veterinary medicinal products for the
prevention and control of listed diseases and for harmonised criteria for
consideration when determining whether or not to use and how to use vaccines,
hyper-immune sera and antimicrobials. In order to ensure a flexible approach
and to address the specificities of different listed diseases and the availability
of the effective treatments, the power to adopt acts in accordance with Article
290 of the Treaty on the Functioning of the European Union should be delegated
to the Commission in respect of the restrictions, prohibitions or obligations
to use certain veterinary medicinal products in the framework of the control of
certain listed diseases. In the case of urgency and in order to address
emerging risks with possible devastating implications for animal or public health,
economy, society or environment, it should be possible for these measures to be
adopted by the urgency procedure. 
(77)     Following the conclusions
of the Expert opinion on vaccine and/or diagnostic banks for major animal
diseases[25] it should also be made
possible for the Union and the Member States to establish reserves of antigens,
vaccines and diagnostic reagents for listed diseases that represent a serious
threat for animal or public health. The establishment of a Union antigen,
vaccine and diagnostic reagent bank would promote the Union's animal health
objectives by enabling a quick and effective response when its resources are
required and represents an efficient use of limited resources. 
(78)     In order to ensure such a
quick and effective response, the power to adopt acts in accordance with
Article 290 of the Treaty on the Functioning of the European Union should be
delegated to the Commission, in respect of the establishment and the management
of such banks, and safety standards and requirements for the operation of
those. However, this Regulation should not provide for the rules on the
financing of the disease preventive and control measures, including
vaccination.
(79)     Criteria for priority
access to the Union antigen, vaccine and diagnostic reagent banks' resources
should be established in order to ensure their effective distribution in
emergencies. 
(80)     For reasons of security in
relation to bio-terrorism and agro-terrorism, certain detailed information
concerning the Union antigen, vaccine and diagnostic reagent banks should be
treated as classified information and its publication should be prohibited.
(81)     In order to ensure uniform
conditions for the management of the Union antigen, vaccine and diagnostic
reagent banks, implementing powers should be conferred on the Commission to lay
down detailed rules concerning which biological products are to be included in
those banks and for which diseases, and detailed rules on the supply, quantities,
storage, delivery, procedural and technical requirements for vaccines, antigens
and diagnostic reagents and the frequency and content of submissions of
information to the Commission.
(82)     In the event of an outbreak
of a listed disease considered to represent a high risk to animal or public
health in the Union, it is necessary to take immediate disease control measures
to eradicate that listed disease in order to protect animal and public health
and the relevant sectors.
(83)     Operators, animal
professionals and pet keepers should have the primary responsibility for
controlling and preventing the spread of transmissible animal diseases. They
should take immediate action in case of suspicion or confirmation of highly
contagious diseases. 
(84)     The competent authority should
be responsible for initiating the first investigations to confirm or rule out
an outbreak of a highly contagious listed disease, considered to represent a
high risk to animal or public health in the Union. 
(85)     The competent authority should
put in place preliminary disease control measures to prevent the possible
spread of the listed disease and undertake an epidemiological enquiry.
(86)     As soon as a listed disease
is confirmed the competent authority should take the necessary disease control
measures, if necessary including the establishment of restricted zones, to
eradicate and prevent the further spread of that disease.
(87)     The occurrence of a listed
disease in wild animals may pose a risk to public health and the health of kept
animals. Special rules should therefore be laid down for disease control and
eradication measures in wild animals where needed. 
(88)     For listed diseases, which
are not highly contagious, and which are subject to compulsory eradication, the
disease control measures should be implemented to prevent the spread of those listed
diseases, in particular to non-infected areas. However, those measures may be
more limited or different comparing to those applicable for the most dangerous
listed diseases. This Regulation should therefore provide for special rules for
those diseases. Member States that have a voluntary eradication programme in
place, should also implement such disease control measures. However, the level
and intensity of disease control measures should be proportionate and take into
account the characteristics of the listed disease in question, its distribution
and its significance for the Member State concerned by it and the Union as a
whole. 
(89)     In order to ensure the
effective application of the disease control measures provided for in this
Regulation by operators, pet keepers and the competent authorities and taking
into account the specificities of the disease control measures for particular listed
diseases and the risk factors involved, the power to adopt acts in accordance
with Article 290 of the Treaty on the Functioning of the European Union should
be delegated to the Commission, in respect of the detailed disease control
measures in the event of suspicion or confirmation of a listed disease in
establishments, other locations and restricted zones.
(90)     In order to provide for the
possibility for special disease control measures to be adopted by the
Commission on a temporary basis in the event that the disease control measures laid
down in this Regulation are not sufficient or appropriate to address that risk,
implementing powers should be conferred on the Commission concerning the laying
down of special disease control measures for a limited period of time.
(91)     The registration of certain
transporters and establishments keeping terrestrial animals or handling
germinal products or transporting them is necessary to allow the competent authorities
to perform adequate surveillance and to prevent, control and eradicate transmissible
animal diseases. 
(92)     Where a certain type of
establishment keeping terrestrial animals or handling or storing germinal
products poses a particular animal health risk, it should be subject to
approval by the competent authority. 
(93)     To avoid unjustified
administrative burdens and costs, particularly to small and medium size
enterprises (SMEs), flexibility should be given to the Member States to adapt
the system of registration and approval to local and regional conditions and
production patterns.
(94)     In the interest of reducing
administrative burdens, registration and approvals should, where possible, be
integrated into a registration or approval system which Member State may
already have established for other purposes. 
(95)     Operators have first-hand
knowledge of the animals under their care. They should therefore maintain
up-to-date records of information which are relevant for assessing the animal
health status, for traceability and for an epidemiological enquiry in the event
of the occurrence of a listed disease. Those records should be easily
accessible to the competent authority. 
(96)     In order to ensure the
public availability of up-to-date information concerning the registered establishments
and transporters and approved establishments the competent authority should
establish and keep a register of such establishments and transporters. The
power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission, in
respect of the information to be contained in the register of establishments
and transporters and the record keeping requirements, as regards the
information to be recorded, derogations from the record keeping requirements
and the specific additional requirements for germinal products.
(97)     In order to ensure uniform
conditions for the implementation of the requirements laid down in this
regulation on the registration and approval of establishments and on the record
keeping and registers, implementing powers should be conferred to the
Commission to lay down rules concerning the information obligations, exemptions
and other rules, the formats and operational specifications of the registers
and records.
(98)     Efficient traceability is a
key element of disease control policy. Identification and registration
requirements specific for the different species of kept terrestrial animals and
germinal products should be in place in order to facilitate the effective
application of the disease prevention and control rules provided for in this
regulation. In addition, it is important to provide for the possibility of
establishing an identification and registration system for species for which
such arrangements do not exist at present, or when changing circumstances and
risks so warrant.
(99)     In order to ensure the
smooth operation of the identification and registration system and ensure
traceability, the power to adopt acts in accordance with Article 290 of the
Treaty on the Functioning of the European Union should be delegated to the
Commission, in respect of the obligations concerning databases, designation of the
competent authority, detailed identification and registration requirements for
different animal species and documents. 
(100)   It is appropriate to reduce administrative
burdens and costs and provide for flexibility of the system in circumstances
where the traceability requirements can be achieved by means other than those
set out in this Regulation. The Commission should therefore be empowered to
adopt delegated acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union concerning the derogations from the
identification and registration requirements.
(101)   In order to ensure uniform
conditions for the implementation of the identification and registration system
and traceability, implementing powers should be conferred on the Commission to
lay down rules concerning the technical specifications for databases, means of
identification, documents and formats, the deadlines, and criteria for derogations
from such systems.
(102)   An important tool for
preventing the introduction and spread of a transmissible animal disease is the
use of restrictions on movements of animals and products that may transmit that
disease. However, restricting the movement of animals and products may have a severe
economic impact and interfere with the operation of the internal market. Such
restrictions should therefore only be applied where necessary and proportionate
to the risks involved. This approach is in line with the principles laid down
in the SPS Agreement and the OIE international standards.
(103)   The general requirements
laid down in this Regulation should apply to all animal movements, such as the
prohibition of movement of animals from an establishment where there are
abnormal mortalities or other disease symptoms with an undetermined cause or
disease prevention requirements during transport. 
(104)   The legal framework,
currently laid down in Union legislation for the movement of terrestrial
animals lays down harmonised rules primarily for the movement of terrestrial
animals and products between Member States, while leaving it up to the Member
States to determine the necessary movement requirements within their territory.
A comparison of the current situation with an option where rules for movements
within Member States would also be harmonised at Union level, was extensively
elaborated in the Impact Assessment on the EU Animal Health Law. It has been
concluded that the current approach should be maintained, as complete
harmonisation of all movements would be very complex and the benefits in terms
of the facilitation of movements between Member States do not outweigh the
negative impact this could have on the ability to control diseases. 
(105)   For animals that are moved
between Member States a set of basic animal health requirements apply. In
particular, animals may not be moved from establishments with abnormal
mortalities or signs of disease of unknown cause. However, mortalities, even if
abnormal, which are linked to scientific procedures authorised under Directive
2010/63/EU of the European Parliament and of the Council of 22 September
2010 on the protection of animals used for scientific 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. 
(106)   However, this Regulation
should provide for flexibility to facilitate the movement of species and
categories of terrestrial animals, which represent a low risk for spreading listed
diseases between Member States. In addition, further possibilities for
derogations should be provided for in cases where Member States or operators
successfully put in place alternative risk mitigating measures such as high
levels of biosecurity and effective surveillance systems.
(107)   Ungulates and poultry are groups
of animal species of high economic significance and are subject to specific movement
requirements under Union legislation adopted prior to this Regulation, namely Council
Directive 64/432/EEC of 26 June 1964 on animal health problems affecting
intra-Community trade in bovine animals and swine[27],
Council Directive 91/68/EEC of 28 January 1991 on animal health conditions
governing intra-Community trade in ovine and caprine animals[28],
Council Directive 2009/156/EC of 30 November 2009 on animal health conditions
governing the movement and importation from third countries of equidae[29],
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[30] and partially Council
Directive 92/65/EEC of 13 July 1992 laying down animal health requirements
governing trade in and imports into the Community of animals, semen, ova and
embryos not subject to animal health requirements laid down in specific
Community rules referred to in Annex A (I) to Directive 90/425/EEC[31].
The main rules for the movement of those species should be laid down in this
Regulation. The detailed requirements which largely depend on the diseases that
may be transmitted by different species or categories of animals should be
regulated in subsequent Commission acts, taking into account the specificities
of the diseases, species and categories of animals in question.
(108)   As assembly operations for
ungulates and poultry represent a particularly high disease risk, it is
appropriate to lay down specific rules in this Regulation to protect the health
of the animals involved and prevent the spread of transmissible animal diseases.
(109)   Depending on the listed
diseases and listed species, it is necessary to lay down specific animal health
requirements for certain animal species other than kept ungulates and poultry. Rules
for these species were also laid down in the legal framework applicable prior
to this Regulation and in particular in Directive 92/65/EEC. That Directive
lays down specific movement rules for animal species including bees, bumble
bees, apes, dogs and cats etc. and this Regulation should therefore provide a
legal basis for the adoption of delegated and implementing acts laying down specific
movement rules for those animal species. 
(110)   Confined establishments, usually
used for the keeping of laboratory animals or zoo animals, normally involve a
high level of biosecurity, a favourable and well controlled health status and are
subject to fewer movements or movements solely within the closed circuits of those
establishments. The status of confined establishments, for which the operators may
apply for on a voluntary basis, was first introduced in Directive 92/65/EEC,
where rules and requirements for approval and movement requirements for
approved bodies, institutes and centres are laid down. That system enables
those establishments to exchange animals amongst themselves with fewer movement
requirements and at the same time providing health guarantees within the
circuit of confined establishments. Therefore it has been broadly accepted by
the operators, and used as a voluntary option. It is therefore appropriate to preserve
the concept of confined establishments and also to lay down rules for movement between
those establishments in this Regulation. 
(111)   For scientific purposes,
such as research or diagnostic purposes, and in particular those authorised in
accordance with Directive 2010/63/EU, it may be necessary to move animals which
do not comply with the general animal health requirements laid down in this
Regulation and represent a higher animal health risk. Those kinds of movements
should not be prohibited or unduly restricted by the provisions of this
Regulation, as this could impede otherwise authorised research activities and
delay scientific progress. Nonetheless, it is essential that rules are laid down
in this Regulation to ensure that movements of those animals take place in a
safe manner.
(112)   Movement patterns of circus
animals, animals kept in zoos, animals intended for exhibition and certain
other animals often deviate from the movement patterns of other kept species.
Specific consideration should be taken in adapting Union rules on movement to
such animals, taking into account specific risks and alternative risk
mitigation measures. 
(113)   In order to ensure that the
objectives of recitals 102 to 112 of this Regulation are achieved, the power to
adopt acts in accordance with Article 290 of the Treaty on the Functioning of
the European Union should be delegated to the Commission, concerning the
disease preventive measures in transport, specific rules for movement of
certain animal species and special circumstances, such as assembly operations or
rejected consignments, and special requirements or derogations for other types
of movements, such as movement for scientific purposes.
(114)   In order to ensure the possibility
for special rules for movements, where the movement rules are not sufficient or
appropriate to limit the spread of a certain disease, implementing powers
should be conferred on the Commission to lay down special movement rules for a
limited period of time.
(115)   Kept terrestrial animals
that are moved between Member States should comply with the requirements for
such movements. In the case of species presenting a health risk and of greater economic
importance, they should be accompanied by an animal health certificate issued
by the competent authority.
(116)   To the extent technically,
practically and financially feasible, technological developments should be
availed of to reduce the administrative burdens on operators and the competent authority
in relation to certification and notification by using information technology to
replace the paper documentation and facilitate notification procedures and using
them as far as possible for multiple purposes. 
(117)   In cases where an animal
health certificate issued by the competent authority is not required, an
operator who moves animals to another Member State should issue a
self-declaration document which confirms that the animals meet the movement
requirements laid down in this Regulation. 
(118)   In order to ensure the achievement
of the objectives referred to in recitals 115, 116 and 117 of this Regulation the
powers to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission, concerning
rules on the content, information obligations, and derogations from the animal
health certification requirements, specific certification rules and the
obligations of official veterinarians to conduct appropriate checks before the signing
the animal health certificate. 
(119)   Notification of movements of
animals and germinal products between Member States and in some cases within
the national territories of Member States is essential to ensure traceability
of animals and those germinal products, where these movements may be linked to
a risk of spreading transmissible animal diseases. Therefore, such movements should
be notified and registered. The IMSOC system provided for in Article 130(1) of
the Regulation (EU) No xxx/xxx of the European Parliament and of the Council on
official controls and other official activities performed to ensure the
application of food and feed law, rules on animal health and welfare, plant
health and plant reproductive material, plant protection products and amending
Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007,
1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013, and
Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and
2009/128/EC (Official controls Regulation)[32] [Publication
office] should be used for that purpose.
(120)   In order to ensure uniform
conditions for the implementation of the rules laid down in this Regulation on animal
health certification and movement notification, implementing powers should be
conferred on the Commission to lay down rules concerning the model animal
health certificates, self-declaration documents, formats and deadlines for
movement notification for both terrestrial and aquatic animals, germinal
products and where also relevant, products of animal origin. 
(121)   The specific nature of
movements of pet animals represents an animal health risk which deviates significantly
from that of other kept animals. Specific rules for such movements should
therefore be laid down in this Regulation. In order to ensure that pet animals
do not pose a significant risk for the spread of transmissible animal diseases,
the power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission in
respect of the detailed rules for movements of those animals. In order to
ensure uniform conditions for the implementation of the animal health
requirements laid down in this Regulation concerning the movements of pet
animals, implementing powers should be conferred on the Commission to lay down rules
concerning the disease prevention and control measures to be taken for such
movements. 
(122)   Wild animals may for various
reasons represent an animal and public health risk, for example, if they are
moved into an establishment or from one environment to another environment.
Appropriate preventive measures for movement of those animals may need to be
taken to avoid the spread of transmissible animal diseases. In order to ensure
that wild animals do not pose a significant risk for the spread of
transmissible animal diseases the power to adopt acts in accordance with
Article 290 of the Treaty on the Functioning of the European Union should be
delegated to the Commission, concerning the additional requirements for
movements of wild terrestrial animals.
(123)   Germinal products can
represent a similar risk of spreading transmissible animal diseases to live
animals. In addition, there are specificities in their production, which are
related to high health demands for breeding animals and which call for stricter
or particular animal health requirements concerning the donor animals. In order
to ensure safe movements of germinal products, their expected high health
standard and to take into account some specific uses, the power to adopt acts in
accordance with Article 290 of the Treaty on the Functioning of the European
Union should be delegated to the Commission, concerning the detailed requirements
for movement of germinal products of certain animal species, special
requirements, such as for example their movement for scientific purposes, and
derogations from the animal health certification obligation. 
(124)   Products of animal origin
can represent a risk for the spreading of transmissible animal diseases. Food
safety requirements for products of animal origin laid down in Union
legislation ensure good hygiene practices and reduce the animal health risks of
such products. However, for certain cases specific animal health measures, such
as disease control and emergency measures should be laid down in this
Regulation to ensure that products of animal origin do not spread animal
diseases. In order to ensure safe movements of products of animal origin in
these particular cases, the power to adopt acts in accordance with Article 290 of
the Treaty on the Functioning of the European Union should be delegated to the
Commission, concerning detailed rules for movements of products of animal
origin in relation to disease control measures taken, the obligations for
animal health certification and derogations from those rules, where the risk
involved with such movements and the risk mitigating measures in place permit
so. . 
(125)   When Member States take national
measures concerning movements of animals and germinal products or decide to
take national measures to limit the impact of transmissible animal diseases
other than listed diseases within their territory, those national measures
should not interfere with the rules on the internal market laid down in Union
legislation. Therefore, it is appropriate to set the framework for such national
measures and ensure that they remain within the limits permitted under Union
law. 
(126)   The registration and
approval of aquaculture establishments is necessary to allow the competent
authorities to perform adequate surveillance and to prevent, control and
eradicate transmissible animal diseases. Directive 2006/88/EC requires all
establishments which move aquatic animals to be authorised. That system of
authorisation should be maintained under this Regulation, notwithstanding that
fact that in some official EU languages, different terms are used for this
system of authorisation in this Regulation as compared to Directive 2006/88/EC.
(127)   The slaughter and processing
of aquaculture animals which are subject to disease control measures may spread
transmissible animal disease, for example as a result of effluents containing
pathogens being discharged from processing establishments. It is therefore
necessary to approve processing establishments which fulfil the risk mitigation
measures to undertake such slaughter and processing. Therefore, this Regulation
should provide for the approval of disease control aquatic food establishments.
(128)   In order to ensure the
public availability of up-to-date information concerning registered and
approved establishments the competent authority should establish and keep such
a register. The power to adopt acts in accordance with Article 290 of the Treaty
on the Functioning of the European Union should be delegated to the Commission,
concerning the information to be included in register of aquaculture establishments
and the record keeping requirements for aquaculture establishments and
transporters.
(129)   In order to ensure uniform
conditions for the implementation of the rules laid down in this Regulation for
the registration and approval of aquaculture establishments and disease control
aquatic food establishments, record keeping and registers of establishments,
implementing powers should be conferred on the Commission to lay down rules
concerning the information obligations, derogations and other implementing
rules, and the format and operational specifications of the registers and
records.
(130)   As it is not feasible in
most cases to individually identify aquatic animals, the keeping of records at
aquaculture establishments, disease control aquatic food establishments and by
transporters is an essential tool in ensuring the traceability of aquatic animals.
Records are also valuable for the surveillance of the health situation of
establishments.
(131)   Similarly to terrestrial
animals, it is necessary to lay down harmonised rules on the movement of
aquatic animals, including rules on animal health certification and movement notification.

(132)   Directive 2006/88/EC lays
down rules for movements of aquatic animals, which apply equally to movements
within and between Member States. The key determining factor for movement rules
for aquatic animals is the health status as regards the listed diseases of the
Member State, zones and compartments of destination.
(133)   The same system should also be
provided for in this Regulation. However, to encourage Member States to enhance
the health status of their aquatic populations, some adjustments and added
flexibility should be introduced. 
(134)   In order to ensure movement
control for aquatic animals, the power to adopt acts in accordance with Article
290 of the Treaty on the Functioning of the European Union should be delegated
to the Commission, concerning the disease preventive measures applicable to transport,
specific rules for movements of certain categories of aquatic animals for
different purposes, specific requirements or derogations for certain types of
movements, such as movement for scientific purposes and additional requirements
for movement of wild aquatic animals.
(135)   In order to ensure the possibility
of temporary derogations and specific requirements for movements of aquatic
animals, where the movement rules laid down in this Regulation are not
sufficient or appropriate to limit the spread of a certain listed disease,
implementing powers should be conferred on the Commission for laying down special
movement rules or derogations for a limited period of time.
(136)   Union aquaculture production
is extremely diverse as regards species and production systems and this
diversification is rapidly increasing. This may warrant that national measures concerning
diseases other than those that are regarded as listed diseases in accordance
with this Regulation are taken at Member State level. However, such national
measures should be justified, necessary and proportionate to the goals to be
achieved. Furthermore, they should not affect movements between Member States unless
it is necessary in order to prevent the introduction of or to control the spread
of disease. National measures affecting trade between Member States should be
approved and regularly reviewed at Union level.
(137)   Currently, listed diseases
concern animal species other than those defined as terrestrial and aquatic by
this Regulation, such as reptiles, amphibians, insects and others only to a
very limited extent. It is therefore not appropriate to require that all the
provisions of this Regulation apply to those animals. However, if a disease
which concerns species other than terrestrial and aquatic should become listed,
the relevant animal health requirements of this Regulation should apply to those
species to ensure that adequate and proportionate disease prevention and
control measures may be taken.
(138)   In order to ensure the
possibility of laying down movement rules for those animals that are not
defined as terrestrial and aquatic animals by this Regulation, and germinal
products and products of animal origin from them, when a risk so warrants, the
power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission, concerning
the registration and approval of establishments, record keeping and registers,
identification and registration and traceability movement requirements, animal
health certification and self-declaration and movement notification obligations
for animals, germinal products and products of animal origin of those species. 
(139)   When necessary to ensure
uniform conditions for the implementation of the animal health requirements for
those other animal species and germinal products and products of animal origin
from them, implementing powers should be conferred on the Commission to lay
down detailed rules concerning those requirements. 
(140)   To prevent the introduction
of listed diseases and emerging diseases into the Union, it is necessary to
have in place efficient rules on the entry into the Union of animals, germinal
products and products of animal origin that may transmit such diseases. 
(141)   The requirements for entry
of animals and products into the Union should mirror the requirements for
movements of animal and products of the same category, species and intended use
within the Union.
(142)   To ensure that animals,
germinal products and products of animal origin from third countries or
territories comply with the animal health requirements that provide guarantees
that are equivalent to those provided for in Union legislation, it is essential
that they are subject to appropriate controls by the competent authority of the
third countries or territories exporting to the Union. Where relevant, the
health status of a third country or territory of origin should be verified
prior to accepting the entry of such animals, germinal products and products of
animal origin. Consequently, only third countries and territories which can
demonstrate that they meet the animal health standards for entry of the animals
and products into the Union should be eligible to export them to the Union and
be listed for that purpose. 
(143)   For some species and
categories of animals, germinal products and products of animal origin the
Union lists of third countries and territories from which entry into the Union
is permitted have not been established in Union acts adopted prior to the date
of adoption of this Regulation. In those cases and pending the adoption of
rules pursuant to Regulation, Member States should be permitted to determine
from which countries and territories those animals, germinal products and
products of animal origin may be permitted to enter their territory. In so determining,
Member States should take into account the criteria laid down in this
Regulation for the Union lists of third countries and territories.
(144)   To ensure that the animal
health requirements for the entry into the Union provided for in this
Regulation are complied with and are in line with the principles of the OIE
Animal Health Codes, all animals, germinal products and products of animal
origin entering the Union should be accompanied by an animal health certificate
issued by the competent authority of the third country or territory of origin
confirming that all the animal health requirements for entry into the Union are
complied with. However, deviation from this rule for commodities which pose a
low animal health risk should be permitted. 
(145)   Animal health certificates may
stand on their own, but certification is often required in Union legislation for
other purposes, for example to certify that public health or animal welfare
requirements of animals or products have been complied with. This has to be
taken into account. In order to minimise administrative burdens and costs those
animal health certificates should also be permitted to include information
required under other Union food and feed safety legislation.
(146)   Diseases may be spread by
means other than animals, germinal products, products of animal origin and
animal by-products and derived products. For instance, vehicles, transport
containers, hay, straw, plant products, materials that may have been in contact
with infected animals and equipment may also spread disease. Where necessary,
measures should be taken to prevent these routes of disease transmission by
those means. 
(147)   In order to ensure the
appropriate level of detail for the requirements for entry into the Union, the
power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission, to
supplement and amend the criteria for the listing of third countries and
territories, criteria for the suspension or withdrawal from that list, supplementing
the rules for the approval of establishments in third countries and territories
and derogations, animal health requirements for the entry into the Union of
consignments from third countries and territories, contents of animal health
certificates, and the animal health requirements for disease agents, other
materials, means of transport and equipment, which may transmit animal
diseases.
(148)   In order to ensure uniform
conditions for the implementation of the animal health requirements for the entry
into the Union of consignments of animals, germinal products and products of
animal origin, implementing powers should be conferred on the Commission to lay
down rules on, inter alia the list of third countries and territories from which
the entry into the Union of animals, germinal products and products of animal
origin is allowed and model animal health certificates.
(149)   Past experience has shown that
when an outbreak of a serious disease occurs in Member States or in third
countries or territories from which animals or products enter the Union,
disease prevention and control measures have to be taken immediately to limit
its introduction and spread. Such an emergency may involve listed diseases,
emerging diseases or other animal health hazards. In that context, it should be
made clear which sets of disease prevention and control measures laid down in
this Regulation may be used in the event of the occurrence of a listed or
emerging disease or hazard. In all these cases it is essential that measures
can be taken at very short notice and without any delay. As such measures would
restrict movement within or into the Union they should be implemented at Union
level whenever possible. 
(150)   In order to ensure an
effective and quick reaction to emerging risks, implementing powers should be
conferred on the Commission to lay down emergency measures.
(151)   The Commission should adopt
immediately applicable implementing acts in duly justified cases relating to inter
alia the listing of diseases and species, the listed diseases that are to be
subject to the sets of disease prevention and control rules, the stocking,
supply, storage, delivery and other procedures of Union antigen, vaccine and
diagnostic reagent banks, the laying down of special disease control measures
and derogations for a limited period of time, the special movement rules for
terrestrial and aquatic animals for a limited period of time, the emergency
measures, and the listing of third countries and territories for entry into the
Union.
(152)   This Regulation lays down
general and specific rules for the prevention and control of transmissible animal
diseases and ensures a harmonised approach to animal health across the Union. In
some areas, such as general responsibilities for animal health, notification,
surveillance, registration and approval or traceability, the Member States should
be allowed or encouraged to apply additional or more stringent national measures.
However, such national measures should be permitted only if they do not
compromise the animal health objectives of this Regulation, and if they are not
in contradiction with the rules laid down therein and provided that they do not
hinder movements of animals and products between Member States, unless it is
necessary in order to prevent the introduction of or to control the spread of disease.

(153)   The national measures
referred to in recital 152 should be subject to a simplified notification
procedure in order to reduce the administrative burden. Experience has shown
that the general notification procedure laid down in Directive 98/34/EC of the
European Parliament and of the Council of 22 June 1998 laying down a procedure
for the provision of information in the field of technical standards and
regulations and of rules on Information Society services[33],
has been an important tool for guiding and improving the quality of national
technical regulations – in terms of increased transparency, readibility and
effectiveness, in non-harmonised or partly harmonised areas. It is therefore
appropriate that this general notification procedure laid down in Directive
98/34/EC applies.
(154)   Currently, Union rules on
animal health are laid down in the following acts of the European Parliament
and of the Council and in subsequent Commission acts adopted pursuant to them: 
–              
Council Directive 64/432/EEC of 26 June 1964 on
animal health problems affecting intra-Community trade in bovine animals and
swine[34], 
–              
Council Directive 77/391/EEC of 17 May 1977
introducing Community measures for the eradication of brucellosis, tuberculosis
and leucosis in cattle[35], 
–              
Council Directive 78/52/EEC of 13 December 1977
establishing the Community criteria for national plans for the accelerated
eradication of brucellosis, tuberculosis and enzootic leukosis in cattle[36],

–              
Council Directive 88/407/EEC of 14 June 1988
laying down the animal health requirements applicable to intra-Community trade
in and imports of semen of domestic animals of the bovine species[37],

–              
Council Directive 80/1095/EEC of 11 November
1980 laying down conditions designed to render and keep the territory of the
Community free from classical swine fever[38], 
–              
Council Directive 82/894/EEC of 21 December 1982
on the notification of animal diseases within the Community[39],

–              
Council Directive 89/556/EEC of 25 September
1989 on animal health conditions governing intra-Community trade in and
importation from third countries of embryos of domestic animals of the bovine
species[40], 
–              
Council Directive 90/429/EEC of 26 June 1990
laying down the animal health requirements applicable to intra- Community trade
in and imports of semen of domestic animals of the porcine species[41],
–              
Council Directive 91/68/EEC of 28 January 1991
on animal health conditions governing intra-Community trade in ovine and
caprine animals[42], 
–              
Council Decision 91/666/ EEC of 11 December 1991
establishing Community reserves of foot-and-mouth disease vaccines[43],

–              
Council Directive 92/35/EEC of 29 April 1992
laying down control rules and measures to combat African horse sickness[44],

–              
Council Directive 92/65/EEC of 13 July 1992
laying down animal health requirements governing trade in and imports into the
Community of animals, semen, ova and embryos not subject to animal health
requirements laid down in specific Community rules referred to in Annex A (I)
to Directive 90/425/EEC[45], 
–              
Council Directive 92/66/EEC of 14 July 1992
introducing Community measures for the control of Newcastle disease[46],

–              
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 diseases
and specific measures relating to swine vesicular disease[48],

–              
Council Decision 95/410/EC of 22 June 1995
laying down the rules for testing by sampling in the establishment of origin of
poultry for slaughter intended for Finland and Sweden[49],
–              
Council Directive 2000/75/EC of 20 November 2000
laying down specific provisions for the control and eradication of bluetongue[50],

–              
Council Decision 2000/258/EC of 20 March 2000
designating a specific institute responsible for establishing the criteria
necessary for standardising the serological tests to monitor the effectiveness
of rabies vaccines[51],
–              
Regulation (EC) No 1760/2000 of the European
Parliament and of the Council of 17 July 2000 establishing a system for the
identification and registration of bovine animals and regarding the labelling
of beef and beef products and repealing Council Regulation (EC) No 820/97[52],

–              
Council Directive 2001/89/EC of 23 October 2001
on Community measures for the control of classical swine fever[53],

–              
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], 
–              
Council Directive 2002/99/EC of 16 December 2002
laying down the animal health rules governing the production, processing,
distribution and introduction of products of animal origin for human
consumption[55], 
–              
Council Directive 2003/85/EC of 29 of September
2003 on Community measures for the control of foot-and-mouth disease repealing
Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending
Directive 92/46/EEC[56], 
–              
Regulation (EU) No XXX/XXXX of the European
Parliament and of the Council of …. on the non-commercial movement of pet
animals and repealing Regulation (EC) No 998/2003 [Publication office] [57],

–              
Council Regulation (EC) No 21/2004 of 17
December 2003 establishing a system for the identification and registration of
ovine and caprine animals and amending Regulation (EC) No 1782/2003 and
Directives 92/102/EEC and 64/432/EEC/EEC[58], 
–              
Council Directive 2004/68/EC of 26 April 2004
laying down animal health rules for the importation into and transit through
the Community of certain live ungulate animals, amending Directives 90/426/EEC
and 92/65/EEC and repealing Directive 72/462/EEC[59],

–              
Council Directive 2009/156/EC of 30 November
2009 on animal health conditions governing the movement and importation from
third countries of equidae[60], 
–              
Council Directive 2005/94/EC of 20 December 2005
on Community measures for the control of avian influenza and repealing
Directive 92/40/EEC[61], 
–              
Council Directive 2006/88/EC of 24 October 2006
on animal health requirements for aquaculture animals and products thereof, and
on the prevention and control of certain diseases in aquatic animals[62],

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

–              
Council Directive 2009/158/EC of 30 November
2009 on animal health conditions governing intra-Community trade in, and
imports from third countries of, poultry and hatching eggs[64].

(155)   The rules laid down in the legislative
acts referred to in recital 154 are to be replaced by this Regulation and by subsequent
Commission acts to be adopted pursuant to this Regulation. Accordingly, those
legislative acts should be repealed. However, to ensure legal clarity and avoid
a legal vacuum, the repeal should only take effect when the relevant delegated
and implementing acts are adopted pursuant to this Regulation. It is therefore
necessary to provide the Commission with the empowerment to determine the dates
when the repeal of those legislative acts should take effect. 
(156)   The following Council acts
in the area of animal health are obsolete and should be expressly repealed in
the interests of clarity of Union legislation: Council Decision 78/642/EEC of
25 July 1978 on health protection measures in respect of the Republic of
Botswana[65]; Council Directive
79/110/EEC of 24 January 1979 authorizing the Italian Republic to postpone the
notification and implementation of its national plans for the accelerated
eradication of brucellosis and tuberculosis in cattle[66];
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 cattle[67];
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 prevention[68]; Council Directive
90/423/EEC of 26 June 1990 amending Directive 85/511/EEC introducing Community
measures for the control of foot-and-mouth disease[69];
Council Decision 90/678/EEC of 13 December 1990 recognizing certain parts of
the territory of the Community as being either officially swine fever free or
swine fever free[70].
(157)   The requirements of this
Regulation should not apply until all the delegated and implementing acts to be
adopted by the Commission pursuant to this Regulation, have applied. It is appropriate
to provide for at least 36 months to elapse between the date of entry into
force of this Regulation and the date of application of the new rules, to allow
the operators affected sufficient time to adapt.
(158)   In order to ensure legal
certainty as regards the application of rules for identification and
registration of animals, disease control measures for certain zoonoses and
non-commercial movements of pet animals, the power to adopt acts in accordance
with Article 290 of the Treaty on the Functioning of the European Union should
be delegated to the Commission in respect of the date on which Regulations (EC)
No 1760/2000, (EU) No XXX/XXX [Ex-998/2003] and (EC) No 21/2004 and Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC,
2003/85/EC, 2005/94/EC and 2008/71/EC cease to apply.
(159)   The implementing powers provided
for in this Regulation should be exercised in accordance with Regulation (EU) No 182/2011
of the European Parliament and of the Council of 16 February 2011 laying down
the rules and general principles concerning mechanisms for control by the
Member States of the Commission's exercise of implementing powers[71].
(160)   It is of particular
importance that the Commission carry out appropriate consultations during its
preparatory work, including at expert level. The Commission, when preparing and
drawing up delegated acts, should ensure a simultaneous, timely and appropriate
transmission of relevant documents to the European Parliament and to the
Council.
(161)   This Regulation should not
create a disproportionate administrative burden or economic impact for small
and medium sized enterprises. Under this Regulation, based on consultation with
stakeholders, the special situation of small and medium sized enterprises has
been taken into account. A potential universal derogation from
the requirements of this Regulation for such enterprises has not been
considered, in view of the public policy objectives to protect animal health
and public health. However, a number of derogations for such enterprises should
be provided for in relation to the different requirements of this Regulation,
taking into account the risks involved. 
(162)   The objectives of this
Regulation, namely to lay down animal health rules for animals, germinal
products, products of animal origin, animal by-products and derived products to
the extent that they are not covered by specific rules in other Union
legislation and other material that can be involved in the spread of transmissible
animal diseases, cannot be achieved sufficiently by the Member States, and can
be more efficiently achieved at Union level through a common and coordinated
legal framework for animal health. This Regulation is therefore in line with
the principle of subsidiarity as set out in Article 5(3) of the Treaty on
European Union. In accordance with the principle of proportionality, as set out
in that Article, this Regulation does not go beyond what is necessary in order
to achieve those objectives,
HAVE ADOPTED THIS REGULATION:
PART I 
GENERAL RULES
Chapter 1
Subject matter, scope and definitions 
Article 1
Subject matter
1.           This Regulation lays down rules
for the prevention and control of animal diseases, which are transmissible to animals
or to humans.
Those rules provide for: 
(a)     the prioritisation and categorisation
of diseases of Union concern and for establishing responsibilities for animal
health in Part I;
(b)     the early detection, notification and
reporting of diseases, surveillance, eradication programmes and disease-free
status in Part II;
(c)     disease awareness, preparedness and
control in Part III;
(d)     the registration and approval of
establishments and transporters, movements and traceability of consignments of
animals, germinal products and products of animal origin within the Union in
Part IV;
(e)     the entry of consignments of animals,
germinal products, and products of animal origin into the Union and the export
of such consignments from the Union in Part V;
(f)      the emergency measures to be taken in
the event of a disease emergency situation in Part VI. 
2.           The rules referred to in paragraph
1:
(a)     ensure
(i)      a sustainable agricultural and
aquaculture production in the Union; 
(ii)      the effective functioning of the
internal market; 
(iii)     a reduction in the adverse effects on
the environment of: 
–              
certain diseases; 
–              
the measures taken to prevent and control
diseases;
(b)     take into account 
(i)      the relationship between animal
health and: 
–              
public health;
–              
the environment as well as the impacts of
climate change;
–              
food and feed safety;
–              
animal welfare;
–              
food security;
(ii)      the economic, social, cultural and environmental
consequences arising from the application of disease control and prevention
measures.
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 apply to
transmissible diseases, including zoonoses, without prejudice to the rules laid
down in: 
(a)     Decision No 2119/98/EC; 
(b)     Regulation (EC) No 999/2001; 
(c)     Directive 2003/99/EC;
(d)     Regulation (EC) No. 2160/2003.
Article 3
Scope of Part IV on registration, approval, traceability and movements
1.           Title I of Part IV shall apply
to:
(a)     terrestrial
animals, and animals that are not terrestrial animals but which may
transmit diseases affecting terrestrial animals;
(b)     germinal products from terrestrial
animals;
(c)     products of animal origin from
terrestrial animals.
2.           Title II of Part IV shall apply
to:
(a)     aquatic animals, and animals that are
not aquatic animals but which may transmit diseases affecting aquatic animals; 
(b)     products of animal origin from aquatic
animals.
3.           Title III of Part IV shall apply
to: 
(a)     animals other than those defined as terrestrial
animals and aquatic animals in Article 4(1)(4);
(b)     germinal products and products of
animal origin from the other animals referred to in point (a).
4.           Chapters 1 and 3 of Title I and
Chapters 1 and 2 of Title II of Part IV shall not apply to pet animals.
Article 4
Definitions
1.           For the purpose of this
Regulation, the following definitions shall apply:
(1)         
'animals' means vertebrate and invertebrate
animals;
(2)         
'terrestrial animals' means birds, terrestrial
mammals, bees and bumble bees;
(3)         
'aquatic animals' means animals of the following
species, at all life stages, including eggs, sperm and gametes:
(i)      fish belonging to the superclass
Agnatha and to the classes Chondrichthyes, Sarcopterygii and Actinopterygii;
(ii)      aquatic molluscs belonging to the phylum
Mollusca;
(iii)     aquatic crustaceans belonging 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 which
are subsequently temporarily kept awaiting slaughter without being fed; 
(7)         
'aquaculture animals' means aquatic animals
subject to aquaculture; 
(8)         
'wild animals' means animals which are not kept
animals;
(9)         
'poultry' means birds that are reared or kept in
captivity for: 
(a)     the production of: 
(i)      meat;
(ii)      eggs for consumption;
(iii)     other products; 
(b)     restocking supplies of game birds;
(c)     the purposes of breeding of birds used
for the types of production referred to in point (a); 
(10)     
'captive birds' means any birds other than
poultry that are kept in captivity for any reason other than those referred to
in point (9) including those that are kept for shows, races, exhibitions,
competitions, breeding or selling;
(11)     
'pet animal' means an animal of the species
listed in Annex I, which:
(a)     is kept in a household, or in the case
of aquatic animals, kept in non-commercial ornamental aquaria; 
(b)     when moved, accompanies for the
purpose of a non-commercial movement the pet keeper, or a natural person acting
on behalf of and in agreement with the pet keeper, and which remains during
such non-commercial movement under the responsibility of the pet keeper or such
person;
(12)     
'pet keeper' means a natural person keeping a
pet animal;
(13)     
'non-commercial movement' means any movement of
pet animals which does not involve or aim, directly or indirectly, at a
financial gain or a transfer of ownership;
(14)     
'disease' means the occurrence of infections and
infestations in animals, with or without clinical or pathological
manifestations, caused by one or more disease agents transmissible to animals
or to humans;
(15)     
'listed diseases' mean diseases listed in
accordance with Article 5(2);
(16)     
'emerging disease' means a disease other than a
listed disease which has the potential to meet the criteria for listed diseases
provided for in Article 6(1)(a) due to:
(a)     a new disease resulting from the
evolution or change of an existing disease agent; 
(b)     a known disease spreading to a new
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
disease referred to in Article 6(1)(a); 
(18)     
'listed species' means animal species or group
of animal species listed in accordance with Article 7(2), or, in the case of
emerging diseases, animal species or groups of animal species, which meet the
criteria for listed species laid down in Article 7(2);
(19)     
'hazard' means a disease agent in, or a
condition of, an animal or product with the potential to have an adverse health
effect in humans or animals;
(20)     
'risk' means the likelihood of the occurrence
and the likely magnitude of the biological and economic consequences of an
adverse effect on animal or public health;
(21)     
'biosecurity' means the sum of management and
physical measures designed to reduce the risk of the introduction, development
and spread of diseases to, from and within: 
(a)     an animal population, or 
(b)     an establishment, zone, compartment,
means of transport or any other facilities, premises or location; 
(22)     
'operator' means a natural or legal person,
having animals and products under their responsibility, including animal
keepers and transporters, but excluding pet keepers and veterinarians;
(23)     
'animal professional' means a natural or legal
person, with an occupational relationship with animals or products, other than
operators or veterinarians;
(24)     
'establishment' means any premises, structure,
or any environment, in which animals or germinal products are kept, except for:
(a)     households keeping pet animals; 
(b)     non-commercial aquaria keeping aquatic
animals; 
(c)     veterinary practices or clinics;
(25)     
'germinal products' means: 
(a)     sperm, semen, oocytes and embryos
intended for artificial reproduction; 
(b)     hatching eggs;
(26)     
'products of animal origin' means: 
(a)     food of animal origin, including honey
and blood;
(b)     live bivalve molluscs, live
echinoderms, live tunicates and live marine gastropods intended for human
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 obtained from animals
which are not intended for human consumption, excluding germinal products; 
(28)     
'derived products’ means
products obtained from one or more treatments, transformations or steps of the processing
of animal by-products;
(29)     
'products' means: 
(a)     germinal products; 
(b)     products of animal origin; 
(c)     animal by-products and derived
products;
(30)     
'official control' means an
official control as defined in point (1) of Article 2 of Regulation (EU)
XXX/XXX [Publication office – Number to be added: on official controls and
other official activities.];
(31)     
'health status' means the disease status as
regards all the listed diseases for a particular listed species with respect
to: 
(a)     an animal;
(b)     the animals within:
(i)      an establishment; 
(ii)      a compartment; 
(iii)     a zone; 
(iv)     a Member State;
(v)     a third country or territory;
(32)     
'zone' means:
(a)     for terrestrial animals a clearly
defined part of a Member State, third country or territory containing an animal
subpopulation with a distinct health status with respect to a specific disease
or specific diseases subject to appropriate surveillance, disease control and
biosecurity measures; 
(b)     for aquatic animals a contiguous
hydrological system with a distinct health status with respect to a specific disease
or specific diseases that forms an area that is referred to in one of the
following:
(i)      an entire water catchment from the
source of a waterway to the estuary or lake; 
(ii)      more than one water catchment; 
(iii)     part of a water catchment from the
source of a waterway to a barrier that prevents the introduction of a specific
disease or diseases; 
(iv)     part of a coastal area with a precise
geographical delimitation; 
(v)     an estuary with a precise geographical
delimitation;
(33)      'water catchment' means an area or basin of land bounded by natural
features such as hills or mountains, into which all run-off water flows;
(34)     
'compartment' means an animal subpopulation contained
in one or more establishments and in the case of aquatic animals in one or more
aquaculture establishments, under a common biosecurity management system with a
distinct health status with respect to a specific disease or specific diseases
subject to appropriate surveillance, disease control and biosecurity measures;
(35)     
'quarantine' means the maintaining of animals in
isolation under the control of the competent authority with no direct or
indirect contact with other animals, for the purposes of ensuring that there is
no spread of diseases while the animals are undergoing observation for a
specified length of time and, if appropriate, testing and treatment;
(36)     
'epidemiological unit' means a group of animals
with the same likelihood of exposure to a disease agent;
(37)     
'outbreak' means one or more cases in an
establishment, household or other place where animals are kept or located;
(38)     
'case' means the official confirmation of the presence
of a listed disease or an emerging disease in a live or dead animal;
(39)     
'restricted zone' means a zone in which
restrictions on the movements of certain animals or products and other disease
control measures are applied, with a view to preventing the spread of a
particular disease into areas where no restrictions are applied; a restricted
zone may, when relevant, include protection and surveillance zones;
(40)     
'protection zone' means a zone with one or more
disease cases which is established after the official confirmation of an
outbreak, and where disease control measures are applied in order to prevent
the spread of the disease from that zone; 
(41)     
'surveillance zone' means a zone, established
after the official confirmation of an outbreak and which is situated around the
protection zone, and where disease control measures are applied in order to
prevent the spread of the disease from that zone and the protection zone; 
(42)     
'hatching eggs' means eggs, laid by poultry, intended
for incubation;
(43)     
'ungulates' means the animals listed in Annex II;

(44)     
'germinal product establishment' means: 
(a)     an establishment for the collection, production,
processing and storage of germinal products; 
(b)     a hatchery;
(45)     
'hatchery' means an establishment which
collects, stores, incubates and hatches eggs for the supply of:
(a)     eggs for incubation;
(b)     day-old chicks or hatchlings of other
species;
(46)     
'transporter' means an operator transporting
animals on its own account, or for a third party;
(47)      'confined establishment' means any permanent, geographically limited
establishment, created on a voluntary basis, and approved for the purpose of
movements, where the animals are: 
(a)          
kept or bred for the purposes of exhibitions,
education, the conservation of species or research;
(b)         
confined and separated from the surrounding
environment;
(c)          
subject to strict animal health surveillance and
biosecurity measures;
(48)     
'assembly operation' means the assembling of
kept terrestrial animals from more than one establishments for a period shorter
than the required residency period for that species of animals;
(49)     
'residency period' means the minimum period an
animal is required to stay at an establishment prior to being moved from that
establishment;
(50)     
'IMSOC' means the computerised information
management system provided for by Article 130(1) of Regulation (EU) No. XXX/XXX
[Publication office: Number to be added -on official controls and
other official activities];
(51)     
'disease control aquatic food establishment'
means a food business approved in accordance with the following provisions: 
(a)     Article 4 of Regulation (EC) No
853/2004, for processing aquaculture animals for food purposes; 
(b)     Article 177 of this Regulation for the
slaughter of aquatic animals for disease control purposes in accordance with
Title II of Part III.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning amendments to
the list of:
(a)     pet animals set out in Annex I;
(b)     ungulates set out in Annex II. 
Chapter 2
Listed diseases and emerging diseases and listed species
Article 5
Listing of diseases
1.           The disease specific rules for
the prevention and control of diseases provided for in this Regulation shall
apply to: 
(a)     listed diseases; 
(b)     emerging diseases.
2.           The Commission shall, by means of
implementing acts, establish a list of listed diseases, as referred to in
paragraph 1(a).
That list shall comprise diseases which meet
with the conditions laid down in the following points (a) and (b) of this
paragraph, taking into account the criteria for listing diseases laid down in
Article 6:
(a)     diseases which are likely to have a
significant impact on at least one of the following:
(i)      public health; 
(ii)      agricultural or aquaculture
production or related sectors of the economy; 
(iii)     the society in Member States and
where appropriate in third countries or territories; 
(iv)     the environment;
(b)     diseases for which risk mitigating
measures are available, or can be developed and are proportionate to the risks
posed by such diseases.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
On duly justified imperative grounds of urgency
relating to a disease representing an emerging risk of highly significant
impact the Commission shall adopt immediately applicable implementing acts in
accordance with the procedure referred to in Article 255(3).
Article 6
Criteria for listing diseases 
1.           The Commission shall take account
of the following criteria in determining whether a disease meets the conditions
to be listed in accordance with Article 5(2): 
(a)     the disease profile, which shall
comprise the following:
(i)      the animal species concerned by the
disease;
(ii)      the morbidity and mortality rates of
the disease in animal populations;
(iii)     the zoonotic character of the
disease;
(iv)     the capacity to develop resistance to
treatments; 
(v)     the persistence of the disease in an
animal population or in the environment;
(vi)     the routes and speed of transmission
of the disease between animals and when relevant between animals and humans;
(vii)    the absence or presence and
distribution of the disease in the Union, and, where the disease is not present
in the Union, the risk of its introduction into the Union;
(viii)   the existence of diagnostic and
disease control tools;
(b)     the impact of the disease on: 
(i)      agricultural and aquaculture
production and other parts of the economy:
–              
the level of presence of the disease in the
Union;
–              
the loss of production due to the disease;
–              
other losses;
(ii)      human health:
–              
transmissibility between animals and humans; 
–              
transmissibility between humans;
–              
the severity of human forms of the disease;
–              
the availability of effective prevention or
medical treatment in humans;
(iii)     animal welfare;
(iv)     biodiversity and environmental pollution;
(c)     its potential to generate a crisis
situation and its potential use in bioterrorism;
(d)     the feasibility, availability and
effectiveness of the following disease prevention and control measures:
(i)      diagnostic tools and capacities;
(ii)      vaccination;
(iii)     medical treatments;
(iv)     biosecurity measures;
(v)     restrictions on the movement of
animals and products;
(vi)     culling and disposal of animals;
(e)     the impact of disease prevention and
control measures as regards to:
(i)      the direct and indirect costs for the
affected sectors and the economy as a whole;
(ii)      their societal acceptance;
(iii)     the welfare of affected
subpopulations of kept and wild animals; 
(iv)     the environment and biodiversity.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning amendments to
the criteria provided for in paragraph 1 of this Article to take account of
technical and scientific progress and the developments of relevant
international standards.
Article 7
Listing of species
1.           The disease specific rules for
listed diseases provided for in this Regulation and the rules adopted pursuant
to this Regulation shall apply to listed species.
2.           The Commission shall, by means of
implementing acts, establish a list of species, as referred to in paragraph 1. 
That list shall comprise those animal species
or groups of animal species, which pose a considerable risk for the spread of specific
listed diseases, taking into account the following criteria:
(a)     the susceptibility of the animal
population at risk;
(b)     the duration of the incubation and
infective period for the animals;
(c)     the capability of those animals to
carry those specific diseases.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
On duly justified imperative grounds of urgency
relating to a disease representing an emerging risk of highly significant
impact the Commission shall adopt immediately applicable implementing acts in
accordance with the procedure referred to in Article 255(3).
Article 8
Application of disease prevention and control rules to listed diseases
1.           The Commission shall, by means of
implementing acts, determine the application of the disease prevention and
control rules referred to in the following points to listed diseases:
(a)     listed diseases subject to rules on:
(i)      disease awareness and preparedness
provided for in Title I of Part III and disease control measures provided for in
Chapter 1 of Title II of Part III;
(ii)      compartmentalisation provided for in
Article 37(1);
(b)     listed diseases subject to the disease
prevention and control rules on:
(i)      compulsory eradication programmes
provided for in Article 30(1);
(ii)      disease-free Member States and zones
provided for in Article 36;
(iii)     compartmentalisation provided for in
Article 37(2);
(iv)     disease control measures provided for
in Chapter 2 of Title II of Part III;
(c)     listed diseases subject to the disease
prevention and control rules on:
(i)      voluntary eradication provided for in
Article 30(2);
(ii)      disease-free Member States and zones
provided for in Article 36;
(iii)     compartmentalisation provided for in
Article 37(2);
(iv)     disease control measures provided for
in Chapter 2 of Title II of Part III;
(d)     listed diseases subject to the disease
prevention and control rules on:
(i)      movement within the Union provided
for in Chapters 3 to 7 of Title I and Chapters 2, 3 and 4 of Title II of Part
IV;
(ii)      entry into the Union and export from
the Union provided for in Part V;
(e)     listed diseases subject to the disease
prevention and control rules on: 
(i)      notification and reporting provided
for in Chapter 1 of Part II;
(ii)      surveillance provided for in Chapter
2 of Part II.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
On duly justified imperative grounds of urgency
relating to a disease representing an emerging risk of highly significant
impact the Commission shall adopt immediately applicable implementing acts in accordance
with the procedure referred to in Article 255(3).
2.           The Commission shall take into
account the following criteria when adopting implementing acts provided for in
paragraph 1:
(a)     the level of impact of the disease on
animal and public health, animal welfare and the economy; 
(b)     the prevalence, incidence and
distribution of the disease in the Union; 
(c)     the availability, feasibility and
effectiveness of the different sets of disease prevention and control measures
provided for in this Regulation with respect to the disease.
Chapter
3
Responsibilities for animal health
Section 1
Operators, animal professionals and pet keepers
Article 9
Responsibilities for animal health and biosecurity measures
1.           Operators, animal professionals
and pet keepers shall:
(a)     be responsible for the health of kept
animals and products 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
multiplication within and spread between and from such kept animals and products
under their responsibility of diseases, except where that is specifically
authorised for scientific purposes, as appropriate for: 
(i)      the categories and species of kept
animals and products; 
(ii)      the type of production.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning biosecurity
measures supplementing the rules laid down in paragraph 1(b) of this Article.
Article 10
Basic knowledge of animal health
1.           Operators and animal
professionals shall acquire knowledge of:
(a)     animal
diseases, including those that are transmissible to humans; 
(b)     biosecurity
principles; 
(c)     the interaction between animal health,
animal welfare and human health. 
2.           The content and the level of
knowledge required in accordance with paragraph 1 shall depend on:
(a)     the categories and species of kept
animals or products under 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 experience or training; 
(b)     existing programmes in agricultural or
aquaculture sectors that are relevant for animal health; 
(c)     formal education.
Section 2
Veterinarians and aquatic animal health professionals 
Article 11
Responsibilities of veterinarians and aquatic animal health professionals 
1.           Veterinarians shall in the course
of their activities which fall within the scope of this Regulation:
(a)     take all appropriate measures to
prevent the introduction, development and spread of diseases;
(b)     ensure the early detection of diseases
by carrying out proper diagnosis and differential diagnosis to rule out or confirm
a disease before symptomatic treatment is commenced;
(c)     play an active role in: 
(i)      raising animal health awareness; 
(ii)      disease prevention; 
(iii)     the early detection and rapid
response to diseases. 
(d)     cooperate with the competent
authority, operators, animal professionals and pet keepers in the application of
the disease prevention and control measures provided for in this Regulation.
2.           Aquatic animal health
professionals may undertake activities attributed to veterinarians under this
Regulation in relation to aquatic animals provided that they are authorised to
do so under national legislation. In that event, paragraph 1 shall apply to
those aquatic animal health professionals.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the qualifications
of veterinarians and aquatic animal health professionals undertaking activities
which fall within the scope of this Regulation.
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, equipment,
financial resources and an effective organisation covering the whole territory
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 diseases and
emerging diseases;
(c)     sufficiently trained veterinarians
involved in performing the activities referred to in Article 11 which fall
within the scope of this Regulation.
2.           Member States shall support
operators and animal professionals in acquiring, maintaining and developing the
basic knowledge of animal health provided for in Article 10 through relevant programmes
in agricultural or aquaculture sectors or formal education.
Article 13
Competent authority's delegation of other official activities
1.           The
competent authority may delegate one or more of the following activities to
veterinarians: 
(a)     activities
concerning notification and reporting as provided for in Chapter 1 of Part II and
surveillance as provided for in Chapter 2 of that Part;
(b)     activities related to: 
(i)      disease awareness, preparedness and
control as provided for in Part III;
(ii)      registration, approval, traceability
and movements as provided for in Part IV;
(iii)     emergency measures as provided for
in Part VI.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253, concerning: 
(a)     the circumstances and conditions for
delegating the activities provided for in paragraph 1;
(b)     which other activities may be
delegated to veterinarians in addition to those provided for in paragraph 1 of
this Article, and under which circumstances and under which conditions; 
(c)     minimum requirements for the training
of veterinarians provided for in Article 12(1)(c).
The Commission shall take account of the nature
of those tasks and the international obligations of the Union and the Member
States, when adopting those delegated acts. 
Article 14
Public information
Where there are reasonable grounds to
suspect that animals or products may present a risk, the competent authority
shall take appropriate steps to inform the general public of the nature of the
risk and the measures which are taken or about to be taken to prevent or
control that risk, taking into account the nature, seriousness and extent of
that risk and the public interest in being informed.
Section 4
Laboratories, facilities and other natural and legal persons handling disease
agents, vaccines and other biological products
Article 15
Obligations of laboratories, facilities and others handling disease agents,
vaccines and other biological products
1.           Laboratories, facilities and
other natural or legal persons handling disease agents for the purpose of
research, education, diagnosis or the production of vaccines and other biological
products shall, whilst taking into account international standards where they exist:
(a)     take appropriate biosecurity,
biosafety and bio-containment measures to prevent the escape of the disease
agents and their subsequent contact with animals outside the laboratory or other
facility handling disease agents for the purpose of research; 
(b)     ensure that the movement of disease
agents, vaccines and other biological products between laboratories or other
facilities does not give rise to a risk of the spread of listed and emerging
diseases.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the safety
measures for the laboratories, facilities and other natural or legal persons handling
the disease agents, vaccines and other biological products in relation to: 
(a)     biosecurity, biosafety and
bio-containment measures;
(b)     movement requirements for disease
agents, vaccines and other biological products.
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 abnormal mortalities
and other serious disease signs or significant decreased production rates with
an undetermined cause in animals for further investigation, including sampling
for laboratory examination when the situation so warrants. 
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 adopt delegated acts in accordance with Article 253 concerning:
(a)     criteria to determine whether the
circumstances requiring notification described in paragraph 1(b) of this
Article occur;
(b)     detailed rules for the further
investigation provided for in paragraph 1(b) of this Article.
Article 17
Union notification 
1.           Member States shall immediately
notify the Commission and the other Member States of any outbreaks of listed
diseases referred to in Article 8(1)(e) for which an immediate notification is required
to ensure the timely implementation of necessary risk management measures,
taking into account the disease profile.
2.           The notification provided for in
paragraph 1 shall contain the following information on the outbreak: 
(a)     the disease agent and, where relevant,
the subtype;
(b)     the dates of the suspicion and
confirmation of the outbreak; 
(c)     the location of the outbreak; 
(d)     any related outbreaks;
(e)     the animals affected by the outbreak;
(f)      any disease control measures taken in
relation to the outbreak;
(g)     the possible or known origin of the
listed disease;
(h)     the diagnostic methods used. 
3.           The Commission shall by means of
implementing acts establish which of the listed diseases referred to in in
Article 8(1)(e) shall be subject to immediate notification by the Member States
in accordance with paragraph 1 of this Article. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Article 18
Union reporting
1.           Member States shall report to the
Commission and to the other Member States the information on listed diseases referred
to in in Article 8(1)(e) for which:
(a)     an immediate notification of outbreaks
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
accordance with the rules laid down in an implementing act adopted in
accordance with Article 35. 
2.           The reports provided for in
paragraph 1 shall include information on: 
(a)     the detection of the listed diseases
referred to in paragraph 1;
(b)     the results of surveillance when
required in accordance with rules adopted in accordance with Article 29(b)(ii);

(c)     the results of surveillance programmes
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
adopted in accordance with Article 35.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning amending and
supplementing the requirements of paragraph 2 of this Article and reporting on
other matters where necessary to ensure an efficient application of the disease
prevention and control rules of this Regulation. 
Article 19
Common rules for Union notification and Union reporting
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
management 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 reporting provided for in Articles 17(1) and 18(1).
Article 20
Computerised information system for Union notification and Union reporting of
diseases 
The Commission shall set up and manage a
computerised information system for the operation of the mechanisms and tools for
the Union notification and Union reporting requirements provided for in
Articles 17, 18 and 19. 
Article 21
Implementing powers concerning Union notification and Union reporting and the computerised
information system
The Commission shall by means of
implementing acts lay down rules for the Union notification and Union reporting
requirements and the computerised information system provided for in Articles 17
to 20 with respect to:
(a)          the information to be provided by the Member States in
the Union notification and Union reporting provided for in Articles 17(1) and 18(1);
(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).
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Chapter 2
Surveillance
Article 22
Operators' obligation for surveillance 
For the purpose of detecting the presence
of listed diseases and emerging diseases, operators shall: 
(a)          observe the health and behaviour
of animals under their responsibility;
(b)          observe any changes in the normal
production parameters in the establishments, animals or germinal products under
their responsibility, that may give rise to a suspicion of being caused by a listed
disease or emerging disease;
(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 responsibility receive animal health visits from a
veterinarian when appropriate due to the risks posed by the establishment,
taking into account:
(a)     the type of establishment;
(b)     the categories and species of kept
animals on the establishment;
(c)     any other relevant surveillance,
quality assurance schemes or official controls that the kept animals and type
of establishment are subject to.
Those animal health visits shall be at
frequencies that are proportionate to the risks posed by the establishment.
They may be combined with visits for other
purposes.
2.           The animal health visits provided
for in paragraph 1 shall be for the purposes of:
(a)     the detection of any signs indicative
of the occurrence of listed diseases or emerging diseases;
(b)     providing advice to the operator on
biosecurity and other animal health matters, as relevant for the type of
establishment and the categories and species of kept animals on the
establishment.
Article 24
Delegation of powers concerning animal health visits
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning:
(a)          supplementing: 
(i)      the criteria laid down in Article 23(1)
to be taken into account when determining: 
–              
which type of establishments must be subject to
animal health visits; 
–              
the frequency of such animal health visits;
(ii)     the requirements laid down in Article
23(2) as regards the content and frequency of animal health visits for the different
types of establishments, to ensure that the purposes of the animal health
visits are achieved;
(b)          determining the types of
establishments to be subject to animal health visits. 
Article 25
The competent authority's obligation for surveillance
1.           The competent authority shall
conduct surveillance for the presence of listed diseases referred to in Article
8(1)(e) and for emerging diseases. 
2.           The surveillance shall be
designed to ensure the timely detection of the presence of the listed diseases referred
to in Article 8(1)(e) and emerging diseases by collecting, collating and
analysing relevant information relating to the disease situation.
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,
frequency, intensity, targeted animal population, and sampling patterns of the
surveillance provided for in Article 25(1) shall be appropriate and
proportionate to the objectives of the surveillance, taking into account: 
(a)          the disease profile; 
(b)          the risk factors involved; 
(c)          the health status in: 
(i)      the Member State, zone or compartment
thereof subject to the surveillance;
(ii)     the Member States and third countries
or territories, which either border on, or from which animals and products
enter into that Member State, zone or compartment thereof;
(d)          surveillance conducted by
operators in accordance with Article 22, or by other public authorities. 
Article 27
Surveillance programmes
1.           The competent authority shall
undertake surveillance provided for in Article 25(1) in the framework of a
surveillance programme, when structured surveillance is necessary due to:
(a)     the disease profile; 
(b)     the risk factors involved.
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 programme in accordance with paragraph 1 shall submit regular
reports on the results of that surveillance programme to the Commission. 
Article 28
Delegation of powers
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning:
(a)          the design, means, diagnostic
methods, frequency, intensity, targeted animal population, and sampling
patterns of the surveillance as provided for in Article 26; 
(b)          the criteria for the official
confirmation and case definitions of listed diseases referred to in Article 8(1)(e)
and where relevant emerging diseases;
(c)          requirements for surveillance
programmes provided for in Article 27(1) regarding:
(i)      the contents of surveillance
programmes;
(ii)     the information to be included in the
submission of surveillance programmes in accordance with Article 27(2) and
regular reports in accordance with Article 27(3);
(iii)     the period of application of surveillance
programmes.
Article 29
Implementing powers
The Commission shall by means of
implementing acts, lay down requirements concerning surveillance and
surveillance programmes provided for in Articles 26 and 27 and rules adopted
pursuant to Article 28 on:
(a)          establishing which of the listed
diseases referred to in Article 8(1)(e) are to be subject to surveillance
programmes;
(b)          the format and procedure for:
(i)      the submission of surveillance
programmes for information to the Commission and other Member States; 
(ii)     the reporting to the Commission on
the results of the surveillance. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Chapter 3 
Eradication programmes
Article 30
Compulsory and voluntary eradication programmes
1.           Member States which are not free
or not known to be free from one or more of the listed diseases referred to in
Article 8(1)(b) in their whole territory or in zones or compartments thereof,
shall:
(a)     establish a programme for the
eradication of or demonstration of freedom from that listed disease, to be
carried out in the animal populations concerned by that disease and covering
the relevant parts of their territory or the relevant zones or compartments
thereof ("compulsory eradication programme");
(b)     submit the draft compulsory
eradication programme to the Commission, for approval. 
2.           Member States which are not free
or not known to be free from one or more of the listed diseases referred to in
Article 8(1)(c) and which decide to establish a programme for the eradication
of that listed disease to be carried out in the animal populations concerned by
it and covering the relevant parts of their territory or zones or compartments
thereof ("voluntary eradication programme") shall submit it to the Commission
for approval
3.           The Commission shall, by means of
implementing acts, approve:
(a)     draft compulsory eradication
programmes submitted to it for approval in accordance with paragraph 1;
(b)     draft voluntary eradication programmes
submitted to it for approval in accordance with paragraph 2.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
On duly justified imperative grounds of urgency
relating to a listed disease representing a risk of highly significant impact
the Commission shall adopt immediately applicable implementing acts provided
for in point (a) of this paragraph in accordance with the procedure provided
for in Article 255(3).
The Commission may, by means of implementing
acts, amend or terminate where necessary eradication programmes approved in
accordance with points (a) and (b). Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
4.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     the objectives, disease control
strategies and intermediate targets of compulsory and voluntary eradication
programmes;
(b)     derogations from the requirement for
the submission of compulsory eradication programmes and voluntary eradication
programmes for approval, as provided for in paragraph 1(b) and paragraph 2 of
this Article, where such approval is not necessary due to the adoption of rules
regarding those programmes in accordance with Articles 31(2) and 34(2) and
Article 35;
(c)     the information to be provided by
Member States to the Commission and to the other Member States concerning
derogations from the requirement for approval of compulsory eradication
programmes and voluntary eradication programmes provided for in (b).
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 amending or terminating rules
adopted pursuant to point (b) of this paragraph.
Article 31
Measures under the compulsory and voluntary eradication programmes
1.           Compulsory eradication programmes
and voluntary eradication programmes shall consist of at least the following
measures:
(a)     disease control measures for the
eradication of the disease agent from establishments, compartments and zones in
which the disease occurs and to prevent re-infection;
(b)     surveillance carried out in accordance
with the rules laid down in Article 26 to 29 to demonstrate:
(i)      the effectiveness of the disease
control measures provided for in point (a);
(ii)      freedom from the listed disease;
(c)     disease control measures to be taken
in the event of positive surveillance results.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     disease control measures as provided
for in paragraph 1(a); 
(b)     disease control measures to be taken
to avoid re-infection of the targeted animal population with the disease in
question in establishments, zones and compartments;
(c)     the surveillance design, means, diagnostic
methods, frequency, intensity, targeted animal population and sampling patterns
as provided for in Article 26;
(d)     disease control measures to be taken
in the event of the occurrence of positive results for the listed disease as
provided for in paragraph 1(c);
(e)     vaccination. 
Article 32
Content of the submission of compulsory and voluntary eradication programmes
Member States shall include the following
information in applications for compulsory and voluntary eradication programmes
submitted to the Commission for approval in accordance with Article 30(1) and (2):
(a)          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 geographical 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 compulsory
or voluntary eradication programme;
(e)          the intermediate targets and the
disease control strategies for undertaking the compulsory or voluntary
eradication programme;
(f)           an analysis of the estimated
costs and benefits of the compulsory or voluntary eradication programme.
Article 33
Reporting
The Member State undertaking the compulsory
or voluntary eradication programme shall submit to the Commission: 
(a)          regular intermediate reports to
monitor the intermediate targets referred to in Article 32(e) of the on-going
compulsory or voluntary programmes;
(b)          a final report after its
completion. 
Article 34
Period of application of eradication programmes
1.           Compulsory and voluntary eradication
programmes shall apply until:
(a)     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
withdrawn by the competent authority or by the Commission in accordance with
the procedure under which it was established.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning supplementing
and amending the requirements provided for in paragraph 1 of this Article as
regards the period of application of compulsory and voluntary eradication programmes.
Article 35
Implementing powers
The Commission shall by means of
implementing acts, lay down the information, format and procedural requirements
concerning the rules provided for in Articles 30 to 33 on:
(a)          the submission of draft
compulsory and draft voluntary eradication programmes for approval; 
(b)          performance indicators;
(c)          the reporting to the Commission
and other Member States on the results of the implementation of compulsory or
voluntary eradication programmes. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Chapter 4
Disease-free status
Article 36
Disease-free Member States and zones 
1.           A Member State may apply to the
Commission for approval of the disease-free status for one or more of the
listed diseases referred to in Article 8(1)(b) and (c) for its entire
territory, or for one or more zones thereof provided that one or more of the
following conditions are fulfilled:
(a)     none of the listed species for the
disease covered by the application for disease-free status is present in the
entire territory of the Member State or in the relevant zone or zones covered
by that application; 
(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 that 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 disease has
been demonstrated by:
(i)      an eradication programme complying
with the rules laid down in Article 31(1) and rules adopted pursuant to
paragraph 2 of that Article; or
(ii)      historical and surveillance data.
2.           Applications by Member States for
disease-free status shall include evidence to substantiate that the conditions
for disease-free status laid down in paragraph 1 are fulfilled.
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
Commission for the recognition of the disease-free status of compartments for
listed diseases referred to in Article 8(1)(a), and for the protection of such disease-free
status of that compartment in the event of outbreaks of one or more of those
listed diseases in its territory provided that: 
(a)     the introduction of the listed disease
or listed diseases covered by that application can be effectively prevented at
compartment level, taking into account the disease profile;
(b)     the compartment covered by the
application is subject to a single common biosecurity management system to
ensure the disease-free status of all establishments forming part of it;
(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
compartments keeping aquaculture animals and products thereof.
2.           A Member State may apply to the
Commission for the recognition of disease-free status of compartments for one
or more of the listed diseases referred to in Article 8(1)(b) and (c),
provided that:
(a)     the introduction of the listed disease
or listed diseases covered by that application can be effectively prevented at
compartment level, taking into account the disease profile;
(b)     one or more of the following
conditions are complied with: 
(i)      the conditions provided for in
Article 36(1)(a) to (d); 
(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
compartments keeping aquaculture animals and products thereof.
3.           Applications by Member States for
the recognition of disease-free status of compartments in accordance with
paragraphs 1 and 2 shall include evidence to substantiate that the conditions
laid down in those paragraphs are fulfilled. 
4.           The Commission shall, by means of
implementing acts recognise, subject to amendments where necessary, the disease-free
status of compartments, when the conditions provided for in paragraphs 1 or 2
and 3 are fulfilled. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
5.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning: 
(a)     the requirements for the recognition
of the disease free status of compartments as provided for in paragraphs 1 and
2 of this Article, taking into account the profile of the listed diseases referred
to in Article 8(1)(a), (b) and (c), concerning at least:
(i)      surveillance and other evidence
needed to substantiate disease-freedom;
(ii)      biosecurity measures;
(b)     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 the
territory of more than one Member State.
Article 38
Lists of disease-free zones or compartments
Each Member State shall establish and
maintain an updated list of:
(a)          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 concerning the disease-free status of Member States and
zones
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning:
(a)          detailed rules for the
disease-free status of Member States and zones thereof taking into account the
different disease profiles concerning:
(i)      the criteria to be used to substantiate
claims by Member States that no listed species are present or able to survive
and the evidence required to substantiate such claims, as provided for in
Article 36(1)(a);
(ii)     the criteria to be used to
substantiate that a disease agent or vector is not able to survive and the evidence
required to substantiate such claims as provided for in Article 36(1)(b) and
(c);
(iii)     the criteria to be used to determine
freedom from the disease, as referred to in Article 36(1)(d);
(iv)    surveillance and other evidence needed
to substantiate disease freedom;
(v)     biosecurity measures;
(vi)    restrictions and conditions for
vaccination in disease free Member States and zones thereof;
(vii)    establishment of the zones separating
the disease-free zones or zones under the eradication programme from the
restricted zones ("buffer zones");
(viii)   zones which extend over the territory
of more than one Member State;
(b)          derogations from the requirement for
the approval by the Commission of disease-free status for one or more listed
diseases referred to in Article 8(1)(b) and (c) as provided for in Article
36(1), where such approval is not necessary due to detailed rules for disease
freedom having been laid down in rules adopted pursuant to point (a) of this
Article;
(c)          the information to be provided by
Member States to the Commission and the other Member States to substantiate the
declarations of disease-free status, without the adoption of an implementing
act in accordance with Article 36(3), as provided for in point (b) of this
Article.
Article 40
Implementing powers
The Commission shall by means of implementing acts, lay down requirements
for the disease-free status of territories, zones and compartments concerning the
rules provided for in Articles 36, 37 and 38, and rules laid down in delegated
acts adopted pursuant to Article 39 concerning: 
(a)          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
status of the entire territory of the Member State, or zones and compartments
thereof;
(ii)     the information exchange between the Member
States and the Commission on disease-free Member States, or zones and
compartments thereof.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Article 41
Maintenance of disease-free status
1.           Member States shall only maintain
disease-free status for their territories, or zones or compartments thereof as
long as:
(a)     the conditions for disease-free status
laid down in Article 36(1) and 37(1) and (2), and rules laid down pursuant to
paragraph 3 of this Article and Article 39 remain fulfilled;
(b)     surveillance, taking into account the
requirements provided for in Article 26, is undertaken to verify that the
territory, zone or compartment remains free of the listed disease for which it
was approved or recognised for disease-free status;
(c)     restrictions are applied on movements
of animals, and where relevant their products, of listed species for the listed
disease for which the disease-free status was approved or recognised, into the
territory, zone or compartment, in accordance with the rules laid down in Parts
IV and V; 
(d)     other biosecurity measures are applied
to prevent the introduction of the listed disease for which it was approved or
recognised for disease-free status.
2.           A Member State shall immediately
inform the Commission if the conditions referred to in paragraph 1 for
maintaining disease-free status no longer apply. 
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the following
conditions for maintaining disease-free status:
(a)     surveillance as provided for in
paragraph 1(b);
(b)     biosecurity measures as provided for
in paragraph 1(c).
Article 42
Suspension, withdrawal and restoration of disease-free status
1.           Where a Member State has reason
to suspect that any of the conditions for maintaining its status as a
disease-free Member State, or zone or compartment thereof have been breached, it
shall immediately:
(a)     suspend movements of the listed
species, for the listed disease for which it was approved or recognised for
disease-free status, to other Member States, zones or compartments with a
higher health status for that listed disease 
(b)     where relevant for the prevention of
the spread of a listed diseas for which disease-free status was approved or
recognised, apply the disease control measures provided for in Title II of Part
III.
2.           The measures provided for in
paragraph 1 shall be lifted where further investigation confirms that:
(a)     the suspected breach has not taken
place; or 
(b)     the suspected breach did not have significant
impact and the Member State can provide assurances that the conditions for
maintaining its disease-free status are again fulfilled.
3.           Where further investigation by
the Member State confirms a significant likelihood that the listed disease for
which it obtained the disease-free status or other significant breaches of the
conditions for maintaining disease-free status have occurred, the Member State shall
immediately inform the Commission.
4.           The Commission shall, by means of
implementing acts, withdraw the approval of the disease-free status of a Member
State or zone granted in accordance with Article 36(3) or the recognition
of the disease-free status of a compartment granted in accordance with Article 37(4)
after obtaining the information from the Member State referred to in paragraph
3 of this Article that the conditions for maintaining the disease-free status
are no longer met . 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
On duly justified imperative grounds of extreme
urgency, where the listed disease referred to in paragraph 3 of this Article spreads
in a rapid manner with risk of highly significant impact on animal or public health,
the economy or society, the Commission shall adopt immediately applicable
implementing acts in accordance with the procedure provided for in Article 255(3).
5.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the rules for
the suspension, withdrawal and restoration of disease-free status provided for
in paragraphs 1 and 2 of this Article.
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 keep up-to-date-contingency plans and where necessary detailed instruction
manuals laying down the measures to be taken in the Member State in the event
of the occurrence of a case or an outbreak of a listed disease referred to in
Article 8(1)(a) or an emerging diseases in order to ensure a high level of
disease awareness, preparedness and rapid response.
2.           The contingency plans and where applicable
detailed instruction manuals shall cover at least the following matters: 
(a)         
the establishment of a chain of command within
the competent authority and with other public authorities to ensure a rapid and
effective decision-making process at Member State, regional and local level;
(b)         
the framework for cooperation between the
competent authority and the other public authorities involved to ensure that
actions are taken in a coherent and coordinated manner;
(c)         
access to: 
(i)      facilities; 
(ii)      laboratories; 
(iii)     equipment; 
(iv)     personnel;
(v)     emergency funds; 
(vi)     all other appropriate materials and
resources necessary for the rapid and efficient eradication of the listed
diseases referred to in Article 8(1)(a) or the emerging diseases; 
(d)         
the availability of the following centres and
groups with the necessary expertise to assist the competent authority:
(i)      a functional central disease control
centre; 
(ii)      regional and local disease control
centres, as appropriate for the administrative and geographical situation of
the Member States;
(iii)     operational expert groups;
(e)         
the implementation of the disease control
measures provided for in Chapter 1 of Title II for the listed diseases referred
to in Article 8(1)(a) and for emerging diseases; 
(f)           
provisions on emergency vaccination where appropriate;

(g)         
principles for the geographical demarcation of
the restricted zones established by the competent authority in accordance with
Article 64(1);
(h)         
coordination with neighbouring Member States and
neighbouring third countries and territories, where appropriate. 
Article 44
Delegation of powers and implementing powers for contingency plans
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed
requirements and conditions for the contingency plans provided for in Article 43(1)
and to supplement the requirements laid down in Article 43(2), taking into
account:
(a)     the objectives of the contingency
plans to ensure a high level of disease awareness, preparedness and rapid
response;
(b)     the disease profile of the listed
diseases referred to in Article 8(1)(a);
(c)     new knowledge of and developments in
disease control tools.
2.           The Commission shall, by means of
implementing acts, lay down requirements concerning the practical
implementation in the Member States of the contingency plans provided for in Article
43(1) with regard to: 
(a)     the matters provided for in Article 43(2)(a)
and (c) to (h); 
(b)     other operational aspects of the contingency
plans in the Member States;
(c)     detailed requirements and conditions
for the practical implementation of the delegated acts adopted pursuant to
paragraph 1 of this Article.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Article 45
Simulation exercises 
1.           The competent authority shall
ensure that simulation exercises concerning the contingency plans provided for
in Article 43(1) are carried out regularly:
(a)     to ensure a high level of disease
awareness, preparedness and rapid response in the Member State;
(b)     to verify the functionality of those
contingency plans. 
2.           Where feasible and appropriate,
simulation exercises shall be carried out in close collaboration with the
competent authorities of neighbouring Member States and neighbouring third
countries and territories. 
3.           Member States shall make
available on request a report on the main results of the simulation exercises
to the Commission and to the other Member States.
4.           When appropriate and necessary
the Commission shall, by means of implementing acts, lay down rules concerning
the practical implementation of simulation exercises in the Member States on:
(a)     the frequencies, contents and format
of simulation exercises;
(b)     simulation exercises covering more
than one listed disease referred to in Article 8(1)(a);
(c)     collaboration between neighbouring Member
States and with neighbouring third countries and territories.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Chapter 2
The use of veterinary medicinal products for disease prevention and control 
Article 46
The use of veterinary medicinal products for disease prevention and control
1.           The Member States may take
measures concerning the use of veterinary medicinal products for listed
diseases, to ensure the most efficient disease prevention or control for those
diseases, provided that such measures comply with the rules on the use of
veterinary medicinal products laid down in delegated acts adopted pursuant to
Article 47. 
Those measures may cover the following: 
(a)     prohibitions and restrictions on the
use of veterinary medicinal products;
(b)     the compulsory use of veterinary
medicinal products.
2.           Member States shall take the
following criteria into consideration when determining whether or not to use
and how to use veterinary medicinal products as disease prevention and control
measures for a specific listed disease:
(a)     the disease profile;
(b)     the distribution of the listed disease
in:
(i)      the Member State; 
(ii)      the Union;
(iii)     where relevant, in neighbouring
third countries and territories; 
(iv)     third countries and territories from
which animals and products are brought into the Union;
(c)     the availability, effectiveness and
risks of the veterinary medicinal products;
(d)     the availability of diagnostic tests
for 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
compared to other available disease prevention and control strategies.
3.           Member States shall take
appropriate preventive measures concerning the use of veterinary medicinal
products for scientific studies or for the purposes of developing and testing them
under controlled conditions to protect animal and public health.
Article 47 
Delegation of powers for the use of veterinary medicinal products
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     prohibitions and restrictions on the
use of veterinary medicinal products;
(b)     specific conditions for the use
veterinary medicinal products for a specific listed disease;
(c)     the compulsory use of veterinary
medicinal products;
(d)     risk mitigating measures to prevent
the spread of listed diseases through animals treated with the veterinary
medicinal products or products from such animals;
(e)     surveillance following the use of
vaccines and other veterinary medicinal products for specific listed diseases.
2.           The Commission shall take into
account the criteria provided for in Article 46(2) when laying down the rules
provided for in paragraph 1 of this Article.
3.           Where in the case of emerging
risks, imperative grounds of urgency so require, the procedure provided for in
Article 254 shall apply to rules adopted pursuant to paragraph 1 of this
Article.
Chapter 3
Antigen, vaccine and diagnostic reagent banks
Article 48
The establishment of Union antigen, vaccine and diagnostic reagent banks 
1.           For listed diseases referred to in
Article 8(1)(a) for which vaccination is not prohibited by a delegated act
adopted pursuant to Article 47(1), the Commission may establish and be responsible
for managing Union antigen, vaccine and diagnostic reagent banks for the
storage and replacement of stocks of one or more of the following biological
products:
(a)     antigens; 
(b)     vaccines; 
(c)     vaccine master seed-stocks;
(d)     diagnostic reagents.
2.           The Commission shall ensure that the
Union antigen, vaccine and diagnostic reagent banks provided for in paragraph
1:
(a)     store sufficient stocks of the appropriate
type of antigens, vaccines, vaccine master seed-stocks and diagnostic reagents for
the specific listed disease, taking into account the needs of Member States
estimated in the context of the contingency plans provided for in Article 43(1);
(b)     receive regular supplies and timely replacements
of antigens, vaccines, vaccine master seed-stocks and diagnostic reagents; 
(c)     are maintained and moved under the appropriate
biosecurity, biosafety and bio-containment standards as provided for in Article
15(1) and delegated acts adopted pursuant to Article 15(2);
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     the management, storage and
replacement of stocks of the Union antigen, vaccine and diagnostic reagent
banks as provided for in paragraphs 1 and 2;
(b)     the biosecurity, biosafety and bio-containment
requirements for their operation taking into account the requirements provided
for in Article 15(1) and delegated acts adopted pursuant to Article 15(2).
Article 49
Access to the Union antigen, vaccine and diagnostic reagent banks
1.           The Commission shall provide for
the delivery of the biological products referred to in Article 48(1) from the
Union antigen, vaccine and diagnostic reagent banks upon request, provided that
stocks are available, to: 
(a)     Member States;
(b)     third countries or territories,
provided that it is primarily intended to prevent the spread of a disease into
the Union.
2.           The Commission shall prioritise
the access provided for in paragraph 1 in the event of the limited availability
of stocks taking into account:
(a)     the disease circumstances under which
the request is made;
(b)     the existence of a national antigen,
vaccine and diagnostic reagent bank in the requesting Member State or third
country or territory;
(c)     the existence of Union measures for
compulsory vaccination laid down in delegated acts adopted pursuant to Article
47(1).
Article 50
Implementing powers concerning the Union antigen, vaccine and diagnostic
reagent banks
The Commission shall, by means of implementing
acts, lay down rules for Union antigen, vaccine and diagnostic reagent banks
specifying for the biological products referred to in Article 48(1):
(a)          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 that are to be
included in the Union antigen, vaccine and diagnostic reagent bank and in what
quantities for each specific listed disease referred to in Article 8(1)(a), for
which the bank exists;
(c)          the requirements concerning the supply, storage 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 States and to
third countries and territories;
(e)          procedural and technical requirements for the inclusion
of those biological products in the Union antigen, vaccine and diagnostic
reagent banks and for requesting access to them.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
On duly justified imperative grounds of
urgency relating to a listed disease referred to in Article 8(1)(a)
representing a risk of highly significant impact the Commission shall adopt
immediately applicable implementing acts in accordance with the procedure
provided for in Article 255(3).
Article 51
Confidentiality of information concerning the Union antigen, vaccine and
diagnostic reagent banks
Information on the quantities and subtypes
of the biological products referred to in Article 48(1) stored in the Union
antigen, vaccine and diagnostic reagent banks shall be treated as classified
information and shall not be published.
Article 52
National antigen, vaccine and diagnostic reagent banks
1.           Member States that have
established national antigen, vaccine and diagnostic reagent banks for listed
diseases referred to in Article 8(1)(a) for which Union antigen, vaccine and
diagnostic reagent banks exist, shall ensure that their national antigen, vaccine
and diagnostic reagent banks comply with the biosecurity, biosafety and bio-containment
requirements provided for in Article 15(1)(a) and delegated acts adopted in
accordance with Article 15(2) and Article 48(3)(b). 
2.           Member States shall provide the Commission
and the other Members States with up-to-date information on: 
(a)     the existence or the establishment of
national antigen, vaccine and diagnostic reagent banks referred to paragraph 1;
(b)     the types of antigens, vaccines,
vaccine master seed stocks and diagnostic reagents and their quantities in such
banks;
(c)     any changes in their operation. 
3.           The Commission may, by means of
implementing acts, lay down rules specifying the content, frequency, and format
of the submission of the information provided for in paragraph 2 of this
Article.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
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 shall, in addition to notifying the signs or suspicion to the
competent authority and veterinarians in accordance with Article 16(1) and
pending any disease control measures being taken by the competent authority in
accordance with Articles 54(1) and 55(1), take the appropriate disease control
measures provided for in Article 55(1)(c), (d) and (e) to prevent the spread of that listed disease from the affected animals, establishments and locations under their
responsibility to other animals or to humans.
2.           The Commission shall be empowered to adopt delegated acts in
accordance with Article 253 concerning detailed rules for supplementing the
disease control measures to be taken by the operators, animal professionals and
pet keepers as provided for in paragraph 1 of this Article.
Article 54
Investigation by the competent authority in the event of suspicion of a listed disease
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 presence of that listed disease.
2.           For the purpose of the
investigation provided for in paragraph 1, the competent authority shall, when
appropriate, ensure that official veterinarians:
(a)     carry out a clinical examination of a
representative sample of the kept animals of listed species for that particular
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
confirm or rule out the presence of the particular listed disease.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed
rules supplementing the rules for the investigation by the competent authority provided
for in paragraph 1 of this Article.
Article 55
Preliminary disease control measures by the competent authority 
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 control measures in accordance with Article 61(1):
(a)     place the establishment, household,
food and feed business or animal by-products establishment, or any other
location where the disease suspicion occurs under official surveillance;
(b)     compile an inventory of: 
(i)      the kept animals in the establishment,
household, food and feed business or animal by-products establishment, or any
other location; 
(ii)      the products in the establishment,
household, food and feed business or animal by-products establishment, or any
other location, where relevant for the spread of that listed disease;
(c)     apply appropriate biosecurity measures
to prevent the spreading of that listed disease agent to other animals or to humans;
(d)     when appropriate to prevent the
further spread of the disease agent, keep the kept animals of listed species
for that listed disease isolated, and prevent contact with wildlife; 
(e)     restrict the movements of kept animals,
products and, if appropriate, people, vehicles and any material or other means
by which the disease agent could have spread to or from the establishment,
households, food and feed business establishments, animal by-products establishments
or any other location where that listed disease is suspected, as far as
necessary to prevent its spread of the listed disease;
(f)      take any other necessary disease
control measures, taking into account the disease control measures provided for
in Section 4, concerning: 
(i)      the application of the investigation
by the competent authority provided for in Article 54(1) and disease control
measures provided for in points (a) to (d) of this paragraph to other
establishments, epidemiological units therein, households, food and feed
businesses or animal by-products establishments; 
(ii)      the establishment of temporary
restricted zones, which are appropriate taking into account the disease
profile;
(g)     initiate the epidemiological enquiry
provided for in Article 57(1);
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed
rules supplementing those laid down in paragraph 1 of this Article as regards
the specific and detailed disease control measures to be taken depending on the
listed disease referred to in Article 8(1)(a), taking into account the risks
involved for: 
(a)     the species or category of animals; 
(b)     the type of production.
Article 56
Review and extension of the preliminary disease control measures
The disease control measures provided for
in Article 55(1) shall be:
(a)          reviewed by the competent
authority, as appropriate, following the findings of: 
(i)      the investigation provided for in
Article 54(1); 
(ii)     the epidemiological enquiry provided
for in Article 57(1);
(b)          further extended to other
locations as referred to in Article 55(1)(e), where necessary.
Section 2
Epidemiological Enquiry
Article 57
Epidemiological enquiry 
1.           The competent authority shall
carry out an epidemiological enquiry in event of the suspicion or confirmation
of a listed disease referred to in Article 8(1)(a) in animals.
2.           The epidemiological enquiry
provided for in paragraph 1 shall aim at:
(a)     identifying the likely origin of the listed
disease and the means of its spread;
(b)     calculating the likely length of time
that the listed disease has been present;
(c)     identifying contact establishments and
epidemiological units therein, households, food and feed business or animal
by-products establishment or any other locations where animals of listed
species for the suspected listed disease may have become infected, infested or
contaminated;
(d)     obtaining information on the movements
of kept animals, persons, products, vehicles, any material or other means by
which the disease agent could have been spread during the relevant period
preceding the notification of the suspicion or confirmation of the listed disease;
(e)     obtaining information on the likely
spread of the listed disease in the surrounding environment, including the
presence and distribution of disease vectors. 
Section 3
Disease confirmation in kept animals
Article 58
Official confirmation by the competent authority of a listed disease referred
to in Article 8(1)(a) 
1.           The competent authority shall
base an official confirmation of a listed disease referred to in Article 8(1)(a)
on the following information:
(a)     the results of the clinical and
laboratory examinations provided for in Article 54(2);
(b)     the epidemiological enquiry provided
for in Article 57(1);
(c)     other available epidemiological data. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the requirements
to be fulfilled for the official confirmation referred to in paragraph 1of this
Article.
Article 59
Lifting of preliminary disease control measures where the presence of the
listed disease has been ruled out
The competent authority shall continue to
apply the preliminary disease control measures provided for in Article 55(1)
and Article 56, until the presence of the listed diseases referred to in
Article 8(1)(a) has been ruled out based on the information referred to in
Article 58(1) or rules adopted pursuant to Article 58(2).
Section 4
Disease control measures in the event of disease confirmation in
kept animals 
Article 60
Immediate disease control measures to be taken by the competent authority 
In the event of official confirmation in
accordance with Article 58(1) of an outbreak of a listed disease referred to in
Article 8(1)(a) in kept animals, the competent authority shall immediately:
(a)          declare the affected
establishment, household, food or feed business, animal by-products
establishment or other location as officially infected with that listed disease;
(b)          establish a restricted zone, as appropriate
for that listed disease;
(c)          implement the contingency plan
provided for in Article 43(1) to ensure full coordination of the disease
control measures.
Article 61
Affected establishments and other locations
1.           In the event of an outbreak of a listed
disease referred to in Article 8(1)(a) in kept animals in an establishment,
household, food or feed business, animal by-products establishment or any other
location, the competent authority shall immediately take one or more of the
following disease control measures in order to prevent the further spread of
that listed disease:
(a)     movement restrictions for persons,
animals, products, vehicles or any other material or substance that may be
contaminated and contribute to the spread of the listed disease;
(b)     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,
transformation or treatment of products, feed, or any other substances, or the
treatment of equipment, means of transport, plants or plant products, or water
which may be contaminated, as appropriate to ensure that any disease agent or
vector of the disease agent is destroyed; 
(d)     the vaccination or treatment with
other veterinary medicinal products of kept animals in accordance with Article 46(1)
and any delegated acts adopted pursuant to Article 47(1);
(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, disinfestation
or other necessary biosecurity measures to be applied to the affected
establishment, household, food or feed business, animal by-products
establishment or other locations to minimise the risk of spread of the listed disease;
(g)     the taking of a sufficient number of
appropriate samples needed to complete the epidemiological enquiry provided for
in Article 57(1);
(h)     the laboratory examination of samples.
2.           When determining which of the
disease control measures provided for in paragraph 1 are appropriate to take,
the competent authority shall take the following into account: 
(a)     the disease profile;
(b)     the type of production, and
epidemiological units within the affected establishment, household, food or
feed business, animal by-products establishment or other location.
3.           The competent authority shall
only authorise the repopulation of the establishment, household or any other
location when: 
(a)     all appropriate disease control
measures and laboratory examinations provided for in paragraph 1 have been
successfully completed;
(b)     a sufficient period of time has
elapsed to prevent re-contamination of the affected establishment, household,
food or feed business, animal by-products establishment and other location with
the listed disease that caused the outbreak referred to in paragraph 1. 
Article 62
Epidemiologically linked establishments and locations 
1.           The competent authority shall
extend the disease control measures provided for in Article 61(1) to other
establishments, epidemiological units therein, households, food or feed
businesses or animal by-products establishments, or any other location, or means
of transport where the epidemiological enquiry provided for in Article 57(1), or
the results of clinical or laboratory investigations or other epidemiological
data give reason to suspect the spread to, from or through them of the listed
disease referred to in Article 8(1)(a) for which such measures were taken.
2.           If the epidemiological enquiry
provided for in Article 57(1) shows that the likely origin of the listed
disease referred to in Article 8(1)(a) is another Member State or it is likely
that that listed disease has spread to another Member State, the competent
authority shall inform that Member State.
3.           In the events referred to in
paragraph 2, the competent authorities of the different Member States shall cooperate
in a further epidemiological enquiry and in the application of disease control
measures.
Article 63
Delegating power for the disease control measures in affected and epidemiologically
linked establishments and locations
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning detailed rules on the
disease control measures to be taken by the competent authority in accordance
with Articles 61 and 62 in affected and epidemiologically linked establishments,
food or feed businesses or animal by-products establishments and locations for
any listed disease referred to in Article 8(1)(a).
Those detailed rules shall cover the
following matters:
(a)          the conditions and requirements
for the disease control measures, provided for in Article 61(1)(a) to (e);
(b)          the procedures for cleaning, disinfection
and disinfestation provided for in of Article 61(1)(f), specifying, where
appropriate the use of biocidal products for those purposes; 
(c)          the conditions and requirements
for sampling and laboratory examination provided for in Article 61(1)(g) to (h);
(d)          the detailed conditions and
requirements of repopulation provided for in Article 61(3);
(e)          the necessary disease control measures
provided for in Article 62 to be carried out in epidemiologically linked
establishments, locations and means of transport.
Article 64
Establishment of restricted zones by the competent authority
1.           The competent authority shall
establish a restricted zone around the affected establishment, household, food
or feed business, animal by-products establishment or other location where the
outbreak of a listed disease referred to in Article 8(1)(a) in kept animals has
occurred, where appropriate, taking into account: 
(a)     the disease profile;
(b)     the geographical situation of the
restricted zones;
(c)     the ecological and hydrological
factors of the restricted zones; 
(d)     the meteorological conditions;
(e)     the presence, distribution and type of
vectors in the restricted zones;
(f)      the results of the epidemiological
enquiry provided for in Article 57(1) and other studies carried out and
epidemiological data;
(g)     the results of laboratory tests;
(h)     the disease control measures applied. 
The restricted zone shall include, when
appropriate, a protection and surveillance zone of a defined size and
configuration. 
2.           The competent authority shall
continuously assess and review the situation and, when appropriate in order to
prevent the spread of the listed disease referred to in Article 8(1)(a):
(a)     adapt the boundaries of the restricted
zone;
(b)     establish additional restricted zones.
3.           Where the restricted zones are
situated in the territory of more than one Member State, the competent authorities
of those Member States shall cooperate in establishing the restricted zones
provided for in paragraph 1. 
4.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed
rules for the establishment and amendment of restricted zones, including
protection or surveillance zones. 
Article 65
Disease control measures in a restricted zone
1.           The competent authority shall
take one or more of the following disease control measures in the restricted
zone in order to prevent the further spread of the listed disease referred to in
Article 8(1)(a): 
(a)     the identification of establishments,
households, food or feed businesses, animal by-products establishments or other
locations with kept animals of listed species for that listed disease;
(b)     visits to establishments, households,
food or feed businesses, animal by-products establishments or other locations with
kept animals of listed species for that listed disease, and where necessary
examinations, sampling and laboratory examination of the samples; 
(c)     movement conditions for the movement
of persons, animals, products, feed, vehicles and any other material or
substance that may be contaminated or contribute to the spread of that listed
disease within and from the restricted zones and transport through the
restricted zones;
(d)     biosecurity requirements for: 
(i)      the production, processing and
distribution of products of animal origin; 
(ii)      the collection and disposal of
animal by-products; 
(iii)     artificial insemination.
(e)     the vaccination and treatment with
other veterinary medicinal products of kept animals in accordance with Article
46(1) and any delegated acts adopted pursuant to Article 47(1); 
(f)      cleaning, disinfection and
disinfestation; 
(g)     the designation or where relevant,
approval of a food business establishment for the purposes of the slaughtering
of animals or the treatment of products of animal origin originating from the
restricted zones;
(h)     the identification and traceability
requirements for the movement of animals, germinal products or products of
animal origin;
(i)      other necessary biosecurity and risk
mitigating measures to minimise the risks of the spread of that listed disease.
2.           The competent authority shall
take all necessary measures to fully inform the persons in the restriction
zones of the restrictions in force and the nature of the disease control measures.

3.           When determining which of the disease
control measures provided for in paragraph 1 are to be taken, the competent
authority shall take the following into account: 
(a)     the disease profile;
(b)     the types of production;
(c)     the feasibility, availability and
effectiveness of those disease control measures. 
Article 66
Operators obligations in restricted zones
1.           Operators keeping animals and
products in the restricted zone provided for in Article 64(1) shall notify any
intended movement of kept animals and products, within or out of the restricted
zone, to the competent authority.
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 disease 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, disinfection and
disinfestation provided for in Article 65(1)(f), specifying, where
appropriate the use of biocidal products for those purposes;
(c)          the necessary surveillance which is to be conducted
following the application of the disease control measures and laboratory
examinations provided for in Article 65(1)(b);
(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
disinfestation has been carried out as appropriate for:
(i)      the listed disease referred to in
Article 8(1)(a) for which the disease control measures have been applied; 
(ii)      the affected species of kept
animals; 
(iii)     the type of production; 
(c)     adequate surveillance, as appropriate
for the listed disease referred to in Article 8(1)(a) for which the disease
control measures have been applied, and the type of establishment or location
has been carried out in the restricted zone substantiating the eradication of
that listed disease. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed
rules for the disease control measures to be taken by the competent authority
as provided for in paragraph 1 of this Article in relation to: 
(a)     the final cleaning, disinfection or
disinfestation procedures, and where appropriate the use of biocidal products
for those purposes;
(b)     the design, means, methods, frequency,
intensity, targeted animal population and sampling patterns of surveillance to
regain disease-free status after the outbreak;
(c)     the repopulation of the restricted
zones after the completion of the disease control measures provided for in
paragraph 1 of this Article, taking into account the conditions for
repopulation provided for in Article 61(3); 
(d)     other disease control measures
necessary in order to regain the disease-free status.
Article 69
Emergency vaccination
1.           Where relevant for the effective
control of the listed disease referred to in Article 8(1)(a) for which the
disease control measures due to the outbreak apply, the competent authority may:

(a)     develop a vaccination plan;
(b)     establish vaccination zones. 
2.           The competent authority shall, when
deciding on the vaccination plan and the establishment of vaccination zones
provided for in paragraph 1 of this Article, take the following into account:
(a)     the requirements for emergency
vaccination provided for in the contingency plans provided for in Article 43(1);
(b)     the requirements for the use of
vaccines provided for in Article 46(1) and any delegated acts adopted pursuant
to Article 47(1).
3.           Vaccination zones provided for in
paragraph 1(b) of this Article shall comply with the requirements on risk
mitigating measures to prevent the spread of listed diseases and surveillance
as laid down in any delegated acts adopted in accordance with Article 47(1)(d)
and (e).
Section 5
Wild animals
Article 70
Wild animals
1.           In the event of the suspicion or official
confirmation of a listed disease referred to in Article 8(1)(a) in wild
animals, the affected Member State shall:
(a)     conduct, where relevant for that
particular listed disease, surveillance in the wild animal population; 
(b)     take the necessary disease prevention
and control measures to avoid the further spread of that listed disease. 
2.           The disease prevention and control
measures provided for in paragraph 1(b) shall take the following matters into
account:
(a)     the disease profile; 
(b)     the affected wild animals; 
(c)     the disease control measures to be
taken in the event of suspicion or official confirmation of a listed disease referred
to in Article 8(1)(a) in restricted zones in kept animals pursuant to rules
laid down in Sections 1 to 4. 
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning: 
(a)     surveillance pursuant to paragraph
1(a); 
(b)     disease prevention and control
measures pursuant to paragraph 1(b).
When adopting those delegated acts, the
Commission shall take into consideration the disease profile and the listed species
for the listed disease referred to paragraph 1.
Section 6
Additional disease control measures by the Member States, Coordination by the
Commission and temporary special disease control rules
Article 71
Additional disease control measures by the Member States, coordination of
measures by the Commission and temporary special disease control rules
concerning Sections 1 to 5
1.           Member States may take additional
disease control measures to those provided for in Article 61(1), Article 62,
Article 65(1) and (2) and Article 68(1) and in delegated acts adopted pursuant
to Article 67 and Article 68(2), provided that such measures are in line with
the rules laid down in this Regulation and they are necessary and proportionate
to control the spread of the listed disease referred to in Article 8(1)(a),
taking into account: 
(a)     the particular epidemiological
circumstances; 
(b)     the type of establishments, other
locations and production; 
(c)     the categories and species of animals
involved; 
(d)     economic or social conditions.
2.           Member States shall inform the
Commission without delay of: 
(a)     the disease control measures taken by
the competent authority as provided for in Articles 58, 59, 61, 62, 64 and 65, Article
68(1), Article 69 and Article 70(1) and (2) and delegated acts adopted pursuant
to Articles 63 and 67 and Articles 68(2) and 70(3); 
(b)     any additional disease control
measures taken by it as provided for in paragraph 1.
3.           The Commission shall review the
disease situation and the disease control measures taken by the competent
authority and any additional disease control measures taken by the Member
State, in accordance with this Chapter and may, by means of implementing acts,
lay down special disease control measures for a limited period of time, under
conditions appropriate to the epidemiological situation, where:
(a)     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).
4.           On duly justified imperative
grounds of urgency relating to a disease representing an emerging risk of
highly significant impact the Commission shall adopt immediately applicable
implementing acts in accordance with the procedure referred to in Article 255(3).
Chapter 2
Listed diseases referred to in Article 8(1)(b) and (c)
Section 1
Disease control measures in the event of suspicion of disease in kept animals
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 professionals and pet keepers shall, in addition to notifying the signs
and suspicion to the competent authority and veterinarians in accordance with
Article 16(1) and pending any disease control measures being taken by the
competent authority in accordance with Article 74(1), take appropriate
disease control measures referred to in Article 74(1)(a) and any delegated acts
adopted pursuant to Article 74(3) to prevent the spread of that listed disease
from the affected animals, establishments and
locations under their responsibility to other animals or to humans.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed
rules for supplementing the disease control measures to be taken by the operators,
animal professionals and pet keepers as provided for in paragraph 1 of this
Article.
Article 73 
Investigation by the competent authority in the event of suspicion of a listed disease
1.           The competent authority shall, in
the event of the suspicion of a listed disease referred to in Article 8(1)(b)
and (c) in kept animals, conduct without delay an investigation to confirm or
rule out the presence of that listed disease.
2.           For the purpose of the
investigation provided for in paragraph 1, the competent authority shall, when
appropriate, ensure that official veterinarians:
(a)     carry out a clinical examination of a
representative sample of the kept animals of listed species for that particular
listed disease; 
(b)     take appropriate samples from the kept
animals of listed species and other samples for laboratory examination in
laboratories designated for that purpose by the competent authority;
(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 adopt delegated acts in accordance with Article 253 concerning detailed
rules supplementing rules for the investigation provided for in paragraph 1
of this Article.
Article 74
Preliminary disease control measures by the competent authority 
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 animals carry out the following preliminary disease control
measures, pending the results of the investigation provided for in Article 73(1)
and the carrying out of disease control measures in accordance with Article 78(1)
and (2):
(a)     apply disease control measures to
limit the spread of that listed disease from the affected territory,
establishment, household, food or feed business, animal by-products establishment
or other location;
(b)     initiate where necessary, an
epidemiological enquiry, taking into account the rules for such investigation
provided for in Article 57(1) and any rules adopted pursuant to Article 57(2).
2.           The preliminary disease control
measures provided for in paragraph 1 shall be appropriate and proportionate to
the risk posed by the listed disease referred to in Article 8(1)(b) or (c) taking
into account the following:
(a)     the disease profile;
(b)     the kept animals affected;
(c)     the health status of the Member State,
zone, compartment or establishment in which that listed disease is suspected;
(d)     the preliminary disease control
measures provided for in Article 55(1) and Article 56 and any delegated
act adopted pursuant to Article 55(2).
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning rules
supplementing those laid down in paragraph 1 of this Article, while taking into
account the matters referred to in paragraph 2 of this Article, as regards:
(a)     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 disease
control measures provided for in paragraph 1(a) to other establishments,
epidemiological units therein, households, food or feed businesses and animal
by-products establishments or other locations;
(c)     the establishment of temporary
restricted zones, which are appropriate due to the disease profile.
Article 75
Review and extension of the preliminary disease control measures
The disease control measures provided for
in Article 74(1) shall be:
(a)          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 other
locations, as referred to in Article 74(3)(b) where necessary.
Section 2
Disease confirmation in kept animals
Article 76 
Official confirmation of disease by the competent authority
1.           The competent authority shall
base an official confirmation of a listed disease referred to in Article 8(1)(b)
or (c) on the following information:
(a)     the results of the clinical and
laboratory examinations provided for in Article 73(2);
(b)     the epidemiological enquiry provided
for in Article 74(1)(b), where relevant;
(c)     other available epidemiological data. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the requirements
to be fulfilled for the official confirmation referred to in paragraph 1of this
Article. 
Article 77
Lifting preliminary disease control measures when disease occurrence is ruled
out
The competent authority shall continue to
apply the preliminary disease control measures provided for in Article 74(1)
and Article 75 until the presence of the listed diseases referred to in Article
8(1)(b) or (c) has been ruled out in accordance with Article 76(1) or
rules adopted pursuant to Article 76(2).
Section 3
Disease Control measures in the event of disease confirmation in
kept animals 
Article 78
Disease control measures by the competent authority 
1.           In the event of an official
confirmation in accordance with Article 76(1) of an outbreak of a listed
disease referred to in Article 8(1)(b) in kept animals the competent authority
shall:
(a)     in a Member State, zone or compartment
subject to a compulsory eradication programme provided for in Article 30(1) for
that listed disease, apply the disease control measures laid down in that compulsory
eradication programme;
(b)     in a Member State, area, zone or
compartment that is not yet subject to a compulsory eradication programme provided
for in Article 30(1) for that listed disease, initiate that compulsory
eradication programme and apply the disease control measures laid down therein.
2.           In the event of an official
confirmation in accordance with Article 76(1) of an outbreak of a listed
disease referred to in Article 8(1)(c) in kept animals the competent authority
shall:
(a)     in a Member State, zone or compartment
subject to a voluntary eradication programme provided for in Article 30(2) for
that listed disease, apply the disease control measures laid down in that voluntary
eradication programme;
(b)     in a Member State, area, zone or
compartment that is not subject to a voluntary eradication programme provided
for in Article 30(2) for that listed disease, apply, when appropriate, measures
to control and prevent its spread.
3.           The measures provided for in
paragraph 2(b) of this Article shall be proportionate to the risk posed by the listed
disease referred to in Article 8(1)(c) in question taking into account:
(a)     the disease profile;
(b)     the kept animals affected;
(c)     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 Section 4 of Chapter 1 of this Title. 
Article 79
Delegation of powers for the disease control measures to be taken by the
competent authority
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 laying down detailed rules
concerning the disease control measures to be taken in the event of outbreaks
of a listed disease referred to in Article 8(1)(b) or (c) in kept animals
as provided for in Article 78(2)(b) taking into account the criteria provided
for in Article 78(3).
Section 4
Wild animals 
Article 80
Wild animals
1.           In the event of suspicion or official
confirmation of a listed disease referred to in Article 8(1)(b) in wild
animals, the competent authority of the affected Member State shall:
(a)     in the entire territory of the Member
State, area or, zone subject to a compulsory eradication programme provided for
in Article 30(1) for that listed disease, apply the disease control measures
laid down in that compulsory eradication programme;
(b)     in the entire territory of the Member
State, area or zone that is not subject to a compulsory eradication programme provided
for in Article 30(1) for that listed disease, initiate that compulsory
eradication programme and apply the disease control measures laid down therein where
appropriate, to control and prevent its spread.
2.           In the event of an outbreak of a listed
disease referred to in Article 8(1)(c) in wild animals the competent authority of
the affected Member State shall:
(a)     in the entire territory of the Member
State, area, zone or compartment subject to a voluntary eradication programme provided
for in Article 30(2) for that listed disease, apply the disease control
measures laid down in that voluntary eradication programme;
(b)     in the entire territory of the a
Member State, area, zone or compartment that is not subject to an voluntary eradication
programme provided for in Article 30(2) for that listed disease, apply, when
appropriate, measures to control and prevent its spread.
3.           The disease control measures
referred to in paragraph 2(b) shall take the following matters into account:
(a)     the disease profile; 
(b)     the affected wild animals; 
(c)     the disease control measures to be
taken in the event of suspicion or official confirmation of a listed disease in
restricted zones in kept animals pursuant to rules laid down in Sections 1 to 4
of Chapter 1 of this Title. 
4.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed
rules supplementing the disease control measures to be taken in the event of
outbreaks of a listed disease referred to in Article 8(1)(b) or (c) in wild
animals as provided for in paragraph 2(b) of this Article.
Section 5
Coordination by the Commission and temporary special disease control rules
Article 81
Coordination of measures by the Commission and temporary special rules
concerning Sections 1 to 4
1.           Member States shall inform the
Commission of the disease control measures taken by the competent authority in
respect of a listed disease referred to in Article 8(1)(b) or (c), in accordance
with Article 76(1), Articles 77 and 78 and Article 80(1) and (2) and
delegated acts adopted pursuant to Article 76(2), Article 79 and Article 80(4).

2.           The Commission shall review the
disease situation and the disease control measures taken by the competent
authority in accordance with this Chapter and may, by means of implementing
acts, lay down special rules for disease control measures for a limited period
of time in respect of a listed disease referred to in Article 8(1)(b) and (c),
under conditions appropriate to the epidemiological situation, where:
(a)     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 taken in accordance with this Chapter, where relevant.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
3.           On duly justified imperative
grounds of urgency relating to a listed disease referred to in Article 8(1)(b)
and (c) representing an emerging risk of highly significant impact the
Commission shall adopt immediately applicable implementing acts in accordance
with the procedure referred to in Article 255(3).
PART IV
REGISTRATION, APPROVAL, TRACEABILITY AND MOVEMENTS
TITLE I
Terrestrial animals, germinal products and products of animal origin from
terrestrial animals
Chapter 1
Registration, approval, record keeping and registers
Section 1
Registration of establishments and transporters
Article 82
Obligation of operators to register establishments 
1.           Operators of establishments keeping terrestrial animals or
collecting, producing, processing or storing germinal products shall, in order
to be registered in accordance with Article 88, before they commence such
activities: 
(a)     inform the competent authority of any such
establishment under their responsibility;
(b)     provide the competent authority with
information on:
(i)      the name and address of the operator;
(ii)      the location and a description of
the facilities;
(iii)     the categories, species and numbers
of kept terrestrial animal or germinal products on the establishment and the
capacity of the establishment;
(iv)     the type of establishment;
(v)     other aspects of the establishment,
which are relevant in determining the risk posed by it. 
2.           Operators of establishments
referred to in paragraph 1 shall inform the competent authority of any:
(a)     significant changes in the
establishment concerning the matters referred to in paragraph 1(b);
(b)     cessation of activity in the
establishment.
3.           Establishments which are subject
to approval in accordance with Article 89(1) shall not be required to provide
the information referred to in paragraph 1 of this Article.
Article 83
Derogations from the obligation of operators to register establishments 
By way of derogation from Article 82(1),
Member States may exempt certain categories of establishments from the
registration requirement, taking into account the following criteria:
(a)          the categories, species and
numbers of kept 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
animals or germinal products into and out of the establishment. 
Article 84
Implementing powers concerning the obligation of operators to register
establishments
The Commission may, by means of
implementing acts, lay down rules concerning:
(a)          the information to be provided by
operators for the purpose of the 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 and delegated acts
1.           Transporters of kept ungulates,
transporting those animals between Member States shall in order to be
registered in accordance with Article 88, before they commence such activities:

(a)     inform the competent authority of
their activity;
(b)     provide the competent authority with
information on:
(i)      the name and address of the
transporter;
(ii)      the categories, species and numbers
of kept terrestrial animals transported;
(iii)     the type of transport;
(iv)     the means of transport. 
2.           Transporters shall inform the
competent authority of any:
(a)     significant changes concerning the
matters referred to in paragraph 1(b);
(b)     cessation of the transport activity.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning supplementing
and amending the rules provided for in paragraph 1 concerning the obligation of
other types of transporters to provide the information for the purposes of
registration of its activity, taking into account the risks involved with such
transports.
Article 86
Derogations from the obligation to register transporters of kept ungulates 
By way of derogation from Article 85(1),
Member States may exempt certain categories of transporters from the
registration requirement, taking into account the following criteria:
(a)          the distances over which they
transport those kept terrestrial animals; 
(b)          the categories, species and
number of kept terrestrial animals, which they transport.
Article 87
Implementing acts concerning the obligation to register transporters
The Commission shall be empowered to adopt implementing
acts concerning:
(a)          the information to be provided by
the transporter 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 the criteria provided for in that Article.

Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Article 88
Obligation of the competent authority concerning the registration of
establishments and transporters
The competent authority shall register: 
(a)          establishments in the register of
establishments and transporters provided for in Article 96(1), where the
operator has provided the information required in accordance with Article
82(1);
(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 establishments and delegated acts
1.           Operators of the following types
of establishments shall apply to the competent authority for approval in
accordance with Article 91(1) and they shall not commence their activities
until their establishment has been approved in accordance with Article 92(1):
(a)     establishments for assembly operations
of ungulates and poultry, from which those animals are moved to another Member
State; 
(b)     germinal product establishments for bovine,
porcine, ovine, caprine and equine animals, from which germinal products of
those animals are moved to another Member State;
(c)     hatcheries, from which hatching eggs
or poultry are moved to another Member State;
(d)     establishments keeping poultry, from
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 accordance
with paragraph 3(b) of this Article.
2.           Operators shall cease activity at
an establishment 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, granted
in accordance with Article 94(3), the establishment fails to comply with the
outstanding requirements referred to in Article 94(3) and does not obtain a
final approval in accordance with Article 92(1). 
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning supplementing
and amending the rules for the approval of establishments provided for in
paragraph 1 of this Article concerning:
(a)     derogations from the requirement for
operators of the types of establishments referred to in paragraph 1(a) to (d) to
apply to the competent authority for approval by the competent authority, where
those establishments pose an insignificant risk;
(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 terrestrial
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
animals or germinal products into and out of those types of establishments.
Article 90
Approval of status of confined establishments 
Operators of establishments, who want to
obtain the status of confined establishment shall:
(a)          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 establishment obtains an approval of that status by the competent
authority in accordance with Articles 92 and 94. 
Article 91
Information obligation of operators in view to obtaining approval and
implementing acts
1.           Operators shall for the purposes of
their application for the approval of their establishment provided for in
Article 89(1) and Article 90(a), provide the competent authority with
information on:
(a)     the name and address of the operator;
(b)     the location of the establishment and a
description of the facilities;
(c)     the categories, species and numbers of
kept terrestrial animals or germinal products on the establishment;
(d)     the type of establishment;
(e)     other aspects of the establishment,
related to its specificity, which are relevant in determining the risk posed by
it. 
2.           Operators of establishments
referred to in paragraph 1 shall inform the competent authority of any:
(a)     significant
changes in the establishments concerning the matters referred to in paragraph 1(a),
(b) and (c);
(b)     the cessation of activity in the
establishment.
3.           The Commission may, by means of implementing
acts, lay down rules concerning the information to be provided by the operators
in their application for the approval of their establishment in accordance with
paragraph 1 of this Article. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Article 92
Granting of and conditions for approval of establishments and delegated acts
1.           The competent authority shall
only grant approval of establishments as provided for in Article 89(1) and
Article 90(a) where such establishments:
(a)     comply with the following
requirements, where appropriate, on: 
(i)      quarantine, isolation and other
biosecurity measures taking into account the requirements provided for in
Article 9(1)(b) and rules adopted pursuant to Article 9(2); 
(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 pursuant to Article 24; 
(iii)     record keeping provided for in
Articles 97 and 98 and the rules adopted pursuant to Articles 100 and 101;
(b)     have facilities and equipment that are:
(i)      adequate to reduce the risk of the introduction
and spread of diseases to an acceptable level, taking into account the type of
establishment;
(ii)      of adequate capacity for the number
of kept terrestrial animals or volume of germinal products;
(c)     do not pose an unacceptable risk
regarding the spread of diseases, taking into account the risk mitigation
measures in place; 
(d)     have a sufficient number of adequately
trained personnel for the activity of the establishment;
(e)     have a system in place which enables
the operator to demonstrate compliance with points (a) to (d) to the competent
authority. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the requirements
provided for in paragraph 1 of this Article as regards:
(a)     quarantine, isolation and other
biosecurity measures referred to in paragraph 1(a)(i);
(b)     surveillance referred to in paragraph
1(a)(ii);
(c)     facilities and equipment referred to
in paragraph 1(b);
(d)     responsibilities, competence and
training of personnel and veterinarians provided for in paragraph 1(d);
(e)     the necessary supervision and control
by the competent authority.
3.           The Commission shall take into
account the following matters when establishing the rules to be laid down in
the delegated acts to be adopted pursuant to paragraph 2:
(a)     the risks posed by each type of
establishment;
(b)     the categories and species of kept
terrestrial animals;
(c)     the type of production;
(d)     typical movement patterns of the type
of establishment and species and categories of animals kept in those
establishments.
Article 93
Scope of the approval of establishments
The competent authority shall expressly specify
in the approval of an establishment granted pursuant to Article 92(1) following
an application made in accordance with Article 89(1) and Article 90(a):
(a)          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 approval by the competent authority 
1.           The competent authority shall establish
procedures for operators to follow when applying for approval of their
establishments in accordance with Articles 89(1), Article 90 and Article 91(1).
2.           Upon receipt of an application
for approval from an operator, the competent authority shall, in accordance
with Article 89(1)(a) and Article 90(a) make an on-site visit.
3.           The competent authority may grant
conditional approval of an establishment where it appears, based on the
application of the operator and the subsequent on-site visit of the establishment
by the competent authority as provided for in paragraph 2 of this Article, that
it meets all the main requirements that provide sufficient guarantees that such
an establishment does not represent a significant risk, with a view to ensuring
compliance with all the requirements for approval provided for in Article 92(1)
and the rules adopted pursuant to Article 92(2). 
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 operator is not able to provide adequate guarantees that
those deficiencies will be resolved, the competent authority shall initiate
procedures to withdraw the establishment's approval. 
However, the competent authority may suspend an
establishment's approval where the operator can guarantee that it will resolve
those deficiencies within a reasonable period of time.
3.           Approval shall only be restored after
withdrawal or suspension in accordance with paragraph 2 when the competent
authority is satisfied that the establishment fully complies with all the
requirements of this Regulation appropriate for that type of establishment. 
Section 3
register of the competent authority of establishments and transporters
Article 96
Establishment and transporter register
1.           The
competent authority shall establish 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 adopt delegated acts in accordance with Article 253 concerning: 
(a)     the information to be included in the
register provided for in paragraph 1;
(b)     additional requirements for registers
of germinal products establishments, after they cease activities; 
(c)     public availability of the register
provided for in paragraph 1.
4.           The Commission may, by means of
implementing acts, lay down rules on the format of and procedures for the
register of establishments and transporters and approved establishments provided
for in paragraph 1 of this Article.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Section 4
Record keeping
Article 97
Record keeping obligations of operators of establishments other than germinal
products establishments 
1.           Operators of establishments
subject to registration in accordance with Article 88, or approval in
accordance with Article 92(1) shall keep and maintain records containing at
least the following information:
(a)     the species, categories, numbers and
identification of kept terrestrial animals on their establishment;
(b)     the movements of kept terrestrial
animals into and out of their establishment, stating as appropriate:
(i)      their place of origin or destination;

(ii)      the date of such movements;
(c)     the documents in paper or electronic
form required to accompany kept terrestrial animals arriving at or leaving their
establishment in accordance with Articles 106(b), 107(b), 109(c), 110(b), 113(b),
Article 140(1) and (2), Article 162(2) and rules adopted pursuant to Articles
114 and 117 and Article 141(1)(b) and (c);
(d)     any animal health problems concerning
kept animals on their establishment;
(e)     biosecurity measures, surveillance,
treatments, test results and other relevant information as appropriate for: 
(i)      the category and species of kept
terrestrial animals on the establishment; 
(ii)      the type of production;
(iii)     the type and size of the
establishment;
(f)      the results of any animal health
visits required in accordance with Article 23(1) and rules adopted pursuant to
Article 24.
2.           Establishments which are exempted
from the registration requirement in accordance with Article 83 may be exempted
by the Member State from the requirement to keep records of the information
listed in paragraph 1 of this Article.
3.           Operators of establishments shall
keep the records provided for in paragraph 1 on the establishment and:
(a)     make them available to the competent
authority on request;
(b)     retain them for a minimum period to be
determined by the competent authority, but which may not be less than a period
of three years.
Article 98
Record keeping for germinal product establishments
1.           Operators of germinal product establishments
shall keep and maintain records containing at least the following information:
(a)     the breed, age and identification of
donor animals used for the production of germinal products;
(b)     the time and place of collection,
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 Member State from the requirement to keep records of the information
listed in paragraph 1 of this Article.
3.           The operators of germinal product
establishments shall keep the records provided for in paragraph 1 on the
establishment and: 
(a)     make them available to the competent
authority on request; 
(b)     retain them for a minimum period to be
determined by the competent authority, but which may not be less than a period
of three years.
Article 99
Record keeping for transporters
1.           Transporters of germinal products
shall keep and maintain records containing at least the following information:
(a)     the establishments visited by them; 
(b)     the categories, species and number of germinal
products transported by them;
(c)     the cleaning, disinfection and disinfestation
of the means of transport.
2.           Transporters which are exempted
from the registration requirement in accordance with Article 86 may be exempted
by the Member State from the requirement to keep records of the information
listed in paragraph 1 of this Article.
3.           Transporters shall keep the
records provided for in paragraph 1: 
(a)     in a manner that they can be made
immediately available to the competent authority on request. 
(b)     for a minimum period to be determined
by the competent authority, but which may not be less than a period of three
years.
Article 100
Delegation of powers concerning record keeping
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning rules
supplementing the record keeping requirements provided for in Articles 97, 98
and Article 99, as regards:
(a)     derogations from the record keeping
requirements for: 
(i)      operators of certain types of
establishments and certain types of transporters;
(ii)      establishments keeping, or
transporters handling a small number of kept terrestrial animals or small
volume of germinal products;
(iii)     certain categories or species of
kept terrestrial animals or germinal products;
(b)     information to be recorded in addition
to that provided for in Articles 97(1), 98(1) and 99(1); 
(c)     additional requirements for record
keeping for germinal products collected, produced or processed in a germinal
products establishment, after they ceased their activities.
2.           The Commission shall take into
account the following matters when establishing the rules to be laid down in
delegated acts provided for in paragraph 1:
(a)     the risks posed by each type of
establishment or transporter;
(b)     the categories and species of kept
terrestrial animals or germinal products in the establishment or transported;
(c)     the type of production on the
establishment or the type of transport;
(d)     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 implementing
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 pursuant to Article 100;
(c)          procedures for record keeping provided for in Articles
97(1), 98(1) and 99(1) and rules adopted pursuant to Article 100.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Chapter 2
Traceability requirements for kept terrestrial animals and germinal products
Section 1
kept terrestrial animals
Article 102
Member States' responsibility for establishing a system for the identification
and registration of kept terrestrial animals
1.           The Member States shall have in
place a system for the identification and registration of kept terrestrial
animals and, when appropriate, for the recording of their movements, taking
into account:
(a)     the species or category of kept
terrestrial animals; 
(b)     the risk posed by that species or
category.
2.           The system provided for in paragraph
1 shall include the following elements:
(a)     the means
to identify kept terrestrial animals individually or in groups;
(b)     identification documents, movement
documents and other documents for identifying and tracing kept terrestrial
animals referred to in Article 104;
(c)     up-to-date records in establishments
as provided for Article 97(1)(a) and (b); 
(d)     a computer database of kept
terrestrial animals provided for in Article 103(1). 
3.           The system provided for in
paragraph 1 shall be designed in a manner that it:
(a)     ensures the efficient application of
the 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 interoperability,
integration and compatibility of the elements of that system;
(d)     ensures that the system, to the extent
appropriate, is adapted to:
(i)      the computerised information system
for Union notification and reporting provided for in Article 20; 
(ii)      IMSOC; 
(e)     ensures a coherent approach for the
different animal species covered by the system. 
4.           Member States may when
appropriate: 
(a)     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 Article 140(1) and (2) and Article 148(1) and rules adopted pursuant to
Article 141(b) and (c) and Article 148(3) and (4);
(c)     designate another authority or
authorise another body or a natural person for the practical application of the
identification and registration system provided for in paragraph 1. 
Article 103
Member States obligation for establishing a computer database of kept
terrestrial animals
1.           The Member States shall establish
and maintain a computer database, for the recording of: 
(a)     the following information related to kept
animals of the bovine, ovine and caprine species:
(i)      their individual identification as
provided for in Articles 106(a) and 107(a); 
(ii)      the establishments keeping them;
(iii)     their movements into and from establishments;

(b)     information related to kept animals 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 provided
for in Article 109(1)(a);
(ii)      the means of identification linking
that animal with the identification document referred to in (iii), where
relevant; 
(iii)     the identification document provided
for in Article 109(1)(c);
(iv)     the establishments where those
animals are habitually kept;
(d)     information related to kept
terrestrial animals of species other than those referred to in (a), (b) and
(c), when this is provided for in rules adopted pursuant to paragraph 2.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the recording
of information related to animal species other than those referred to in paragraph
1(a),(b) and (c) of this Article, in the computer database provided for in that
paragraph where necessary, taking into account the risks posed by those
species, to:
(a)     ensure the efficient application of
the disease prevention and control measures provided for in this Regulation;
(b)     facilitate the traceability of kept
terrestrial animals, their movements within and between Member States and their
entry into the Union. 
Article 104
Obligation of the competent authority for identification documents, movement
documents and other documents for identifying and tracing kept terrestrial
animals
The competent
authority shall issue:
(a)          identification documents for kept
terrestrial animals when required by Articles 106(b) and 109(c), Article 112(1)(b)
and (2)(b), and Article 113(b) and rules adopted pursuant to Articles 114 and
117;
(b)          movement documents and other
documents for identifying and tracing kept terrestrial animals, when required
by Articles 107(b), 110(b), 113(b) and rules adopted pursuant to Articles 114
and 117.
Article 105
Public availability of information on means of identification
The competent authority shall inform the
Commission and make publicly available information on:
(a)          contact points for the computer databases established
by the Member States in accordance with Article 103(1);
(b)          the authorities or bodies responsible for issuing
identification documents, movement documents and other documents in accordance
with Article 104, taking into account Article 102(4)(c);
(c)          the means of identification that are to be used for
each category and species of kept terrestrial animals in accordance with
Articles 106(a) and 107(a), Article 109(1), Article 110(a), Article 112(1)(a)
and (2)(a) and Article 113(a) and rules adopted pursuant to Articles 114 and
117;
(d)          the prescribed format for the issuing of the
identification documents and other documents referred to in Article 104.
Article 106
Operators obligations for the identification of kept animals of the bovine
species
Operators keeping animals of the bovine
species shall:
(a)          ensure that those kept animals
are identified individually by a physical means of identification; 
(b)          ensure that those kept animals are
issued with an identification document from the competent authority or
designated authority or authorised body, which is a single lifetime document
and that that document: 
(i)      is kept, correctly completed and
updated by the operator;
(ii)     accompanies those kept terrestrial animals
at the time of movement;
(c)          transmit the information on
movements of those kept animals from and into the establishment to the computer
database provided for in Article 103(1) and the rules adopted pursuant to
Articles 114 and 117. 
Article 107
Operators obligations for the identification of kept animals of the ovine and
caprine species
Operators keeping kept animals of the ovine
and caprine species shall:
(a)          ensure that those kept animals
are identified individually by a physical means of identification; 
(b)          ensure that those kept animals
are accompanied by a correctly completed movement document issued by the
competent authority in accordance with Article 104 when moved from the
establishment keeping those animals;
(c)          transmit the information on
movements from and into the establishment of those kept animals to the computer
database provided for in Article 103(1) and the rules adopted pursuant to
Articles 114 and 117. 
Article 108
Derogations concerning identification documents and movement documents for kept
animals of the bovine, ovine and caprine species 
By way of derogation from Article 104 and
from Articles 106(b) and 107(b), Member States may exempt operators from the
requirement to ensure that kept animals of the bovine, ovine and caprine
species are accompanied by identification documents or movement documents during
movements within the Member State, provided that:
(a)          the information contained in the
movement document or identification document is included in the computer
database provided for in Article 103(1);
(b)          the system for the identification
and registration of kept animals of the bovine, ovine and caprine species
provides an equivalent level of traceability as that provided by identification
documents and movements documents.
Article 109
Operators obligations for the identification and registration of kept animals
of the equine species
1.           Operators keeping kept animals of
the equine species shall ensure that those animals are individually identified
by:
(a)     an unique life number, which is
recorded in the computer database provided for in Article 103(1);
(b)     a method which unequivocally links the
kept animal and with the identification document provided for in point (c) of this
paragraph and issued by the competent authority in accordance with Article 104;

(c)     a correctly completed single lifetime
identification document.
2.           Operators of kept animals of the
equine species shall transmit the information on those animals to the computer
database provided for in Article 103(1) and by the rules adopted pursuant to
Articles 114 and 117. 
Article 110
Operators obligations for the identification and registration of kept l animals
of the porcine species
Operators keeping kept animals of the
porcine species shall:
(a)          ensure that those kept animals
are identified by a means of physical identification; 
(b)          ensure that those kept animals
are accompanied by a correctly completed movement document issued by the
competent authority in accordance with Article 104(b) when moved from the
establishment keeping those animals;
(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 may exempt operators from the requirement to ensure that kept
animals of the porcine species are accompanied by correctly completed movement
documents issued by the competent authority for movements within the Member
State, provided that:
(a)          the information on such movement
documents 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 level of traceability as that provided by such movement documents.
Article 112
Pet keepers' obligation for the identification and registration of terrestrial pet
animals
1.           Pet keepers shall ensure that terrestrial
pet animals of the species listed in Part A of Annex I which are moved from one
Member State to another Member State:
(a)     are individually identified by a
physical means of identification;
(b)     are accompanied by a correctly
completed and updated identification document issued by the competent authority
in accordance with Article 104.
2.           Pet keepers shall ensure that terrestrial
pet animals of the species listed in Part B of Annex I when moved from one
Member State to another Member State, and when required by rules adopted
pursuant to Articles 114 and 117, are:
(a)     identified, either individually or in
groups;
(b)     accompanied by correctly completed and
updated identification documents, movement documents or other documents for
identifying and tracing animals, as appropriate for the animal species
concerned.
Article 113
Operators obligation for the identification of kept terrestrial animals other
than animals of the bovine, ovine, caprine, porcine and equine species and pet
animals
Operators shall ensure that kept
terrestrial animals of species other than those of the bovine, ovine, caprine,
porcine and equine species and other than pet animals, comply with the
following requirements, when required by the rules adopted pursuant to Articles
114 and 117:
(a)          they are identified, either
individually or in groups;
(b)          they are accompanied by correctly
completed and updated identification documents, movement documents or other
documents for identifying and tracing animals, as appropriate for the animal
species concerned.
Article 114
Delegation of powers concerning identification and registration
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning:
(a)          the designation of other
authorities, the authorisation of bodies or natural persons, as provided for in
Article 102(4)(c); 
(b)          detailed requirements for: 
(i)      the means of identification of kept
terrestrial animals provided for in Articles 106(a) and 107(a), Article 109(1),
Article 110(a), Article 112(1)(a) and (2)(a), and Article 113(a); 
(ii)     the application and use of that means
of identification;
(c)          the information to be included
in: 
(i)      the computer databases provided for
in Article 103(1);
(ii)     the identification document for kept
animals of the bovine species provided for in Article 105(b);
(iii)     the movement document for kept
animals of the caprine and ovine species provided for in Article 107(b);
(iv)    the identification document for kept animals
of the equine species provided for in 109(1)(c);
(v)     the movement document for kept animals
of the porcine species provided for in Article 110(b);
(vi)    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 animals 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 identification and registration 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
requirements for kept terrestrial pet animals of the species listed in Part B
of Annex I and kept terrestrial animals of species other than the bovine,
ovine, caprine, porcine and equine species where necessary, taking into account
the risks posed by that species, to:
(i)      ensure the efficient application of
the disease prevention and control measures provided for in this Regulation;
(ii)     facilitate the traceability of kept
terrestrial animals, and their movements within and between Member States and
their entry into the Union.
Article 115
Delegation of powers concerning derogations from the traceability requirements
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning derogations for
operators from the identification and registration requirements provided for in
Articles 106, 107 and 109 and 110:
(a)          in cases where one or more of
these elements are not necessary to meet the requirements provided for in
Article 102(3)(a) and (b); 
(b)          when other traceability measures
in place in the Member States guarantee that the level of traceability of the
animals in questions is not compromised.
Article 116
Matters to be taken into account when adopting delegated acts provided for in Articles
114 and 115
The Commission shall take the following
matters into account, when establishing the rules to be laid down in the
delegated acts provided for in Articles 114 and 115:
(a)          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 categories of kept terrestrial animals; 
(f)           considerations concerning the
protection and conservation of species of kept terrestrial animals; 
(g)          the performance of the other
traceability elements of the system for the identification and registration of
kept terrestrial animals referred to in Article 102(2).
Article 117
Implementing powers concerning traceability of kept terrestrial animals
The Commission shall by means of
implementing acts, lay down rules for the implementation the requirements provided
for in Articles 106, 107, 109, 110, 112 and 113 and those laid down in delegated
acts adopted pursuant to Article 103(2) and Articles 114 and 115
concerning:
(a)          technical specifications, formats
and operational rules of: 
(i)      means, methods and the use of
identification;
(ii)     the identification document or movement
document for kept animals of the bovine, ovine, caprine species;
(iii)     identification document for kept animals
of the equine species;
(iv)    identification, movement and other
documents for kept terrestrial animals of species; other than of the bovine,
ovine, caprine and equine species
(v)     computer databases.
(b)          the deadlines for: 
(i)      the transmission of information by
operators into the computer database; 
(ii)     the registration of kept 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 germinal products of kept animals of the bovine,
ovine, caprine, equine and porcine species and poultry
1.           Operators producing, processing
or storing germinal products shall mark germinal products of kept animals of
the bovine, caprine, ovine, equine and porcine species in such a way that they
can be clearly traced to:
(a)     the donor animals;
(b)     the date of collection; 
(c)     the germinal product establishments where
they were collected, produced, processed and stored. 
2.           The marking provided for in
paragraph 1 shall be designed in such a way as to ensure:
(a)     the efficient application of the
disease prevention and control measures provided for in this Regulation; 
(b)     the traceability of the germinal
products and their movements within and between Member States and their entry
into the Union.
Article 119
Delegation power concerning traceability requirements for germinal products 
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     traceability requirements for germinal
products of kept terrestrial animals of the bovine, caprine, ovine, porcine and
equine species amending and supplementing the rules laid down in Article 118;
(b)     traceability requirements for germinal
product of kept terrestrial animals of species other than of the bovine,
caprine, ovine, equine and porcine species, where necessary for: 
(i)      the efficient application of the
disease prevention and control measures provided for in this Regulation; 
(ii)      the traceability of those germinal
products, their movements within and between Member States and their entry into
the Union.
2.           The Commission shall take the
following matters into account when adopting the delegated acts provided for in
paragraph 1:
(a)     the species of kept terrestrial
animals from which the germinal products originate;
(b)     the health status of donor animals;
(c)     the risk involved with such germinal
products;
(d)     the type of germinal products;
(e)     the type of collection, processing or
storage; 
(f)      movement patterns for the species and
categories of kept terrestrial animals and their germinal products; 
(g)     considerations concerning the
protection and conservation of species of kept terrestrial animals;
(h)     other elements that may contribute to
the traceability of germinal products.
Article 120
Implementing powers concerning traceability requirements for germinal products 
The Commission shall, by means of
implementing acts, lay down rules concerning: 
(a)          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). 
Chapter 3
Movements within the Union of kept terrestrial animals other than
terrestrial pet animals
Section 1
General requirements for movements
Article 121
General requirements for movements of kept terrestrial animals
1.           Operators shall take appropriate
preventive measures to ensure that the movement of kept terrestrial animals
does not jeopardise the health status at the place of destination with regard
to: 
(a)     the listed diseases referred to in
Article 8(1)(d); 
(b)     emerging diseases.
2.           Operators shall only move kept
terrestrial animals from establishments and receive such animals, if they
comply with the following conditions:
(a)     they come from establishments that
have been:
(i)      entered in the register of
establishments by the competent authority in accordance with Article 88(a) and
no derogation has been granted by the Member State of origin in accordance with
Article 83; 
(ii)      approved by the competent authority
in accordance with Article 92(1), when required by Article 89(1) or Article 90;

(b)     they comply with the identification
and registration requirements of Articles 106, 107, 109, 110 and 113 and the
rules adopted pursuant to Article 114(a) to (d) and Article 117.
Article 122
Preventive measures in relation to transport
1.           Operators shall take the
appropriate and necessary preventive measures to ensure that:
(a)     the health status of kept terrestrial
animals is not jeopardised during transport;
(b)     transport operations of kept
terrestrial animals do not cause the potential spread of listed diseases referred
to in Article 8(1)(d) to humans and animals at places of assembly, resting and
destination; 
(c)     cleaning, disinfection,
disinfestations of equipment and means of transport and other adequate
biosecurity measures are taken, as appropriate to the risks involved with the
transport.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     the cleaning, disinfection and
disinfestations of equipment and means of transport and the use of biocidal
products for those purposes;
(b)     other adequate biosecurity measures as
provided for in paragraph 1(c). 
Section 2
Movements between Member States 
Article 123
General requirements for movements of kept terrestrial animals between Member
States
1.           Operators shall only move kept
terrestrial animals to another Member State if they comply with following
conditions:
(a)     they come from an establishment: 
(i)      where there are no abnormal
mortalities or other disease symptoms with an undetermined cause;
(ii)      which is not subject to movement
restrictions affecting the species to be moved in accordance with the rules
laid down in Articles 55(1)(d), 61(1)(a), Article 62, Article 65(1)(c), Article
74(1) and Article 78(1) and (2) and the rules adopted pursuant to Article 55(2),
Articles 63 and 67, Article 71(3), Article 74(3), Article 79 and Article 81(2) or
the emergency measures provided for in Articles 246 and 247 and rules adopted
pursuant to Article 248, unless derogations have been granted for movement
restrictions in accordance with those rules; 
(iii)     which is not situated in a
restricted zone in accordance with rules laid down in Article 55(1)(f)(ii), Articles
64 and 65, Article 74(1), Article 78 and rules adopted pursuant to Article 67, Article
71(3), Article 74(3), Article 79 and Article 81(2) or the emergency measures provided
for in Articles 246 and 247 and rules adopted pursuant to Article 248, unless
derogations have been granted in accordance with those rules; 
(b)     they have not been in contact with
kept terrestrial animals subject to movement restrictions referred to in point
(a)(ii) and (iii) or kept terrestrial animals of a listed species of a lower
health status, for an adequate period of time, prior to the date of the
intended movement to another Member State, thereby minimising the possibility
of spreading disease, taking into account the following matters:
(i)      the incubation period and routes of
transmission of the listed diseases and emerging diseases; 
(ii)      the type of establishment;
(iii)     the species and category of kept
terrestrial animals moved; 
(iv)     other epidemiological factors;
(c)     they comply with the relevant
requirements provided for in Sections 3 to 8.
2.           Operators shall take all
necessary measures to ensure that kept terrestrial animals moved to another
Member State are consigned directly to their place of destination in another
Member State unless they need to stop at a place of resting for animal welfare
reasons.
Article 124 
Obligations of operators at the place of destination
1.           Operators of establishments and
slaughterhouses receiving kept terrestrial animals from another Member State
shall: 
(a)     check that: 
(i)      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 documents provided
for in Articles 106(b) and 107(b), Article 109(1)(c), Article 113(b) and the rules
adopted pursuant to Articles 114 and 117 are present and are correctly
completed; 
(b)     check that the animal health certificates
provided for in Article 140 and rules adopted pursuant to Article 141(b) and
(c) or the self-declaration documents provided for in Article 148 and the rules
adopted pursuant to Article 148(2) are present; 
(c)     inform the competent authority of any
irregularity with regard to: 
(i)      the kept terrestrial animals received;
(ii)      the presence of the means of
identification referred to in point (a)(i);
(iii)     the documents referred to in point
(a)(ii) and (b).
2.           In the event of any irregularity
as referred to in paragraph 1(c), the operator shall isolate the animals concerned
by that irregularity until the competent authority has taken a decision
regarding them.
Article 125 
Prohibition on movements of kept terrestrial animals between Member States
Operators shall not move kept terrestrial
animals to another Member State, unless the Member State of destination gives
express authorisation prior to the movement in the event of animals which are
intended to be slaughtered for disease eradication purposes as a part of an
eradication programme provided for in Article 30(1), (2) and (3).
Article 126
General requirements for operators for movements of kept terrestrial animals passing
through Member States but intended for export from the Union to third countries
or territories
Operators shall ensure that kept
terrestrial animals intended for export to a third country or territory and passing
through the territory of another Member State fulfil the requirements laid down
in Articles 121, 122, 123 and 125. 
Section 3
Specific requirements for movements
to other Member States of ungulates and poultry
Article 127
Movement of kept ungulates and poultry to other Member States
Operators shall only move kept ungulates and
poultry from an establishment in one Member State to another Member State if
they comply with following conditions as regards the listed diseases referred
to in Article 8(1)(d):
(a)          they show no clinical symptoms or signs of listed
diseases referred to in Article 8(1)(d) at the time of movement;
(b)          they have been subject to a residency period
appropriate to those listed diseases taking into account the species and
category of kept ungulates and poutry to be moved;
(c)          for a period of time appropriate for those listed
diseases and the species and category of ungulates or poultry to be moved, no
kept ungulates or poultry have been introduced into the establishment of
origin;
(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 ungulates and poultry to other Member
States
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     residency periods provided for in
Article 127(b);
(b)     the period of time necessary for
limiting the introduction of kept ungulates or poultry into establishments
prior to movement provided for in Article 127(c);
(c)     supplementary requirements to ensure
that the kept ungulates and poultry do not pose a significant risk for the
spread of listed diseases referred to in Article 8(1)(d), as provided for in
Article 127(d); 
(d)     other risk mitigating measures amending
and supplementing the requirements laid down in Article 127. 
2.           The Commission shall take the
following matters into account, when establishing the rules to be laid down in
the delegated acts provided for in paragraph 1: 
(a)     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
diseases referred to in Article 8(1)(d) at the establishments, compartments,
zones and Member States of origin and destination; 
(c)     the type of establishment and the type
of production at the places of origin and destination;
(d)     the type of movement; 
(e)     the categories and species of kept
ungulates or poultry to be moved; 
(f)      the age of the kept ungulates or
poultry to be moved;
(g)     other epidemiological factors.
Article 129
Kept ungulates and poultry moved to another Member State and intended for
slaughter
1.           Operators of slaughterhouses
receiving kept ungulates and poultry from another Member State shall slaughter
those animals as soon as possible following their arrival and at the latest within a timeframe to be laid down in delegated acts
adopted pursuant to paragraph 2.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the time of
slaughter provided for in paragraph 1 of this Article.
Section 4 
Assembly operations for kept ungulates and poultry
Article 130
Derogation for assembly operations
1.           By
way of derogation from Article 123(2), operators may subject kept ungulates and
poultry to a maximum of: 
(a)     one assembly operation in the Member
State of origin;
(b)     one assembly operation in the Member
State of passage; 
(c)     one assembly operation in the Member
State of destination. 
2.           The assembly operations provided
for in paragraph 1 of this Article shall only take place in an establishment
approved for that purpose in accordance with Article 92(1) and Article 94(3)
and (4). 
However, the Member State of origin may allow
assembly operations in their territory to take place on means of transport,
collecting kept ungulates and poultry directly from their establishments of
origin, provided that they are not unloaded again following those operations before:

(a)     arriving at their establishment or final
place of destination; or 
(b)     an assembly operation provided for in
paragraph 1(b) and (c).
Article 131
Disease prevention requirements for assembly operations
Operators conducting assembly operations
shall ensure that:
(a)          the kept ungulates and poultry
assembled are of the same health status or where they are not of the same
health status, the lower health status shall apply to all such animals assembled;
(b)          the kept ungulates and poultry are
assembled and moved to their final place of destination in another Member State
as soon as possible after leaving their establishment of origin, and at the
latest within a timeframe to be laid down in
delegated acts adopted pursuant to Article 132(c); 
(c)          the necessary biosecurity
measures are taken to ensure that the kept ungulates and poultry assembled:
(i)      do not come into contact with kept
ungulates or poultry of a lower health status; 
(ii)     do not pose a significant risk for
the spread of the listed diseases referred to in Article 8(1)(d) to the kept
ungulates or poultry at the place of the assembly operation; 
(d)          the kept ungulates or poultry are
identified and, where required, accompanied with the following documents:
(i)      the identification and registration
documents where provided for in Articles 106(b), 107(b), 109(c), 110(b) and
Article113(b) and rules adopted pursuant to Articles 114 and 117, unless
derogations are provided for according to Article 115; 
(ii)     the animal health certificates where
provided for in Article 140 and Article 141(c), unless derogations are provided
for in the rules adopted pursuant to Article 141(a);
(iii)     the self-declaration document where
provided for in Article 148.
Article 132
Delegation of powers concerning assembly operations
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning:
(a)          specific rules for assembly operations, where other
risk mitigating measures, in addition to those provided for in Article 131(b)
and (c), are in place; 
(b)          criteria under which Member States of origin may allow
assembly operations to take place on means of transport, as provided for in the
second subparagraph of Article 130(2); 
(c)          the timeframe between the time of departure of the kept
ungulates or poultry from their establishment of origin and their departure from
the assembly operation to their final destination in another Member State as
referred to in Article 131(b);
(d)          biosecurity measures provided for in Article 131(c). 
Section 5 
Movements to other Member States of kept terrestrial animals other than kept
ungulates and poultry
Article 133
Movement of kept terrestrial animals other than kept ungulates and poultry to
other Member States and delegated acts
1.           Operators shall only move kept
terrestrial animals other than kept ungulates or poultry from an establishment
in one Member State to another Member State if they do not pose a significant
risk for the spread of listed diseases referred to in Article 8(1)(d) at
the place of destination. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed rules
to ensure that the kept terrestrial animals other than kept ungulates or
poultry do not pose a significant risk for the spread of listed diseases referred
to in Article 8(1)(d) provided for in paragraph 1 of this Article.
3.           The Commission shall take the
following matters into account, when establishing the detailed rules to be laid
down in the delegated acts provided for in paragraph 2: 
(a)     the listed diseases referred to in
Article 8(1)(d) relevant for the listed species or the category of kept
terrestrial animals to be moved; 
(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
types of production at the place of origin and the place of destination;
(d)     the types of movement in respect of
the final use of animals at destination; 
(e)     the categories and species of kept
terrestrial animals to be moved; 
(f)      the age of the kept terrestrial
animals to be moved;
(g)     other epidemiological factors.
Section 6
Derogating from and supplementing risk mitigation measures 
Article 134
Animals intended for confined establishments and delegated acts
1.           Operators shall only move kept
terrestrial animals to a confined establishment if they comply with the
following conditions: 
(a)     they originate from another confined
establishment; 
(b)     they do not pose a significant risk
for the spread of listed diseases referred to in Article 8(1)(d) to listed
species or to categories of animals at the confined establishment of destination,
except where such movement is authorised for scientific purposes.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     detailed rules for movements of kept
terrestrial animals into confined establishments in addition to those provided
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 movements do not pose a significant risk for
the health of kept terrestrial animals within that confined establishment and the
surrounding establishments.
Article 135
Derogations for movements of kept terrestrial animals for scientific purposes
and delegated acts
1.           The competent authority of the
place of destination may, subject to the agreement of the competent authority
of the place of origin, authorise movements into the territory of the Member
State of kept terrestrial animals for scientific purposes, which do not comply
with the requirements of Sections 1 to 5, with the exception of Articles 121
and 122, Article 123(1)(a)(ii) and Article 124.
2.           The competent authorities shall
only grant derogations provided for in paragraph 1 under the following
conditions:
(a)     the competent authorities of the place
of destination and origin:
(i)      have agreed on the conditions for
such movements;
(ii)      have taken the necessary risk
mitigating measures to ensure that those movements do not jeopardise the health
status en route and the places of destination with regard to the listed
diseases referred to in Article 8(1)(d); 
(iii)     have notified, where relevant, the
competent authority of Member States of passage of the derogation granted and
the conditions under which it is granted; 
(b)     those movements of those animals take
place under the supervision of the competent authorities of places of origin
and destination, and where relevant, the competent authority of the Member
State of passage. 
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning amending and
supplementing the rules for derogations by the competent authorities provided
for in paragraphs 1 and 2 of this Article. 
Article 136
Derogations concerning recreational use, sporting and cultural events, grazing
and work near borders 
1.           The competent authority of the
place of destination may grant derogations from the requirements of Sections 2 to
5, with the exception of Article 123(a) and (b) and Articles 124 and 125, for intra-Union
movements of kept terrestrial animals between Member States where such
movements are for:
(a)     recreational use near borders; 
(b)     exhibitions, and for sporting,
cultural and similar events organised near borders;
(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 paragraph 1 shall be agreed on between the
Member States of origin and destination and appropriate risk mitigating
measures taken to ensure that such movements do not pose a significant risk.
3.           The Member States referred to in
paragraph 2 shall inform the Commission of the granting of derogations provided
for in paragraph 1. 
4.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning amending and
supplementing the rules for derogations by the competent authority of the place
of destination provided for in paragraph 1 of this Article.
Article 137
Delegation of power concerning derogations for circuses, exhibitions, sporting
events and recreational use, zoos, pet shops, and wholesalers 
The
Commission shall be empowered to adopt delegated acts in accordance with
Article 253 concerning: 
(a)          specific requirements supplementing
the rules laid down in Sections 2 to 5 for the movements of kept terrestrial
animals for the following purposes: 
(i)      circuses, zoos, pet shops, animal
shelters and wholesalers; 
(ii)     exhibitions and for sporting,
cultural and similar events;
(b)          derogations from Sections 2 to 5
with the exception of Article 123(a) and (b) and Articles 124 and 125 for the
movements of kept terrestrial animals referred to in point (a). 
Article 138
Implementing power for temporary derogations for movements of specific species
or categories of kept terrestrial animals
The Commission may,
by means of implementing acts lay down rules concerning temporary derogations from
the rules laid down in this Chapter for movements of specific species or
categories of kept terrestrial animals where:
(a)          the movement requirements
provided for in Article 127, Article 129(1), Articles 130 and131, Articles 133(1),
134(1) and 135(1) and (2) and Article 136 and the rules adopted pursuant to
Articles 128(1) and 129(2), Article 132, Articles 133(2), 134(2), 135(3) and 136(4)
and Article 137 are not effectively mitigating the risks posed by the movement of
such animals; or
(b)          the listed disease referred to in
Article 8(1)(d) appears to be spreading despite the movement requirements laid
down in accordance with Sections 1 to 6.
Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 255(2). 
On duly
justified imperative grounds of urgency relating to diseases representing a
risk of highly significant impact and taking into account the matters referred
to in Article 139 the Commission shall adopt immediately applicable
implementing acts in accordance with the procedure provided for in Article 255(3).
Article 139
Matters to be taken into account when adopting delegated and implementing acts
provided for in this Section
The Commission shall take the following
matters into account, when establishing the rules to be laid down in the
delegated and implementing acts provided for in Articles 134(2), 135(3) and
136(4) and Articles 137 and 138:
(a)          the risks involved with the
movements referred to in those provisions; 
(b)          the health status as regards the
listed diseases referred to in Article 8(1)(d) at the places of origin and
destination;
(c)          listed animal species for the
listed diseases referred to in Article 8(1)(d);
(d)          biosecurity measures in place at
the places 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 species and categories of kept terrestrial animals to another Member
State if they are accompanied by an animal health certificate issued by the
competent authority of the Member State of origin in accordance with Article
146(1):
(a)     ungulates;
(b)     poultry;
(c)     kept terrestrial animals other than
ungulates and poultry, intended for a confined establishment;
(d)     kept terrestrial animals other than
those referred to in points (a), (b) and (c) of this paragraph, when required in
accordance with delegated acts adopted pursuant to Article 141(1)(c).
2.           Operators shall not move kept
terrestrial animals within a Member State or from one Member State to another
Member State unless they are accompanied by an animal health certificate issued
by the competent authority of the Member State of origin in accordance with
Article 146(1), where the conditions referred to in the following points (a)
and (b) are meet: 
(a)     the kept terrestrial animals are allowed
to leave a restricted zone provided for in Article 55(1)(f)(ii), Article 56 and
Article 64(1) and are subject to disease control measures provided for in Articles
55(1), 65(1), 74(1) or Article 78(1) and (2) or rules adopted pursuant to
Article 55(2), Article 67, Articles 71(3) and 74(3), Article 79, Article 81(3)
or Article 248; 
(b)     the kept terrestrial animals are of
species subject to those disease control measures.
3.           Operators shall take all
necessary measures to ensure that the animal health certificate referred to in
paragraph 1 of this Article accompanies the kept terrestrial animals from their
place of origin to their final place of destination, unless specific measures
are provided for in rules adopted pursuant to Article 144.
Article 141
Delegation of powers concerning the obligation of operators to ensure that
animals are accompanied by an animal health certificate
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning: 
(a)     derogations from the animal health certification
requirements provided for in Article 140(1), for movements of kept
terrestrial animals, which do not pose a significant risk for the spread of a disease
due to:
(i)      the species or categories of the kept
terrestrial animals that are being moved and the listed diseases referred to in
Article 8(1)(d) for which they are listed species; 
(ii)      the methods of keeping and the type
of production of those species and categories of kept terrestrial animals;
(iii)     the intended use of the kept
terrestrial animals; 
(iv)     the place of destination of the kept
terrestrial animals; or
(b)     special rules for animal health
certification requirements provided for in Article 140(1) where specific risk
mitigating measures concerning surveillance or biosecurity are taken by the
competent authority, taking into account the matters provided for in paragraph
2 of this Article, which ensure:
(i)      the traceability of the kept
terrestrial animals being moved; 
(ii)      that the kept terrestrial animals
being moved comply with required animal health requirements for movements provided
for in Sections 1 to 6; 
(c)     the requirement for animal health
certification for movements of species and categories of kept terrestrial
animals other than those referred to in Article 140(1)(a)(b) and (c) in
cases where animal health certification is imperative to ensure that the
movement in question complies with the animal health requirements for movements
provided for in Sections 1 to 6. 
2.           When establishing the special
rules provided for in paragraph 1(b), the Commission shall take the following
matters into account:
(a)     the confidence of the competent
authority about the biosecurity put in place by operators as provided for in
Article 9(1)(b) and rules adopted pursuant Article 9(2);
(b)     the capability of the competent
authority to take necessary and appropriate measures and activities required by
this Regulation as provided for in Article 12(1);
(c)     the level of obtained basic knowledge
of animal health as provided for in Article 10 and the support provided 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,
where other relevant surveillance, quality assurance schemes or official
controls as referred to in Article 23(1)(c) are not in place;
(e)     the performance of the Union
notification and reporting as provided for in Articles 17 to 20 and the rules adopted
pursuant to Articles 17(3) and18(3) and Article 21 applied by the competent
authority; 
(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 referred to in paragraph 1(a)(i) to (iv) into account, when
establishing the requirements for animal health certification provided for in
paragraph (1)(c) of this Article.
Article 142
Contents of animal health certificates 
1.           The animal health certificate
shall contain the following information: 
(a)     the establishment or place of origin,
the establishment or place of destination and, where relevant, establishments
for assembly operations or for rests of the kept terrestrial animals;
(b)     a description of kept terrestrial
animals; 
(c)     the number of kept terrestrial
animals;
(d)     the identification and registration of
kept terrestrial animals, where required by Articles 106, 107, 109, 110 and 113
and rules adopted pursuant to Articles 114 and 117, unless derogations are
provided for in accordance with Article 115; and
(e)     the necessary information needed to
demonstrate that the kept terrestrial animals comply with the relevant animal
health requirements for movements provided for in Sections 1 to 6.
2.           The animal health certificate may
include other information required under other Union legislation.
Article 143
Delegation of powers and implementing acts concerning the contents of animal
health certificates 
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     detailed rules on the content of
animal health certificates provided for in Article 142(1) for different
categories and species of kept terrestrial animals and for specific types of
movements provided for in the rules adopted pursuant to Article 144; 
(b)     additional information to be contained
in the animal health certificate provided for in Article 142(1). 
2.           The Commission may, by means of
implementing acts, lay down rules for model forms of animal health
certificates. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 255(2). 
Article 144
Delegation of powers concerning specific types of movements of kept terrestrial
animals 
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning specific measures
supplementing the obligation of operators to ensure that animals are
accompanied by an animal health certificate provided for in Article 140 and the
rules adopted pursuant to Article 141 for the following types of movements of
kept terrestrial animals:
(a)          movements of kept ungulates and
poultry passing through the assembly operations provided for in Article 130
prior to reaching their final place of destination;
(b)          movements of kept terrestrial animals,
which may not continue their route to their final place of destination and are
required to return to their place of origin or to be moved to a different
destination, for one or more of the following reasons:
(i)      their intended route was unexpectedly
interrupted for animal welfare reasons; 
(ii)     unpredicted accidents or events en
route; 
(iii)     the kept terrestrial animals were
rejected at the place of destination in a Member State or at the external
border of the Union;
(iv)    the kept terrestrial animals were
rejected at a place of assembly or resting; 
(v)     the kept terrestrial animals were
rejected in a third country; 
(c)          movements of kept terrestrial
animals intended for exhibitions and sporting, cultural and similar events, and
their subsequent return to their place of origin. 
Article 145
Operators obligations to cooperate with the competent authority for animal
health certification 
Operators shall: 
(a)          provide the competent authority
with all the information necessary to complete the animal health certificate
provided for in Article 140(1) and (2) and rules adopted pursuant to Article 143(1)
or Article 144; 
(b)          where necessary, subject the kept
terrestrial animals to documentary, identity and physical checks as provided
for in Article 146(3).
Article 146
Competent authority responsibility for animal health certification 
1.           The competent authority shall,
upon request by the operator issue an animal health certificate for the
movement of kept terrestrial animals to another Member State, where required by
Article 140 or by delegated acts adopted pursuant to Articles 141(1) and 143(2)
provided that the following movement requirements have been complied with: 
(a)     those provided for in Article 121, Article
122(1), Articles 123, 125, 126, 127, 129, 130 and131, Articles 133(1) and 134(1),
Article 135 and Article 136;
(b)     those provided for in delegated acts
adopted pursuant to Articles 122(2) and 128(1), Article 132, and Articles 133(2),
134(2), 135(4) and 136(4) and Article 137;
(c)     those provided for in implementing acts
adopted pursuant to Article 138. 
2.           Animal health certificates shall:
(a)     be verified and signed by the official
veterinarian;
(b)     remain valid for the period of time,
provided for in the rules adopted pursuant to paragraph 4(c), during which the
kept terrestrial animals covered by it, continue to comply with the animal
health guarantees contained in it. 
3.           The official veterinarian shall,
before signing an animal health certificate, verify that the kept terrestrial
animals covered by it comply with the requirements of this Chapter by means of
documentary, identity and physical checks as provided for by delegated acts
adopted pursuant to paragraph 4.
4.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 laying down rules for: 
(a)     the types of documentary, identity and
physical checks for different species and categories of kept terrestrial
animals that must be carried out by the official veterinarian in accordance
with paragraph 3 of this Article to verify compliance with the requirements of
this Chapter;
(b)     the timeframes for the carrying out of
such documentary, identity and physical checks and the issuing of animal health
certificates by the official veterinarian prior to the movement of consignments
of kept terrestrial animals;
(c)     the duration of the validity of animal
health certificates.
Article 147
Electronic animal health certificates
Electronic animal health certificates, produced,
handled and transmitted by means of IMSOC, may replace accompanying animal
health certificates provided for in Article 146(1) where: 
(a)          such electronic animal health
certificates contain all the information that the model form of animal health
certificate is required to contain in accordance with Article 142 and rules
adopted pursuant to Article 143; 
(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 to their place of
destination in another Member State and ensure that it accompanies such
animals, where they are not required to be accompanied by an animal health
certificate provided for in Article 140(1) and (2). 
2.           The self-declaration document provided
for in paragraph 1 shall contain the following information concerning the kept
terrestrial animals:
(a)     their place of origin, their place of
destination and when relevant any places of assembly or rest; 
(b)     a description of the kept terrestrial
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
rules adopted pursuant to Articles 114 and 117;
(d)     information needed to demonstrate that
the kept terrestrial animals comply with the animal health requirements for movements
provided for in Sections 1 to 6.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     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
self-declaration document in addition to that provided for in paragraph 2 of
this Article. 
4.           The Commission may, by means of
implementing acts, lay down rules for the model forms of the self-declaration
documents provided for in paragraph 2 of this Article. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in
Article 255(2). 
Section 8
Notification of movements of kept terrestrial animals to other Member States 
Article 149
Obligation of operators concerning the notification of movements of kept
terrestrial animals to other Member States
Operators shall notify the competent
authority in their Member State of origin in advance of intended movements of
kept terrestrial animals from that Member State to another Member State where:
(a)          the animals must be accompanied
by an animal health certificate issued by the competent authority of the Member
State of origin in accordance with Articles 146 and 147 and rules adopted
pursuant to Article 146(4);
(b)          the animals must be accompanied
by an animal health certificate for kept terrestrial animals where they are
being moved from a restricted zone and are subject to disease control measures as
referred to in Article 140(2);
(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 accordance with Article 150(1).
Article 150
Competent authority responsibility for notification of movements to other
Member States
1.           The competent authority of the
Member State of origin shall notify the competent authority of the Member State
of destination of movements of kept terrestrial animals as referred to in Article
149.
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 operator to notify partially or completely movements of kept
terrestrial animals through IMSOC to the competent authority of the Member
State of destination.
Article 151
Delegation of power and implementing acts for the notification of movements by operators
and the competent authority
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning: 
(a)     the requirement for advance notification
by operators of movement of kept terrestrial animals between Member States in
accordance with Article 149 of categories or species of animals other than
those referred to in points (a) and (b) of that Article, where traceability of such
movements of those species or categories is necessary to ensure compliance with
the animal health requirements for movements laid down in Sections 1 to 6; 
(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 notification
of movements of kept terrestrial animals in the case of power cuts and other
disturbances of IMSOC;
(d)     the requirements for the designation
of regions by Member States for the management of notification of movements provided
for in Article 150(3).
2.           The Commission may, by means of
implementing acts lay down rules concerning: 
(a)     the format of notifications of
movements of kept terrestrial animals by: 
(i)      operators to the competent authority
of their Member State of origin in accordance with Article 149;
(ii)      the competent authority of the
Member State of origin to the Member State of destination in accordance with Article
150;
(b)     the deadlines for: 
(i)      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 Member
State of origin referred to in Article 150(1).
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Chapter 4
Movements within the Union of terrestrial pet animals
Article 152
Non-commercial movements of terrestrial pet animals and delegated and
implementing acts
1.           Pet keepers shall only carry out
non-commercial movements of terrestrial pet animals of the species listed in
Annex I from one Member State to another Member State where:
(a)     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 and disease control
measures have been taken during that movement, to ensure that the terrestrial pet
animals do not pose a significant risk for the spread of listed diseases referred
to in Article 8(1)(d) and emerging diseases to kept terrestrial animals at
the place of destination and during transport.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the prevention
and disease control measures referred to in paragraph 1(b) of this Article to
ensure that the terrestrial pet animals do not pose a significant risk for the
spread of diseases referred to in Article 8(1)(d) and emerging diseases to
animals during transport and at the place of destination and when relevant
taking into account the health status of the place of destination.
3.           The Commission may, by means of
implementing acts lay down rules concerning the prevention and disease control
measures provided for in paragraph 1 of this Article and the rules adopted
pursuant to paragraph 2 thereof.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 254(2). 
Chapter 5
Movement of wild terrestrial animals
Article 153
Wild terrestrial animals
1.           Operators shall only move wild
animals from a habitat in one Member State to a habitat or to an establishment
in another Member State where: 
(a)     the movements of the wild animals from
their habitat are carried out in such a way that they do not pose a significant
risk for the spread of listed diseases referred to in Article 8(1)(d) or
emerging diseases en route or at the place of destination;
(b)     the wild animals do not come from a
habitat in a restricted zone subject to movement restrictions due to the
occurrence of a listed disease referred to in Article 8(1)(d) or an emerging
disease for the listed species provided for in Article 70(2)(c), Article 80(1)
and (2) and rules adopted pursuant to Articles 70(3)(b) and Articles71(3),
80(4) and Article 81(3) or the emergency measures provided for in Articles 245
and 246 and rules adopted pursuant to Article 248 unless derogations have been
granted in accordance to those rules; 
(c)     the wild animals are accompanied by an
animal health certificate or other documents where animal health certification
is necessary to ensure compliance with the animal health requirements for movements
provided for in points (a) and (b) of this paragraph and the rules adopted
pursuant to Article 154(1)(c) and (d) are complied with; 
(d)     the movement is notified by the
competent authority of the Member State of origin to the competent authority of
the Member State of destination, when animal health certificate is required by
the rules adopted pursuant to Article 154(1)(c) .
2.           When animal health certification
is required by the rules adopted pursuant to Article 154(1)(c) the requirements
provided for in Articles 142 and 145, Article 146(1),(2) and (3), Article 147
and the rules adopted pursuant to Articles 143 and 144 and Article 146(4),
shall apply to movements of wild terrestrial animals.
3.           When notification of movements is
required in accordance with paragraph 1(d) of this Article, the requirements
provided for in Articles 149, 150 and the rules adopted pursuant to delegated
acts laid down in Article 151 shall apply to movements of wild terrestrial
animals.
Article 154
Empowerments concerning the movement of wild terrestrial animals
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     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 the
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
requirements 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 State of destination in the case of movements of wild terrestrial
animals between Member States and the information to be included in such
notification.
2.           The Commission may, by means of
implementing acts, lay down rules specifying the requirements provided for in
Article 153 and the delegated rules adopted pursuant to paragraph 1 concerning:

(a)     model forms of animal health
certificates and other documents which are required to accompany movements of the
wild terrestrial animals, when provided for in delegated acts adopted pursuant
to paragraph 1(c);
(b)     the format of the notification by the
competent authority of the Member State of origin and the deadlines for such
notifications, when provided for in rules adopted pursuant to paragraph 1(d).
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Chapter 6
Movements within the Union of germinal products 
Section 1
General requirements
Article 155
General requirements for movement of germinal products 
1.           Operators shall take appropriate
preventive measures to ensure that the movement of germinal products does not jeopardise
the health status of kept terrestrial animals at the place of destination with
regard to:
(a)     the listed diseases referred to in
Article 8(1)(d);
(b)     emerging diseases.
2.           Operators shall only move germinal
products from their establishments, and receive such germinal products if they
comply with the following conditions: 
(a)     they come from establishments that
have been:
(i)      entered in the register of
establishments by the competent authority in accordance with Article 88(a) and
no derogation has been granted by the Member State of origin in accordance with
Article 83;
(ii)      approved by the competent authority
in accordance with Article 92(1), when required by Article 89(1) or Article 90;
(b)     they comply with the traceability requirements
of Article 118(1) and rules adopted pursuant to Article 119(1).
3.           Operators shall comply with the
requirements of Article 122 for the transport of germinal products of kept
terrestrial animals.
4.           Operators shall not move germinal
products from an establishment in one Member State to an establishment in another
Member State, unless the competent authority of the Member State of destination
gives its express authorisation for such movement, where those germinal
products are required to be destroyed for disease eradication purposes as a
part of an eradication programme provided for in Article 30(1) or (2).
Article 156 
Obligations for operators at the place of destination
1.           Operators
of establishments at the place of destination receiving germinal products from
an establishment in another Member State shall: 
(a)     check for
the presence of:
(i)      identification marks in accordance
with Article 118 and rules adopted pursuant to Article 119; 
(ii)      animal health certificates as
provided for in Article 159; 
(b)     inform the competent authority of any
irregularity with regard to: 
(i)      the germinal products received;
(ii)      the presence of the means of
identification referred to in point (a)(i);
(iii)     the presence of animal health
certificates referred to in point (a)(ii).
2.           In the event of an irregularity
as referred to in paragraph 1(b), the operator shall keep the germinal products
under its supervision until the competent authority has taken a decision
regarding them.
Section 2
Movements to other Member States of germinal products of kept animals of the
bovine, ovine, caprine, porcine and equine species and of poultry 
Article 157
Operators obligations for movements of germinal products of kept animals of the
bovine, ovine, caprine, porcine and equine species and of poultry to other
Member States
1.           Operators shall only move germinal
products of kept animals of the bovine, ovine, caprine, porcine and equine
species and of poultry to another Member State if those germinal products
comply with the following conditions: 
(a)     they are collected, produced, processed
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 the
donor animals which comply with the necessary animal health requirements to
ensure that the germinal products do not spread listed diseases; 
(d)     they have been collected, produced,
processed, stored and transported in a manner to ensure that they do not spread
listed diseases. 
2.           Operators shall not move germinal
products of kept animals of the bovine, ovine, caprine, porcine and equine
species and of poultry from a germinal product establishment which is subject
to movement restrictions affecting the listed species in accordance with: 
(a)     Article 55(1)(a), (c), (e) and Article
55(1)(f)(ii), Article 56 and Article 61(1)(a), Article 62(1), Article 65(1)(c)
and Articles 74(1), 78(1) and (2);
(b)     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 animals of the bovine,
porcine, ovine, caprine and equine species and of poultry to other Member
States
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning the animal health
requirements for movements of germinal products of kept animals of the bovine,
ovine, caprine, porcine and equine species and of poultry to other Member
States provided for in Article 157, specifying:
(a)          rules for the collection,
production, processing and storage of germinal products of those kept animals
in approved establishments as referred to in Article 157(1)(a); 
(b)          animal health requirements
provided for in Article 157(1)(c): 
(i)      for kept animals from which germinal
products were collected; 
(ii)     isolation or quarantine for the kept donor
animals referred to in (i);
(c)          laboratory and other tests on kept
donor animals and germinal products; 
(d)          animal health requirements for
the collection, production, processing, storage or other procedures and
transport provided for in Article 157(1)(d);
(e)          derogations for operators from
the rules provided for in Article 157, taking into account the risks of such
germinal products and any risk mitigating measures in place.
Section 3
Animal health certification and notification of movements
Article 159
Operators' obligations concerning animal health certification for movements of
germinal products of kept animals of the bovine, ovine, caprine, porcine and
equine species and of poultry and delegated acts 
1.           Operators
shall only move germinal products of kept animals of the bovine, ovine,
caprine, porcine and equine species and of poultry where they are accompanied
by an animal health certificate issued by the competent authority of the Member
State of origin in accordance with paragraph 3 when they are moved:
(a)     to another Member State;
(b)     within a Member State or to another
Member State, where:
(i)      the germinal products of kept animals
are allowed to leave a restricted zone subject to disease control measures
provided for in Article 55(1)(f)(ii) and Articles 56, 64 and 65, Article 74(1) and
Artilce78 and rules adopted pursuant to Article 55(2), Article 67, Articles 71(3)
and74(3), Article 79 and Article 81(2) or the emergency measures provided for
in Articles 246 and 247 and the rules adopted pursuant to Article 248 unless
derogations have been granted from the animal health certification requirement
in accordance with the rules referred in this point; and
(ii)      the germinal products of kept
animals are of species subject to those disease control or emergency measures
referred in point (i).
2.           Operators shall take all
necessary measures to ensure that the animal health certificate referred to in
paragraph 1 accompanies the germinal products from their place of origin to
their place of destination.
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 animal health certification of the germinal products
referred to in paragraph 1 of this Article, and Article 148(1) and the rules
adopted pursuant to Article 148(2) shall apply to the for self-declaration of
movements of germinal products. 
5.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning derogations
from the animal health certificate requirements provided for in paragraph 1 of
this Article for the movements of germinal products of kept animals of the
bovine, ovine, caprine, porcine and equine species and of poultry, which do not
pose a significant risk for the spread of listed diseases due to the following:
(a)     the nature of the germinal products or
the species of animal that those products come from; 
(b)     the methods of production and
processing 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 germinal
product establishment.
Article 160
Content of animal health certificates 
1.           The animal health certificate for
the germinal products provided for in Article 159 shall contain at least the
following information: 
(a)     the germinal product establishment of
origin and the establishment or place of destination;
(b)     the type of the germinal products and
the species of kept donor animals; 
(c)     the volume of the germinal products;
(d)     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 demonstrate that
the germinal products of the consignment comply with the movement requirements
for the relevant species provided for in Articles 155 and 157 and rules adopted
pursuant to Article 158.
2.           The animal health certificate for
the germinal products provided for in Article 159 may include other information
required under other Union legislation. 
3.           The Commission shall be empowered
to adopt 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 different
types of germinal products and of different animal species. 
4.           The Commission may, by means of
implementing acts, lay down rules concerning model forms of animal health
certificates for germinal products. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Article 161
Notification of movements of germinal products of kept animals of the bovine,
ovine, caprine, porcine and equine species and of poultry to other Member
States
1.           Operators
shall: 
(a)     inform
the competent authority in their Member State of origin in advance of the
intended movement of germinal products of kept animals of the bovine, ovine,
caprine, porcine and equine species and of poultry to another Member State
when: 
(i)      the germinal products are required to
be accompanied by an animal health certificate in accordance with Article 159(1);
(ii)      notification of movement is required
in accordance with delegated acts adopted pursuant to Article 151(1) for
germinal products, taking into account paragraph 3 of this Article;
(b)     provide all the necessary information
to enable the competent authority of the Member State of origin to notify the
movement of the germinal products to the competent authority of the Member
State of destination in accordance with paragraph 2.
2.           The competent authority of the
Member State of origin shall notify the competent authority of the Member State
of destination of movements of germinal products of kept animals of the bovine,
ovine, caprine, porcine and equine species and of poultry in accordance with
the rules adopted pursuant to Article 151.
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 terrestrial 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, caprine, porcine and equine species and of
poultry to another Member State if they do not pose a significant risk for the
spread of listed diseases referred to in Article 8(1)(d) to listed species
at the place of destination, taking into account the health status at the place
of destination. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning animal health
requirements, animal health certification and notification requirements for
movements of germinal products of kept terrestrial animals of species other
than those of the bovine, ovine, caprine, porcine and equine species and of
poultry taking into account the following matters:
(a)     listed diseases referred to in Article
8(1)(d) for the listed species; 
(b)     the species of animals from which the germinal
product have been collected and type of germinal product; 
(c)     the health status at the places of
origin and of destination;
(d)     the type of collection, production, processing
and storage;
(e)     other epidemiological factors.
3.           Where animal health certification
and the notification of movements of the germinal products are required in
accordance with paragraph 2 of this Article: 
(a)     the rules provided for in Articles 159,
160 and Article 161 and the rules adopted pursuant to Articles 159(5) and 160(3)
shall apply for such certification; 
(b)     the rules provided for in Article 161(1)
and (2) shall apply for movement notification.
Section 5
Derogations
Article 163
Germinal products intended for scientific purposes and delegated acts
1.           By way of derogation from
Sections 1 to 4, the competent authority of the place of destination may
authorise movements of germinal products for scientific purposes, which do not
comply with the requirements of those Sections, with the exception of Article
155(1), Article 155(2)(c), Article 155(3) and Article156, subject to compliance
with the following conditions:
(a)     prior to granting such authorisation
the competent authority of the place of destination must take the necessary risk
mitigating measures to ensure that the movements of those germinal products do
not jeopardise the health status en route and of the places of destination with
regard to the listed diseases referred to in Article 8(1)(d);
(b)     the movements of those germinal
products take place under the supervision of the competent authority of the
place of destination.
2.           When granting a derogation in accordance with paragraph
1, the competent authority of the place of destination shall notify the Member
States of origin and the Member States of passage of the derogation granted and
the conditions under which it has been granted. 
3.           The Commission shall be empowered to adopt delegated
acts in accordance with Article 253 concerning conditions for derogations by
the competent authority of the place of destination, as provided for in
paragraph 1 of this Article. 
Chapter 7
Production, processing and distribution within the Union of products of
animal origin 
Article 164
General animal health obligations for operators and delegated acts
1.           Operators shall take appropriate
preventive measures to ensure that at all stages of the production, processing
and distribution of products of animal origin in the Union, such products do
not cause the spread of:
(a)     listed diseases referred to in Article
8(1)(d) taking into account the health status of the place of production,
processing or destination;
(b)     emerging diseases.
2.           Operators shall ensure that
products of animal origin do not come from establishments or food business
establishments or are obtained from animals which come from establishments
subject to:
(a)     emergency measures provided for in
Articles 246 and 247 and rules adopted pursuant to Article 248 unless
derogations from the requirement provided for in paragraph 1 are provided for
in rules adopted pursuant to Article 248;
(b)     movement restrictions applicable to kept
terrestrial animals and products of animal origin, as provided for in Articles
31(1), Article 55(1)(e), Article 56, Article 61(1)(a), Article 62(1),
Article 65(1)(c), Article 70(1)(b), Article 74(1)(a), Article 78(1) and (2) and
the rules adopted pursuant to Articles 55(2), Articles 63 and 66, Article 71(3),
Article 74(3) and Articles 79 and Article 81(2) unless derogations from those
movement restrictions are provided for in those rules.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed
requirements amending and supplementing the requirements of paragraph 2 of
this Article for the movement of products of animal origin, taking into account:

(a)     the listed disease referred to in
Article 8(1)(d) and species concerned by it and 
(b)     the risks involved.
Article 165
Animal health certificates obligations on operators and delegated acts
1.           Operators shall only move the
following products of animal origin within a Member State or to another Member
State where they are accompanied by an animal health certificate issued by the
competent authority of the Member State of origin in accordance with paragraph
3: 
(a)     products of animal origin that: 
(i)      are allowed to be moved from a
restricted zone subject to emergency measures provided for in rules adopted
pursuant to Article 248; 
(ii)      originate from animals of species
subject to those emergency measures; 
(b)     products of animal origin that:
(i)      are allowed to be moved from
restricted zone subject to disease control measures in accordance with Article
31(1), Article 55(1)(f)(ii), Article 56, Article 61(1)(a), Article 62(1), Article
64, Articles 65(1)(c), 70(1)(b) and 74(1)(a) and Article78(1) and (2) and rules
adopted pursuant to Articles 55(2), Articles 63 and 67, Article 71(3) and74(3),
Article 79 and Article 81(2), 
(ii)      originate from animals of species
subject to those disease control measures.
2.           Operators shall take all
necessary measures to ensure that the animal health certificate referred to in
paragraph 1 accompanies the products of animal origin from their place of
origin to their place of destination.
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 adopted pursuant to Articles 143 and144 and Article 146(4) shall apply to
the animal health certification of the movements of the products of animal
origin referred to in paragraph 1 of this Article. 
5.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning derogations
from the animal health certificate requirements provided for in paragraph 1 of
this Article and the conditions for such derogations, for movements of products
of animal origin which do not pose a significant risk for the spread of
diseases due to: 
(a)     the types of products of animal
origin;
(b)     the risk mitigating measures applied to
the products of animal origin, thereby reducing the risks of the spread of
diseases; 
(c)     the intended use of the products of
animal origin; 
(d)     the place of destination of the
products of animal origin. 
Article 166
Content of animal health certificates and delegated and implementing acts
1.           The animal health certificate for
products of animal origin provided for in Article 165(1) shall contain at least
the following information: 
(a)     the establishment or place of origin
and the establishment or place of destination;
(b)     a description of the products of
animal origin; 
(c)     the quantity of the products of animal
origin;
(d)     the identification of the products of
animal origin, when required by Article 65 (1)(h) or rules adopted pursuant to
Article 67(a);
(e)     information needed to demonstrate that
the products of animal origin comply with the movement restriction requirements
provided for in Article 164(2) and rules adopted pursuant to Article 164(3).
2.           The animal health certificate for
products of animal origin referred to in paragraph 1 may include other
information required under other Union legislation. 
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the
information to be contained in the animal health certificate as provided for in
paragraph 1 of this Article.
4.           The Commission may, by means of
implementing acts, lay down rules concerning model forms of animal health
certificates for products of animal origin referred to in paragraph 1 of this
Article. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 255(2). 
Article 167
Notification of movements of products of animal origin to other Member States
1.           Operators shall:
(a)     inform the competent authority in
their Member State of origin in advance of the intended movement of the products
of animal origin when the consignments are required to be accompanied 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 destination in
accordance with paragraph 2.
2.           The competent authority of the
Member State of origin shall notify the competent authority of the Member State
of destination of movements of products of animal origin in accordance with
Article 150 and the rules adopted pursuant to Article 151.
3.           Articles 149 and 150 and rules
adopted pursuant to Article 151 shall be applicable to the notification of
products of animal origin.
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 products 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
appropriate and necessary to prevent the introduction and spread of the listed diseases
referred to in Article 8(1)(d).
Article 169
National measures for limiting the impact of diseases other than listed
diseases
Where a disease other than listed diseases
constitutes a significant risk for the animal health situation of kept terrestrial
animals in a Member State, the Member State concerned may take national measures
to control that disease, provided those measures do not:
(a)          hinder the movement of animals
and products between Member States; 
(b)          exceed the limits of what is
appropriate and necessary to control that disease.
TITLE II 
Aquatic animals and products of animal origin from aquatic animals
Chapter 1
Registration, approval, record keeping and registers
Section 1
Registration of aquaculture establishments
Article 170 
Obligation of operators to register aquaculture establishments 
1.            Operators of aquaculture establishments shall, in order to be
registered in accordance with Article 171, before they commence such activities:

(a)     inform the competent authority of any
aquaculture establishment under their responsibility;
(b)     provide the competent authority with
information on:
(i)      the name and address of the operator;
(ii)      the location and a description of
the facilities;
(iii)     the categories, species and numbers
of aquaculture animals on the aquaculture establishment and the capacity of the
aquaculture establishment;
(iv)     the type of aquaculture establishment;
(v)     other aspects of the establishment
which are relevant in determining the risk posed by it. 
2.           Operators of aquaculture establishments
referred to in paragraph 1 shall inform the competent authority of any:
(a)     significant changes in the aquaculture
establishments concerning the matters referred to in paragraph 1(b);
(b)     cessation of activity in the aquaculture
establishment.
3.           Aquaculture establishments which
are subject to approval in accordance with Article 174(1) shall not be required
to provide the information referred to in paragraph 1 of this Article.
4.           An operator may apply for a
registration provided for in paragraph 1 to cover a group of aquaculture
establishments provided that they comply with the conditions laid down in either
points (a) or (b):
(a)     they are located in an
epidemiologically linked area and all operators in that area operate under a
common biosecurity system; 
(b)     they are under the responsibility of
the same operator, and
(i)      under a common biosecurity system;
and
(ii)      located in geographical proximity.
Where an application for registration covers a
group of establishments, the rules laid down in paragraphs 1 to 3 of this
Article and Article 171(2) and the rules adopted pursuant to Article 173, which
are applicable to a single aquaculture establishment shall be applicable to the
whole group of aquaculture establishments.
Article 171 
Obligations of the competent authority concerning the registration of aquaculture
establishments
The competent authority shall register: 
(a)          aquaculture establishments in the register of
aquaculture establishments provided for in Article 183(1), where the operator
has provided the information required in accordance with Article 170(1);
(b)          groups of aquaculture establishment in that register of
aquaculture establishments provided that the criteria laid down in Article
170(4) are complied with.
Article 172
Derogations from the obligation of operators to register aquaculture establishments

By way of derogation from Article 170(1),
Member States may exempt certain categories of aquaculture establishments from
the registration requirement taking into account the following criteria:
(a)          the categories, species and
number or volume of aquaculture animals on the aquaculture establishment and
the capacity 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 obligation to register aquaculture
establishments
The Commission may, by means of
implementing acts lay down rules concerning:
(a)          the information to be provided by
operators for the purpose of the 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
Member States as provided for in Article 172, provided that they pose an
insignificant risk and taking into account the criteria provided for Article
172.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Section 2
Approval of certain types of aquaculture establishments 
Article 174
Approval of certain aquaculture establishments and delegated acts
1.           Operators of the following types
of aquaculture establishments shall apply to the competent authority for
approval in accordance with Article 178(1) and they shall not commence their
activities until their aquaculture establishment has been approved in
accordance with Article 179(1): 
(a)     aquaculture establishments where
aquaculture animals are kept with the view to their being moved from that
aquaculture establishment either alive or as products of aquaculture animal
origin, however, such application shall not be required where they are solely
moved either for: 
(i)      for a direct supply for human
consumption of small quantities to the final consumer; or 
(ii)      to local retail establishments
directly supplying the final consumer.
(b)     other aquaculture establishments which
pose a high risk due to:
(i)      the categories, species and number of
aquaculture animals on the aquaculture establishment; 
(ii)      the type of aquaculture
establishment;
(iii)     movements of aquaculture animals
into and out of the aquaculture establishment.
2.           Operators shall cease activity at
an aquaculture establishment referred to in paragraph 1 where:
(a)     the competent authority withdraws or
suspends its approval in accordance with Article 182(2); or 
(b)     in the event of conditional approval, granted
in accordance with Article 181(3), the aquaculture establishment fails to
comply with the outstanding requirements referred to in Article 181(3) and does
not obtain a final approval in accordance with Article 182(4). 
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning supplementing
and amending the rules for the approval of aquaculture establishments provided
for in paragraph 1 of this Article concerning:
(a)     derogations from the requirement for
operators to apply to the competent authority for approval of the types of
aquaculture establishments referred to in paragraph 1(a); 
(b)     the types of aquaculture establishments
that must be approved in accordance with paragraph 1(b).
4.           The Commission shall take the
following criteria into account, when adopting delegated acts provided for in
paragraph 3:
(a)     the species and categories of
aquaculture animals kept in an aquaculture establishment;
(b)     the type of aquaculture establishment
and the type of production;
(c)     typical movement patterns of the type
of aquaculture establishment and concerned species or category of aquaculture animals.
5.           An operator may apply for an approval
of group of aquaculture establishments provided that the requirements provided
for in Article 175(a) and (b) are complied with.
Article 175
Approval by the competent authority of group of aquaculture establishments 
The competent authority may grant approval as
provided for in Article 179(1) covering a group of aquaculture establishments,
provided that they comply with the conditions laid down in either point (a) or
point (b):
(a)          they are located in an
epidemiologically linked area and all operators operate under a common
biosecurity system; however, dispatch centres, purification centres and similar
establishments located inside such an epidemiologically linked area must be
approved individually; 
(b)          they are under the responsibility
of the same operator; and
(i)      under a common biosecurity system;
and
(ii)     located in geographical proximity.
When a single approval is granted for a
group of aquaculture establishments, the rules laid down in Article 176
and Articles 178 to 182 and the rules adopted pursuant to Articles 178(2) and
179(2) which are applicable to a single aquaculture establishment shall be
applicable to the group of aquaculture establishments.
Article 176
Approval of status of confined aquaculture establishments
Operators of aquaculture establishments,
who 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) and any delegated acts adopted in accordance with Article
203(2) until their establishment obtains an approval of that status by the
competent authority in accordance with Article 179 or Article 181. 
Article 177
Approval of disease control aquatic food establishments
Operators of disease control aquatic food
establishments shall ensure that their establishments are approved by the
competent authority to slaughter aquatic animals for disease control purposes
in accordance with Article 61(1)(b), Article 62 and Articles 68(1), 78(1) and
(2) and the rules adopted pursuant to Article 63 and Articles 70(3), 71(3) and
78(3).
Article 178
Information obligation of operators in view to obtain approval and implementing
acts
1.           Operators shall, for the purposes
of their application for the approval of their establishment provided for in
Article 174(1), Article 175, Article 176(a) and Article 177 provide the
competent authority with the information on:
(a)     the name and address of the operator;
(b)     the location of the establishment and a
description of facilities;
(c)     the categories, species and numbers of
aquaculture animals on the establishment;
(d)     the type of establishment;
(e)     where relevant, the details of the
approval of a group of aquaculture establishments in accordance with Article
175;
(f)      other aspects of the aquaculture
establishment, which are relevant in determining the risk posed by it. 
2.           Operators of establishments
referred to in paragraph 1 shall inform the competent authority of any:
(a)     significant changes in the
establishments concerning the matters referred to in paragraph 1(c);
(b)     cessation of activity in the
establishment.
3.           The Commission may, by means of implementing
acts, lay down rules concerning the information to be provided by operators in
the application for the approval of their establishment, in accordance with
paragraph 1 of this Article. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Article 179
Granting of approval and conditions for approval and delegated acts
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 control 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 biosecurity
measures taking into account the requirements provided for in Article 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 pursuant to Article 24; 
(iii)     record keeping provided for in
Articles 185 to 187 and the rules adopted pursuant to Articles 188 and 189;
(b)     have facilities and equipment that are:
(i)      adequate to reduce the risk of the
introduction and spread of diseases to an acceptable level, taking into account
the type of establishment;
(ii)      of adequate capacity for the
quantity of aquatic animals;
(c)     do not lead to an unacceptable risk
for the spread of disease, taking into account the risk mitigating measures in
place; 
(d)     have a system in place which enables
the operator to demonstrate to the competent authority that the requirements laid
down in points (a), (b) and (c) are fulfilled. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the requirements
provided for in paragraph 1 of this Article as regards:
(a)     quarantine, isolation and other
biosecurity measures referred to in paragraph 1(a)(i); 
(b)     surveillance referred to in paragraph
1(a)(ii);
(c)     facilities and equipment referred to
in paragraph 1(b). 
3.           The Commission shall take into
account the following matters when establishing the rules to be laid down in
the delegated acts to be adopted pursuant to paragraph 2:
(a)     the risks posed by each type of
establishment;
(b)     the species and categories of aquaculture
or aquatic animals;
(c)     the type of production;
(d)     typical movement patterns of the type
of aquaculture establishment and species and categories of animals kept in
those establishments.
Article 180
Scope of the approval of establishments 
The competent authority shall expressly specify
in approvals of aquaculture establishment or a disease control aquatic food
establishment granted pursuant to Article 179(1):
(a)          for which of the types of aquaculture establishments
referred to in Article 174(1), Article 176(a), groups of aquaculture
establishments referred to in Article 175 and disease control aquatic food
establishments referred to in Article 177, and rules adopted pursuant to
Article 174(3)(b) the approval applies;
(b)          for which species and categories of aquaculture animals
the approval applies.
Article 181
Procedures for granting the approval by the competent authority 
1.           The competent authority shall
establish procedures for operators to follow when applying for approval of
their establishments in accordance with Article 174(1) and Articles 176 and 177.
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
conditional approval of an establishment where it appears, based on the
application of the operator and the subsequent on-site visit of the establishment
by the competent authority as provided for in paragraph 1 of this Article, that
it meets all the main requirements that provide sufficient guarantees that such
an establishment does not represent a significant risk, with a view to ensuring
the compliance with the outstanding requirements for approval provided for in
Article 179(1) and the rules adopted pursuant to Article 179(2). 
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 granting conditional approval, that the establishment meets all the requirements
for approval provided for in Article 179(1) and the rules adopted pursuant to
Article 179(2). 
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 approvals by the competent authority 
1.           The competent authority shall
keep the approvals of establishments granted in accordance with Article 179(1)
under review.
2.           Where the competent authority
identifies serious deficiencies in the establishment as regards compliance with
the requirements laid down in Article 179(1) and the rules adopted pursuant to
Article 179(2) and the operator is not able to provide adequate guarantees that
those deficiencies will be resolved, the competent authority shall initiate
procedures to withdraw the establishment's approval. 
However, the competent authority may suspend an
establishment's approval where the operator can guarantee that it will resolve
deficiencies within a reasonable period of time.
3.           Approval shall only be restored after withdrawal or
suspension in accordance with paragraph 2 when the competent authority is
satisfied that the establishment fully complies with all the requirements of
this Regulation, appropriate for that type of establishment.
Section 3
Register of the competent authority of aquaculture establishments and disease
control aquatic food establishments
Article 183
Register of aquaculture establishments and disease control aquatic food
establishments
1.           The competent authority shall
establish and keep up–to-date a register of: 
(a)     all aquaculture establishments
registered in accordance with Article 171;
(b)     all aquaculture establishments
approved in accordance with Articles 179(1); 
(c)     all disease control aquatic food
establishments approved in accordance with Article 179(1).
2.           The register of aquaculture establishments
provided for in paragraph 1 shall contain information on:
(a)     the name and address of the operator
and its registration number;
(b)     the geographical position of the
aquaculture establishment or when applicable, the group of aquaculture
establishments;
(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
accordance with Article 179(1), the competent authority shall make publicly
available by electronic means at least the information referred to in paragraph
2(a), (c), (e) and (f) of this Article.
4.           Where appropriate and relevant,
the competent authority may combine the registration provided for in paragraph
1 with registration for other purposes.
Article 184
Delegation of powers and implementing acts concerning the register of aquaculture
establishments
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 254 concerning: 
(a)     the information to be included in the
register of aquaculture establishments provided for in Article 183(1);
(b)     the public availability of that
register of establishments.
2.           The Commission may, by means of
implementing acts, lay down rules on the format of and procedures for the
register of establishments provided for in Article 183(1) and (3).
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Section 4
Record keeping and traceability
Article 185 
Record keeping obligations of operators of aquaculture establishments 
1.           Operators of aquaculture establishments
subject to registration in accordance with Article 171 or approval in
accordance with Article 179(1) shall keep up-to-date records containing at
least the following information:
(a)     all movements of aquaculture animals
and products of animal origin obtained from those animals into and out of the
aquaculture establishment, stating as appropriate:
(i)      their place of origin or destination;

(ii)      the date of such movements;
(b)     the animal health certificates in paper
or electronic form required to accompany movements of aquaculture animals
arriving at the aquaculture establishment in accordance with Article 208 and the
rules adopted pursuant to Articles 211(b) and (c) and Article 213(2);
(c)     the mortality in each epidemiological
unit and other disease problems at the aquaculture establishment as relevant
for the type of production; 
(d)     biosecurity measures, surveillance,
treatments, test results and other relevant information as appropriate for: 
(i)      the category and species of the
aquaculture animals on the establishment;
(ii)      the type of production at the aquaculture
establishment;
(iii)     the type of aquaculture establishment;
(e)     the results of the animal health
visits, when required in accordance with Article 23(1) and the rules adopted
pursuant to Article 24; 
2.           Operators of aquaculture
establishments shall:
(a)     record the information provided for in
paragraph 1(a) in such a way that the tracing of the place of origin and
destination of aquatic animals can be guaranteed; 
(b)     keep the information provided for in
paragraph 1 on the aquaculture establishment and, made it available to the
competent authority on request;
(c)     retain the information provided for in
paragraph 1 for a minimum period to be determined by the competent authority,
but which may not be less than a period of three years.
Article 186
Record keeping obligation for disease control aquatic food establishments
1.           Operators of disease control
aquatic food establishments subject to approval in accordance with Article 177
shall keep up-to-date records of all movement of aquaculture animals and
products of animal origin obtained from such animals into and out of such
establishments.
2.           Operators of disease control
aquatic food establishments shall:
(a)     keep the records provided for in
paragraph 1 on the disease control aquatic food establishment and make them
available to the competent authority on request;
(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 disease
control aquatic food establishments visited by the means of transport; 
(c)     any exchange of water that took place
during transport, specifying the sources of new water and sites of release of
water.
2.           Transporters shall:
(a)     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 adopt delegated acts in accordance with Article 253 concerning rules
supplementing the record keeping requirements provided for in Articles 185, 186
and 187 laying down rules on:
(a)     derogations from the record keeping
requirements for: 
(i)      operators of certain categories of aquaculture
establishments and transporters;
(ii)      aquaculture establishments keeping a
small number of animals or transporters transporting a small number of animals;
(iii)     certain categories or species of
animals;
(b)     information to be recorded by
operators in addition to that provided for in Articles 185(1), 186(1) and 187(1);
(c)     the minimum period of time during
which records provided for in Articles 185, 186 and 187 are required must be
kept.
2.           The Commission shall take the
following matters into account when adopting the delegated acts provided for in
paragraph 1:
(a)     the risks posed by each type of aquaculture
establishment;
(b)     the categories or species of aquaculture
animals on 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 implementing 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 aquatic animals other than aquatic pet animals
Section 1 
General Requirements
Article 190 
General requirements for movement of aquatic animals 
1.           Operators shall take appropriate
measures to ensure that the movement of aquatic animals does not jeopardise the
health status at the place of destination with regard to: 
(a)     the listed diseases referred to in
Article 8(1)(d); 
(b)     emerging diseases.
2.           Operators shall not move aquatic animals into an
aquaculture establishment or for human consumption or release them into the
wild, where such aquatic animals are subject to:
(a)     movement restrictions affecting the
category and species concerned in accordance with the rules laid down in
Article 55(1), Article 56, Article 61(1), Articles 62, 64 and 65, Article 70(1)
and (2), Articles 74(1), 78(1) and (2), 80(1) and (2) and the rules adopted
pursuant to Article 55(2), Articles 63 and 67, Articles 70(3), 71(3 and 74(3),
Article 79, and Articles 80(4) and 81(2); or 
(b)     the emergency measures laid down in
Articles 244 and 247 and the rules adopted pursuant to Article 248.
However, operators may move those aquatic
animals where derogations from the movement restrictions for such movements or
release are provided for in Title II of Part III or derogations from emergency
measures in rules adopted pursuant to Article 248. 
3.           Operators shall take all necessary measures to ensure
that aquatic animals, after leaving their place of origin, are consigned
without delay to the final place of destination.
Article 191
Disease preventive measures in relation to transport and delegated acts
1.           Operators shall take the
appropriate and necessary disease preventive measures to ensure that:
(a)     the health status of aquatic animals
is not jeopardised during transport;
(b)     transport operations of aquatic
animals do not cause the potential spread of listed diseases referred to in
Article 8(1)(d) to humans or animals en route, and at places of destination;
(c)     cleaning, disinfection and
disinfestations of equipment and means of transport and other adequate
biosecurity measures are taken, as appropriate to the risks involved with the
transport;
(d)     any exchanges of water during the transport
of aquatic animals intended for aquaculture are carried out at places and under
conditions which do not jeopardise the health status with regard to the listed
diseases referred to in Article 8(1)(d) of:
(i)      the aquatic animals being
transported;
(ii)      any aquatic animals en-route to the
place of destination; 
(iii)     aquatic animals at the place of
destination.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     the cleaning, disinfection and
disinfestations of equipment and means of transport in accordance with paragraph
1(c) and the use of biocidal products for such purposes;
(b)     other appropriate biosecurity measures
during transport as provided for in paragraph 1(c);
(c)     water exchanges during transport as
provided for in paragraph 1(d).
Article 192
Change of intended use
1.           Aquatic animals which are moved
for destruction or slaughter in accordance with the measures referred to in
point (a) or (b) shall not be used for any other purpose:
(a)     disease control measures provided for
in Articles 31(1) and 55(1), Articles 56, 61, 62, 64, 65, 67 and 70, Article 74(1)
and Articles78 and 80 and the rules adopted pursuant to Article 55(2), Articles
63 and 66, Articles 70(3), 71(3) and 74(3), Article 79, and Articles 80(3) and
81(2);
(b)     emergency measures provided for in
Articles 246 and 247 and rules adopted pursuant to Article 248.
2.           Aquatic animals moved for human
consumption, aquaculture, release into the wild or any other specific purpose,
shall not be used for any purpose other than the intended one. 
Article 193
Obligations for operators at the place of destination
1.           Operators of establishments and
food business establishments receiving aquaculture animals shall: 
(a)     check that one of the following
documents are present:
(i)      the animal health certificates provided
for in Article 208(1), Article 209 and Article224(1) and the rules adopted
pursuant to Articles 188, 211 and 213 are present; 
(ii)      the self-declaration documents provided
for in Article 218(1) and the rules adopted pursuant to Article 218(3) and (4) are
present; 
(b)     inform the competent authority of any
irregularity with regard to:
(i)      the aquaculture animals received;
(ii)      the presence of the documents
referred to in point (a) (i) and (ii).
2.           In the event of any irregularity
as referred to in paragraph 1(b), the operator shall isolate the aquaculture
animals concerned by that irregularity until the competent authority has taken
a decision regarding them.
Article 194
General requirements for movements of aquaculture animals passing through
Member States but intended for export from the Union to third countries or
territories 
Operators shall ensure that aquaculture animals
intended for export to a third country or territory and passing through the
territory of other Member States fulfil the requirements laid down in Articles 190,
191 and 192.
Section 2
Aquatic animals intended for aquaculture establishments or to be released into
the wild 
Article 195 
Abnormal mortalities or other serious disease symptoms
1.           Operators shall not move aquatic
animals from an aquaculture establishment or from the wild to another
aquaculture establishment or release them into the wild if they originate from
an aquaculture establishment or environment where there are: 
(a)     abnormal mortalities; or 
(b)     other serious disease symptoms with an
undetermined cause. 
2.           By way of derogation from
paragraph 1, the competent authority may authorise such movement or release of
aquatic animals, based on an evaluation of risks, provided that the aquatic
animals originate from a part of the aquaculture establishment or from the wild
that is independent of the epidemiological unit where the abnormal mortalities
or other disease symptoms have occurred.
Article 196
Movement of aquaculture animals intended for Member States, zones or
compartments which have been declared disease free or which are subject to an
eradication programme and delegated acts
1.           Operators shall only move aquaculture
animals from an aquaculture establishment for the purposes referred to in point
(a) or (b) of this Article, if those aquaculture animals originate from a
Member State, or zone or compartment thereof, which has been declared disease-free
in accordance with Article 36(3) or 37(4) for listed diseases referred to in
Article 8(1)(b) or (c) when they are of listed species for those listed diseases
and the aquaculture animals are:
(a)     to be introduced into a Member State, or
zone or compartment thereof which is: 
(i)      has been declared disease free in
accordance with Article 36(3) or Article 37(4); or 
(ii)      subject to a eradication programme
as provided for in Article 30(1) and (2) as regards one or more of the listed
diseases referred to in Article 8(1)(b) and (c); 
(b)     intended for:
(i)      an aquaculture establishment subject
to: 
–              
registration in accordance with Article 171: or 
–              
approval in accordance with Articles 174, 175, 176
and Article 177; or
(ii)      release into the wild. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning derogations
from the movement or release requirements of paragraph 1 of this Article, which
do not pose a significant risk for the spread of listed diseases referred to in
Article 8(1)(d due to:
(a)     the species, categories, and life
stage of the aquaculture animals;
(b)     the type of establishment of origin
and of destination;
(c)     the intended use of the aquaculture
animals;
(d)     the place of destination of the
aquaculture animals;
(e)     treatments, processing methods and
other special risk mitigating measures applied at places of origin or
destination.
Article 197
Derogations by Member States concerning the obligation of operators for
movement of aquaculture animals between Member States, zones or compartments
which are subject to an eradication programme
By way of derogation from Article 196(1),
Member States may authorise operators to move aquaculture animals into a zone or
compartment in another Member State for which an eradication programme has been
established in accordance with Article 30(1) and (2) as regards the listed
diseases referred to in Article 8(1)(b) and (c), from another zone or
compartment for which such a programme has also been established for the same listed
diseases, provided that such movement will not jeopardise the health status of
the Member State, zone or compartment of destination.
Article 198
Member States' measures concerning the release of aquaculture animals into the
wild
Member States may require that aquaculture
animals shall only be released into the wild if they originate from a Member
State, or zone or compartment declared disease-free in accordance with Article
36(1) or Article 37(1) as regards the listed diseases referred to in Article 8(1)(b)
and (c) for which the species of aquaculture animals to be moved is a listed
species, regardless of the health status of the area where the aquaculture
animals are to be released. 
Article 199
Movement of wild aquatic animals intended for Member States, zones or
compartments which have been declared disease-free or which are subject to an
eradication programme and delegated acts
1.           Articles 196 and 197 shall also
apply to movements of wild aquatic animals intended for an aquaculture establishment
or disease control aquatic food establishment subject to: 
(a)     registration in accordance with
Article 171; or 
(b)     approval in accordance with Articles
174 to 177. 
2.           Operators shall take disease preventive measures when
moving wild aquatic animals between habitats so that such movements do not pose
a significant risk for the spread of listed diseases referred to in Article 8(1)(d)
to aquatic animals at the place of destination.
3.           The Commission shall be empowered to adopt delegated
acts in accordance with Article 253 concerning the disease preventive measures
to be taken by operators as provided for in paragraph 2 of this Article. 
Section 3
Aquatic animals intended for human consumption 
Article 200 
Movement of aquaculture animals intended for Member States, zones or
compartments which have been declared disease-free or which are subject to an
eradication programme and delegated acts
1.           Operators shall only move aquaculture
animals from an aquaculture establishment for the purposes referred to in point
(a) or (b) of this paragraph, if those aquaculture animals originate from a
Member State, or zone or compartment thereof, which has been declared disease-free
in accordance with Article 36(3) or 37(4) for listed diseases referred to in
Article 8(1)(b) or (c) when they are of listed species for those listed diseases
and they are:
(a)     to be introduced into a Member State,
or zone or compartment thereof which has been declared disease free in
accordance with Articles 36(3) or 37(4) or for which a eradication programme has
been established in accordance with Article 30(1) or (2) as regards one or more
of the listed diseases referred to in Article 8(1)(b) and (c); 
(b)     intended for human consumption.
2.           By way of derogation from
paragraph 1 of this Article Member States may authorise operators to introduce
aquaculture animals into a zone or compartment for which an eradication
programme has been established in accordance with Article 30(1) or (2) as
regards the listed diseases referred to in Article 8(1)(b) and (c), from
another zone or compartment for which such a programme has also been
established as regards the same diseases within that Member State, provided
that such movement will not jeopardise the health status of the Member State, or
zone or compartment thereof.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the derogations
from movement requirements provided for in paragraph 2 of this Article for
those movements of aquaculture animals which do not pose significant risk of
spreading of diseases due to:
(a)     the species, categories, and live
stage of the aquaculture animals;
(b)     the methods of keeping the aquaculture
animals and type of production in the aquaculture establishments of origin and
of destination;
(c)     the intended use of the aquaculture
animals;
(d)     the place of destination of the
aquaculture animals;
(e)     treatments, processing methods and
other special risk mitigating measures applied at place of origin or place of
destination.
Article 201 
Movement of wild aquatic animals intended for Member States, zones or
compartments which have been declared disease-free or which are subject to an
eradication programme and delegated acts
1.           Article 200(1) and (2) and the
rules adopted pursuant to Article 200(3) shall also apply to movements of wild
aquatic animals intended for human consumption and which are intended for
Member States, or zones or compartments thereof, which have been declared
disease-free in accordance with Articles 36(3) or 37(4) or are subject to an
eradication programme in accordance with Article 30(1) or (2), where such
measures are necessary to ensure that those wild aquatic animals do not pose a
significant risk for the spread of listed diseases referred to in Article 8(1)(d)
to aquatic animals at the place of destination.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning movement
requirements for wild aquatic animals intended for human consumption
supplementing paragraph 1 of this Article.
Section 4
Aquatic animals not intended for establishments, release into the wild or for human
consumption
Article 202
Movement of aquatic animals not intended for establishments, release into the
wild or for human consumption and delegated acts
1.           Operators shall take the
necessary preventive measures to ensure that movements of aquatic animals not
intended for establishments, release into the wild or for human consumption do
not pose a significant risk for the spread of listed diseases referred to in
Article 8(1)(d) to aquatic animals at the place of destination.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the
preventive measures provided for in paragraph 1 of this Article to ensure that
the aquatic animals do not spread the listed diseases referred to in Article 8(1)(d),
whilst taking into account the matters referred to in paragraph 3 of this Article.

3.           The Commission shall take the
following 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
diseases referred to in Article 8(1)(d) at the compartments, zones or Member
States of origin and destination; 
(c)     the places of origin and of
destination;
(d)     the type of movements of the aquatic
animals; 
(e)     the species and categories of the aquatic
animals; 
(f)      the age of the aquatic animals;
(g)     other epidemiological factors.
Section 5
Derogations from sections 1 to 4 and Additional risk mitigation measures 
Article 203
Aquatic animals intended for confined aquaculture establishments and delegated
acts 
1.           Operators shall only move aquatic
animals to a confined aquaculture establishment if they comply with the
following conditions:
(a)     they originate from another confined aquaculture
establishment; 
(b)     they do not pose a significant risk
for the spread of listed diseases referred to in Article 8(1)(d) to listed
species of animals at the confined aquaculture establishment of destination
except where such movement is authorised for the scientific purposes. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     detailed requirements for movements 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
aquaculture animals to confined aquaculture establishments where the risk
mitigating measures in place guarantee that such movements do not pose a
significant risk for the health of aquaculture animals within that confined
aquaculture establishment and surrounding establishments.
Article 204
Derogation for movements of aquatic animals for scientific purposes and delegated
acts
1.           The competent authority of the
place of destination may, subject to the agreement of the competent authority
of the place of origin, authorise movements into their territory of aquatic
animals for scientific purposes, which do not comply with the requirements of
Sections 1 to 4, with the exception of Articles 190(1) and (3), and Articles
191, 192 and Article 193.
2.           The competent authorities shall
only grant derogations for movements of aquatic animals for scientific
purposes, as provided for in paragraph 1 under the following conditions:
(a)     the competent authorities of the place
of destination and of the place of origin:
(i)      have agreed on the conditions for
such movements;
(ii)      have taken the necessary risk
mitigating measures to ensure that the movements of those aquatic animals do
not jeopardise the health status en route and of the places of destination with
regard to the listed diseases referred to in Article 8(1)(d); 
(iii)     have notified, where relevant, the
competent authority of Member States of passage of the derogation granted and
the conditions under which this authorisation is granted; 
(b)     the movements of those aquatic animals
take place under the supervision of the competent authorities of the place of
origin, the place of destination, and where relevant, the competent authority
of the Member State of passage. 
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning amending and
supplementing the rules for derogations by the competent authorities provided
for in paragraphs 1 and 2 of this Article. 
Article 205
Delegation of power concerning specific requirements and derogations for exhibition,
zoos, pet shops, garden ponds, commercial aquaria and wholesalers
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning:
(a)          specific requirement supplementing
the rules laid down in from Sections 1 to 4 and for the movements of aquatic
animals for the following purposes:
(i)      zoos, pet shops and wholesalers;
(ii)     exhibitions and for sporting,
cultural and similar events; or 
(iii)     intended for commercial aquaria; 
(b)          derogations from Sections 1 to 4
with the exception of Article 190(1) and (3) and Articles 191, 192 and 193
for the movements of aquatic animals referred to in point (a).
Article 206
Implementing power for temporary derogations for movements of specific species
or categories of aquatic animals 
The Commission
shall, by means of implementing acts lay down rules concerning temporary
derogations from the rules laid down in this Chapter for movements of specific
species or categories of aquatic animals where:
(a)          the movement requirements provided for in Article 195, Article196(1),
Articles 197 and 198, Article 199(1) and (2), Article 200 and Articles 201(1),
202(1), 203(1), 204(1) and (2) and the rules adopted pursuant to Articles
196(2), 199(3), 201(2), 202(2), 203(2) and204(3) and Article 205 are not
efficiently mitigating the risks posed by certain movements of those aquatic
animals; or
(b)          the listed disease referred to in Article 8(1)(d)
appears to be spreading despite the movement requirements laid down in
accordance with Sections 1 to 5.
Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 255(2). 
On duly
justified imperative grounds of urgency relating to a listed disease representing
a risk of highly significant impact and taking into account the matters
referred to in Article 205 the Commission shall adopt immediately applicable
implementing acts in accordance with the procedure provided for in Article 255(3).
Article 207
Matters to be taken into account when adopting delegated and implementing acts
provided for in this Section
The Commission shall take the following
matters into account, when establishing the rules to be laid down in the
delegated and implementing acts provided for in Articles 203(2), 204(3) and
Articles 205 and 206:
(a)          the risks involved with the
movement;
(b)          the health status as regards the listed
diseases 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 establishment and concerned species or category of
aquaculture animals;
(g)          other epidemiological factors.
Section 6
Animal health certification
Article 208
Obligation of operators to ensure that aquaculture animals are accompanied by
an animal health certificate 
1.           Operators shall only move
aquaculture animals if they are accompanied by an animal health certificate
issued by the competent authority at the place of origin in accordance with
Article 216(1) when they are of listed species for the listed diseases referred
to in point (a) and they are being moved or one of following purposes: 
(a)     they are intended for introduction
into a Member State, or zone or compartment thereof which has been declared
disease- free in accordance with Articles 36(3) and 37(4) or for which a
eradication programme has been established as provided for in Article 30(1) or
(2) as regards one or more of the listed diseases referred to in Article 8(1)(b)
and (c); and
(b)     they are intended for one of the
following purposes:
(i)      an aquaculture establishment;
(ii)      release into the wild;
(iii)     human consumption.
2.           Operators shall only move
aquaculture animals if they are accompanied by an animal health certificate
issued by the competent authority at the place of origin in accordance with
Article 216(1) when they are of listed species for the relevant disease(s) referred
to in point (a) and they are being moved or one of following reasons:
(a)     they are allowed to leave a restricted
zone subject to disease control measures provided for in Article 55(1)(f)(ii), Articles
56 and 64, Articles 65(1), 74(1), 78(1) and (2) or the rules adopted pursuant
to Article 55(2), Articles 67 and68, Articles 71(3) and 74(3), Article 79,
Article 81(2) and Article 248 for one or more of listed diseases referred
to in Article 8(1)(a) and (b); 
(b)     they are intended for one of the
following uses:
(i)      an aquaculture establishment;
(ii)      released into the wild;
(iii)     human consumption.
3.           Operators shall take all
necessary measures to ensure that the animal health certificate accompanies the
aquaculture animals from their place of origin to their place of destination,
unless specific measures are provided for in rules adopted pursuant to Article
214. 
Article 209
Obligation of operators to ensure that other aquatic animals are accompanied by
an animal health certificate and implementing power
1.           Operators shall only move aquatic
animals other than aquaculture animals referred to in Article 208(1) and (2) if
they are accompanied by an animal health certificate issued by the competent
authority at the place of origin in accordance with Article 216(1) where, due
to the risk involved with the movement of those aquatic animals, animal health
certification is necessary to ensure compliance with the following movement
requirements for the listed species of animals:
(a)     the requirements provided for in Sections
1 to 5 and the rules adopted pursuant to those Sections; 
(b)     disease control measures provided for
in Article 55(1), Article 56, Article 61(1), Articles 62 and 64, Articles 65(1),
74(1) and 78(1) and (2) or the rules adopted pursuant to Article 55(2), Articles
63, 67 and 68, Articles 71(3) and 74(3), Article 79 and Article 81(2);
(c)     emergency measures provided for in the
rules adopted pursuant to Article 248.
2.           Article 208 shall also apply to wild
aquatic animals intended for an aquaculture establishment, unless the competent
authority of origin concludes that the certification is not feasible due to the
nature of the place of origin of those wild aquatic animals.
3.           The Commission shall, by means of
implementing acts, lay down rules concerning the obligation of operators,
provided for in paragraph 2 of this Article, to ensure that wild aquatic
animals intended for an aquaculture establishment are accompanied by an animal
health certificate. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
Article 210
Member States' derogation for national animal health certification 
By way of derogation from the animal health
certification requirements of Articles 208 and 209 Member States may grant
derogations for movements of certain consignments of aquatic animals without an
animal health certificate within their territories provided that they have an
alternative system in place to ensure that such consignments are traceable and
they comply with the animal health requirements for such movement provided for
in Sections 1 to 5.
Article 211
Delegation of powers concerning animal health certification for aquatic animals
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning: 
(a)          derogations from the animal
health certificate requirements provided for in Articles 208 and 209 and
the conditions for such derogations, for movements of aquatic animals which do
not pose significant risk of the spread of diseases due to:
(i)      the categories, live stage or species
of the aquatic animals; 
(ii)     the methods of keeping and the type
of production of those species and categories of aquaculture animals;
(iii)     the intended use of the aquatic
animals; 
(iv)    the place of destination of the
aquatic animals; 
(b)          special rules for animal health
certification provided for in Articles 208 and 209 where alternative risk
mitigating measures taken by the competent authority, ensure:
(i)      the traceability of the aquatic
animals; 
(ii)     that the aquatic animals being moved
comply with required animal health conditions provided for in Sections 1 to 5. 
(c)          detailed rules on the animal health certificates
required to accompany movements of aquatic animals for scientific purposes
referred to in Article 204(1). 
Article 212
Contents of animal health certificates
1.           The animal health certificate
shall contain at least the following information: 
(a)     the establishment or place of origin,
the establishment or place of destination and where relevant for the spread of
diseases, any establishment or place visited en route;
(b)     a description of the aquatic animals; 
(c)     the number, volume or weight of
aquatic animals;
(d)     the necessary information needed to
demonstrate that the animals comply with the movement requirements provided for
in Sections 1 to 5.
2.           The animal health certificate may
include other information required under other Union legislation. 
Article 213
Delegation of powers and implementing acts concerning the content of animal
health certificates 
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the content
of animal health certificates provided for in Article 212(1):
(a)     detailed rules on the content 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
implementing acts, lay down rules concerning the model forms for the animal
health certificates. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Article 214
Operators obligation to ensure that animal health certificates accompany the aquatic
animals to the place of destination and delegated acts
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning specific measures
supplementing the requirements for animal health certification provided for in
Article 208 for the following types of movements of aquatic animals:
(a)          movements of aquatic animals,
which may not continue their route to their final place of destination and are
required to return to their place of origin or be moved to a different
destination, for one or more of the following reasons:
(i)      their intended route was unexpectedly
interrupted for animal welfare reasons; 
(ii)     unpredicted accidents or events on
the route;
(iii)     the aquatic animals were rejected at
the place of the destination in another Member State or at the external border of
the Union; 
(iv)    the aquatic animals were rejected in a
third country;
(b)          movements of aquaculture animals
intended for exhibitions and sporting, cultural and similar events, and their
subsequent return to their place of origin. 
Article 215
Operators obligation to cooperate with the competent authorities for animal
health certification purposes
Operators shall: 
(a)          provide the competent authority
with all the information necessary to complete the animal health certificate
provided for in Articles 208 and 209 and the rules adopted pursuant to Articles
211, 213 and 214; 
(b)          where necessary, subject the aquatic
animals to identity, physical and documentary checks as provided for in Article
216(3) and the rules adopted pursuant to Article 216(4). 
Article 216
Competent authority responsibility for animal health certification and delegated acts
1.           The competent authority shall,
upon request by the operator, issue an animal health certificate for the
movement of aquatic animals, where required by Articles 208 and 209, or by
rules adopted pursuant to that Articles 211 and Article 214 provided that the following
animal health requirements have been complied with, as relevant:
(a)     those provided in Article 190, Article
191(1), Articles 192, 194 and 195, Article196(1), Articles 197 and 198, Article 199(1)
and (2), Article 200, Articles 202(1), 203(1) and 204(1) and (2);
(b)     those provided in delegated acts
adopted pursuant to Articles 191(2), 196(2), 199(3), 200(3), 201(2), 202(2),
203(2) and 204(3) and Article 205;
(c)     those provided for in implementing
acts adopted pursuant to Article 206.
2.           Animal health certificates shall:
(a)     be verified and signed by the official
veterinarian;
(b)     remain valid for a period of time,
provided for in the rules adopted pursuant to paragraph 4(b), during which time
the aquaculture animals covered by it, must continue to comply with the animal
health guarantees contained in it.
3.           The official veterinarian shall,
before signing an animal health certificate verify that the aquatic animals covered
by it comply with the requirements of this Chapter by means of documentary,
identity and physical checks as provided for by delegated acts adopted pursuant
to paragraph 4 where appropriate, taking into account the species and categories
of aquatic animals concerned and the animal health requirements.
4.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 laying down rules concerning:

(a)     the types of documentary, identity and
physical checks and examinations for different species and categories of
aquatic animals that must be carried out by the official veterinarian in
accordance with paragraph 3 of this Article to verify compliance with the
requirements of this Chapter; 
(b)     the timeframes for the carrying out of
such documentary, identity and physical checks, examination and the issuing of
animal health certificates by the official veterinarian prior to the movement of
consignments of aquatic animals.
Article 217
Electronic health certificates
Electronic animal health certificates, produced,
handled and transmitted by means of IMSOC, may replace accompanying animal health
certificates provided for in Article 208 where such electronic animal health
certificates:
(a)          contain all the information that
the model animal health certificate is required to contain in accordance with Article
212(1) and the rules adopted pursuant to Article 213; 
(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
another Member State and ensure that it accompanies such aquaculture animals,
where they are not required to be accompanied by an animal health certificate provided
for in Articles 208 and 209 or rules adopted pursuant to that Articles 211 and
Article 214. 
2.           The self-declaration document provided
for in paragraph 1 shall contain at least the following information concerning
the aquaculture animals:
(a)     their places of origin and destination,
and when relevant any places en route;
(b)     a description of the aquaculture
animals, 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 provided for
in Sections 1 to 5.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning:
(a)     detailed rules on the content of the self-declaration
document provided for in paragraph 2 of this Article for different species and categories
of aquaculture animals; 
(b)     additional information to be contained
in the self-declaration document to the one provided for in paragraph 2 of this
Article. 
4.           The Commission may, by means of
implementing acts, lay down rules for a model form of the self-declaration
document provided for in paragraph 1 of this Article. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Section 7
Notification of movements of aquatic animals to other Member States
Article 219 
Obligation of operators concerning the notification of movements of aquatic
animals between Member States
Operators shall notify the competent
authority in their Member State of origin in advance of the intended movement
of aquatic animals from one Member State to another Member State where:
(a)          the aquatic animals are required
to be accompanied by an animal health certificate issued by the competent
authority of the Member State of origin in accordance with Articles 208
and 209 or rules adopted pursuant to Article 211 and Article 214(2);
(b)          the aquatic animals are required
to be accompanied by an animal health certificate for aquatic animals when they
are being moved from a restricted zone as referred to in Article 208(2)(a);
(c)          the aquaculture animals and wild
aquatic animals being moved are intended for: 
(i)      an establishment subject to
registration in accordance with Article 171 or approval in accordance with Articles
174 to 177;
(ii)     for release into the wild;
(d)          notification is required in
accordance with the delegated acts adopted pursuant to Article 221.
For the purposes of the notification
provided for in the first paragraph of this Article, the operators shall
provide the competent authority of the Member State of origin with all the
necessary information to enable it to notify the movement to the competent
authority of the Member State of destination in accordance with Article 220(1).
Article 220 
The responsibility of the competent authority for the notification of movements
of aquatic animals to other Member States
1.           The competent authority of the
Member State of origin shall notify the competent authority of the Member State
of destination of movements of aquatic animals as referred to in Article 219(1),
unless a derogation has been granted in accordance with Article 221(1)(c) for
such notification.
2.           The notification referred to in
paragraph 1 of this Article 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 provided 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 competent authority of the Member State of destination.
Article 221
Delegation of powers and implementing acts for the notification of movements of
aquatic animals by the competent authority
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning: 
(a)     the requirement for notification by
operators in accordance with Article 219(1) of movements between Member States of
aquatic animals of categories or species other than those referred to in Article
219(1)(a), (b) and (c) where traceability of such movements is necessary to
ensure compliance with the animal health requirements laid down in this Chapter;

(b)     the information necessary to notify
movements of aquatic animals by operators and the competent authority as
provided for in Articles 219(1) and 220(1);
(c)     derogations from the notification
requirements provided for in Article 219(1)(c) for categories or species of aquatic
animals or types of movements which pose an insignificant risk;
(d)     the emergency procedures for notification
of movements of aquatic animals in the case of power cuts or other disturbances
of the IMSOC system;
(e)     the requirements for the designation
of regions by Member States provided for in Article 220(3).
2.           The Commission may, by means of
implementing acts, lay down rules concerning: 
(a)     the format of notifications by:
(i)      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
Member State of origin to the Member State of destination of movements of aquatic
animals in accordance with Article 220(1);
(b)     the deadlines for: 
(i)      the necessary information to be
provided to the competent authority of the Member State of origin by operators referred
to in Article 219(1); 
(ii)      the notification of movements by the
competent authority of the Member State of origin referred to in Article 220(1).
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Chapter 3
Movements within the Union of aquatic pet animals 
Article 222
Non-commercial movements of aquatic pet animals and delegated and implementing
acts
1.           Pet keepers shall only carry out
non-commercial movements of aquatic pet animals of the species listed in Annex
I if appropriate disease prevention and control measures have been taken to
ensure that they do not pose a significant risk for the spread of listed
diseases referred to in Article 8(1)(d) and emerging diseases to animals at the
place of destination and during transport.
2.           Article 112 and the rules laid
down in delegated acts pursuant to Article 114(f) and in implementing acts
adopted pursuant to Article 117 shall apply for the identification,
registration and traceability of aquatic pet animals.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the disease
prevention and control measures referred to in paragraph 1 of this Article to
ensure that the aquatic pet animals do not pose a significant risk for the
spread of diseases referred to in Article 8(1)(d) and emerging diseases to
animals during transport and at the place of destination, when relevant taking
into account the health status of the place of destination.
4.           The Commission may, by means of
implementing acts lay down rules concerning the disease prevention and control
measures provided for in paragraph 1 of this Article and the rules adopted
pursuant to paragraph 2 thereof.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Chapter 4
Production, processing and distribution within the Union of products of
animal origin from aquatic animals, other than live aquatic animals 
Article 223
General animal health obligations for operators and delegated acts
1.           Operators shall take appropriate
preventive measures to ensure that during all stages of the production,
processing and distribution of products of animal origin from aquatic animals, other
than live aquatic animals in the Union, those products do not cause the spread
of: 
(a)     listed diseases referred to in Article
8(1)(d) taking into account the health status of the place of production,
processing and destination;
(b)     emerging diseases.
2.           Operators shall ensure that
products of animal origin from aquatic animals, other than live aquatic animals
do not come from either establishments or food business establishments or are obtained
from animals, which come from either establishments food business establishments
subject to: 
(a)     emergency measures provided for in
Articles 246 and 247 and rules adopted pursuant to Article 248 unless
derogations have been provided for those rules in Part VI;
(b)     movement restrictions applicable to
the aquatic animals and products of animal origin from aquatic animals, as
provided for in Articles 31(1) and 55(1), Article 56, Article 61(1)(a), Article
62(1), Articles 65(1)(c), 70(1)(b) and 74(1)(a), Articles 78(1) and (2), and 80(1)
and (2) and the rules adopted pursuant to Article 55(2), Articles 63 and 67,
Articles 71(3) and 74(3) and Article 79 and Article 80(3) and 81(2) unless
derogation have been provided for in those rules.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning detailed
requirements supplementing paragraph 2 of this Article for movements of
products of animal origin from aquatic animals other than live aquatic animals,
taking into account: 
(a)     the diseases and species of aquatic
animals concerned by the disease, for which emergency measures or movement
restrictions referred to in paragraph 2 apply;
(b)     the types of products of animal origin
from aquatic animals;
(c)     the risk mitigating measures applied to
the products of animal origin from aquatic animals at the places of origin and
destination; 
(d)     the intended use of the products of animal
origin from aquatic animals; 
(e)     the place of destination of the products
of animal origin from aquatic animals.
Article 224
Animal health certificates and delegated acts
1.           Operators shall only move the
following products of animal origin from aquatic animals other than live
aquatic animals where they are accompanied by an animal health certificate
issued by the competent authority at the place of origin in accordance with paragraph
3: 
(a)     products of animal origin from aquatic
animals that are allowed to leave a restricted zone subject to emergency
measures provided for in rules adopted pursuant to Article 248 and such products
of animal origin originate from aquatic animals of species subject to those emergency
measures; 
(b)     products of animal origin from aquatic
animals that are allowed to leave a restricted zone subject to disease control
measures in accordance with the Articles 31(1), Article 55(1)(c), Article 56, Article
61(1)(a), Articles 62(1) and 63(1), Article 65(1)(c), 70(1)(b) and 74(1)(a), Articles
78(1) and (2), 80(1) and (2) and the rules adopted pursuant to Article 55(2), Articles
63 and 67, Articles 71(3) and 74(3), Article 79 and Articles 80(3) and
81(2) and such products of animal origin originate from aquatic animals of
species subject to those disease control measures.
2.           Operators shall take all
necessary measures to ensure that the animal health certificate referred to in
paragraph 1 accompanies the products of animal origin from their place of
origin to their place of destination.
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 rules adopted pursuant to Article 213 and Article 216(4) shall
apply to the certification of movements of products of animal origin other than
live aquatic animals, referred to in paragraph 1 of this Article.
5.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning requirements
and detailed rules on the animal health certificate to accompany products of
animal origin other than live aquatic animals, referred to in paragraph 1 of
this Article taking into account: 
(a)     the types of products of animal
origin;
(b)     the risk mitigating measures applied to
the products of animal origin which reduce the risks of the spread of diseases;

(c)     the intended use of the products of
animal origin; 
(d)     the place of destination of the
products of animal origin. 
Article 225
Content of animal health certificates and delegated and implementing acts
1.           The animal health certificate for
products of animal origin other than live aquatic animals shall contain at
least the following information: 
(a)     the establishment or the place of
origin and the establishment or place of destination;
(b)     a description of the products of
animal origin; 
(c)     the quantity or the volume of the products
of animal origin;
(d)     the identification of the products of
animal origin, when required by Article 65(1)(h) or rules adopted 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 adopted pursuant to
Article 223(3).
2.           The animal health certificate for
products of animal origin other than live aquatic animals may include other
information required under other Union legislation. 
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning amending and
supplementing the information to be contained in the animal health certificate as
provided for in paragraph 1 of this Article.
4.           The Commission may, by means of
implementing acts, lay down rules concerning model forms of animal health
certificates provided for in paragraph 1 of this Article. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Article 226
Notification of movements of products of animal origin to other Member States
1.           Operators shall:
(a)     inform
the competent authority in their Member State of origin in advance of the
intended movement of products of animal origin, other than live aquatic
animals, when the consignments are required to be accompanied with an animal
health certificate in accordance with Article 224(1);
(b)     provide all necessary information to
enable the competent authority of the Member State of origin to notify the
movement of products of animal origin, other than live aquatic animals, to the
Member State of destination in accordance with paragraph 2.
2.           The competent authority of the
Member State of origin shall notify the competent authority of the Member State
of destination of movements of products of animal origin, other than live
aquatic animals, in accordance with Article 220(1).
3.           Articles 219 and 220 and rules
adopted pursuant to Article 221 shall be applicable to the notification of
products of animal origin other than live aquatic animals. 
Chapter 5
National measures
Article 227 
National measures for limiting the impact of diseases other than listed disease
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 Member State, the Member State concerned may take national
measures to prevent the introduction of or to control the spread of that
disease.
Member States shall ensure that those national
measures do not exceed the limits of what is appropriate and necessary to
prevent the introduction of or to control the spread of the disease within the
Member State.
2.           Member States shall notify the
Commission in advance of any proposed national measures referred to in
paragraph 1 that may affect movements between Member States. 
3.           The Commission shall approve and
if necessary amend the national measures referred to in paragraph 2 of this
Article by means of implementing acts. Those implementing acts shall be adopted
in accordance with the examination procedure referred to in Article 255(2).
4.           The approval referred to in
paragraph 3 shall only be granted where the establishment of movement
restrictions between Member States is necessary to prevent the introduction of
or to control the spread of the disease referred to in paragraph 1, taking into
account the overall impact of the disease and the measures taken on the Union.
TITLE III
Animals of species other than those defined as terrestrial and aquatic animals,
and germinal products and products of animal origin from such other animals
Article 228
Animal health requirements concerning other animals, and germinal products and
products of animal origin of such other animals
Where other
animals are listed species for a listed disease referred to in Art 8(1)(d), and
those other animals, or their germinal products or products of animal origin
represent a risk to public or animal health: the following animal health
requirements shall apply:
(a)          the requirements concerning registration,
approval, record keeping and registers for establishments and transporters provided
for in Chapters 1 of Titles I and II;
(b)          the requirements concerning traceability
provided for in Articles 102 to 105 and Articles 112 and 113 for other animals
and Article 119 for germinal products; 
(c)          movement requirements:
(i)      for other animals mainly living in
terrestrial environment or are normally affected by diseases of terrestrial
animals, taking into account the criteria provided for in paragrapah 3(d) and
(e) of Article 229, provided for in Section 1 and Section 6 of Chapter 3 of
Title I of Part IV, Chapers 4 and 5 of Title I of Part IV; 
(ii)     for other animals mainly living in
aquatic environment or that are normally affected by diseases of aquatic
animals, taking into account the criteria provided for in Article 229(3)(d) and
(e), the requirements provided for in Sections 1 to 5 of Chapter 2 of Title II
of Part IV and Chapter 2 of Title II;
(iii)     for other pet animals, the
requirements provided for in Articles 112 and 152;
(iv)    for germinal products the general
requirements for movements provided for in Articles 155 and 156 and the special
requiremments for movements to other Member States provided for in Articles 162
and 163;
(v)     for products of animal origin, the
general animal health obligations for operators for the production, processing
and distribution within the Union of products of animal origin provided for in
Articles 164 and 223; 
(d)          the following animal health certification
obligation for operators and the competent authority and self-declaration for
operators: 
(i)      for other animals, pursuant to the rules
provided for in Articles 140 to 148 or Articles 208 to 218;
(ii)     for germinal products, pursuant to
the rules provided for in Articles 159 and 160;
(iii)     for products of animal origin,
pursuant to the rules provided for in Articles 165 and 166 or Articles 224 and 225;
(e)          notification of movements by
operators and by the competent authority, taking into account the requirements
provided for in Articles 149, 150,151, 161, 167 and in Articles 219 to 221
and 226.
Article 229
Delegation of powers and implementing acts concerning animal health requirements
for other animals, and germinal products and products of animal origin of other
animals
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning supplementing
and amending the requirements for other animals, and their germinal products or
products of animal origin, as provided for in Article 228, which are
necessary to mitigate the risk of the diseases referred to therein, concerning:
(a)     the requirements on registration,
approval, record keeping and registers for establishments keeping or
transporters transporting other animals, and their germinal products or
products of animal origin, as provided for in Article 228(a); 
(b)     traceability requirements for other animals
and their germinal products, as provided for in Article 228(b); 
(c)     movement requirements for other
animals and their germinal products and products of animal origin, as provided
for in Article 228(c);
(d)     requirements on animal health certification
obligations by operators and the competent authority and self-declaration
obligations by operators for other animals and their germinal products and
products of animal origin, as provided for in Article 228(d); 
(e)     requirements on notification of movement
by operators and the competent authority for other animals and their germinal
products and products of animal origin, as provided for in Article 228(e).
2.           The Commission may adopt implementing
acts concerning detailed rules for the implementation of the disease control
and prevention measures provided for in paragraph 1 of this Article.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
3.           The Commission shall take one or
more of the following criteria into account when adopting the delegated acts
and implementing acts provided for in paragraphs 1 and 2:
(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
provided 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
effectiveness of disease prevention and control measures for the listed species
concerned by such measures;
(d)     the prevailing terrestrial or aquatic
living evnvironment of those other animals; 
(e)     the type of diseases that are
affecting such other animals, which can be either diseases normally affecting
terrestrial or normally affecting aquatic animals, regardles of the prevailing
living environment referred to in point (b). 
PART V
ENTRY INTO THE UNION AND EXPORT
Chapter 1
Entry into the Union of animals, germinal products and products of
animal origin from third countries and territories 
Section 1
Requirements for the entry into the Union
Article 230
Requirements for entry into the Union of animals, germinal products and
products of animal origin 
1.           Member States shall only permit the
entry into the Union of
consignments of animals, germinal products and products of animal origin from
third countries or territories if they comply with the following
requirements:
(a)     they come from a third country or
territory, listed in accordance with Article 231 for the particular species and
category of animals, or germinal products or products of animal origin, or zone
or compartment thereof, unless they are covered by a derogation or additional
rules adopted pursuant to Article 241(1); 
(b)     they come from establishments which
are approved and listed where such approval and listing is required by Article
234 and rules adopted pursuant to Article 235; 
(c)     they comply with the animal health
requirements for entry into the Union laid down in delegated acts adopted
pursuant to Article 236(1), where such requirements are laid down for the
animal, germinal product or product of animal origin of the consignment;
(d)     they are accompanied by an animal
health certificate, declarations and other documents where required by Article 239(1)
or rules adopted pursuant to Article 239(4); 
2.           Operators shall present consignments of animals,
germinal products and products of animal origin from third countries or
territories for the purposes of official control provided for in Article 45 of Regulation
(EU) No XXX/XXX [Publication office: enter number], unless derogation is
provided for pursuant to that Regulation at the point of entry into the Union.
Section 2
Listing of third countries and territories
Article 231
Lists of third countries and territories from which the entry into the Union of
animals, germinal products and products of animal origin is permitted and
implementing and delegated acts
1.           The Commission shall, by means of
implementing acts, draw up lists of third countries and territories from which the
entry into the Union of specific species and categories of animals, germinal
products and products of animal origin shall be permitted, taking into account
the following criteria:
(a)     the animal health legislation of the
third country or territory and the rules on the entry into that country or
territory of animals, germinal products and products of animal origin from
other third countries and territories;
(b)     the
assurances provided by the competent authority of the third country or
territory concerning the efficient implementation and control of the animal
health legislation referred to in point (a);
(c)     the organisation, structure, resources
and legal powers of the competent authority in the third country or territory; 
(d)     the animal health certification
procedures in the third country or territory;
(e)     the animal health status of the third
country or territory, or zones and compartments thereof, with regard to: 
(i)      listed diseases and emerging
diseases; 
(ii)      any aspects of animal and public
health or the environmental situation in the third country or territory, or
zone or compartment thereof, which may pose a risk to the animal or public health
or the environmental status of the Union;
(f)      the guarantees which the competent
authority of the third country or territory can provide regarding compliance or
equivalence with the relevant animal health requirements applicable in the
Union;
(g)     the regularity and speed with which
the third country or territory supplies the information concerning infectious
or contagious animal diseases in its territory to the World Organisation for
Animal Health (OIE), in particular information concerning the diseases listed
in the Aquatic or Terrestrial Animal Health Codes of the OIE;
(h)     the results of Commission controls
carried out in the third country or territory;
(i)      any experience gathered from previous
entries of animals, germinal products and products of animal origin from the
third country or territory and the results 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 territories provided for in paragraph 1, and
provided that such lists have not been drawn up pursuant to the Union
legislation referred to in Article 258(2), Member States shall determine from
which third countries and territories specific species or categories of animals,
germinal products or products of animal origin may enter the Union.
For the purposes of the first subparagraph, Member
States shall take into account the criteria for inclusion in the lists of third
countries and territories provided for in paragraph 1(a) to (i) of this Article.

3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning derogations
from paragraph 2 of this Article, limiting the possibility for Member States to
decide from which third countries and territories a specific species or
category of animal, germinal product or product of animal origin may enter the
Union, where necessary due to the risk posed by that specific species or
category of animal, germinal product or product of animal origin.
Article 232
Information to be included in the lists of third countries and territories 
The Commission shall specify the following
information for each third country or territory in the lists provided for in
Article 231(1):
(a)          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 territory of that third country or territory
or only from one or more zones or compartments thereof.
Article 233
Suspension and withdrawal from the list of third countries and territories and
implementing acts
1.           The Commission shall, by means of
implementing acts, suspend or withdraw from the list provided for in Article 231(1)
a third country or territory, or zone or compartment thereof, for any of the
following reasons:
(a)     the third country or territory, or one
or more zones or compartments thereof, no longer complies with the criteria
laid down in Article 231(1), where relevant for the entry into the Union of a particular
species or category of animal, germinal product or product of animal origin;
(b)     the animal health situation in the
third country or territory, or zone or compartment thereof is such that a
suspension or withdrawal from that list is necessary to protect the animal
health status of the Union; 
(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 urgency
relating to a serious risk for the introduction into the Union of a listed
disease referred to in Article 8(1)(d), the Commission shall adopt
immediately applicable implementing acts in accordance with the procedure
referred to in Article 255(3).
2.           The Commission may, by means of
implementing acts, reinsert a third country or territory, or zone or
compartment thereof, that has been suspended or withdrawn from the list
provided for in Article 231(1) for one of the following reasons: 
(a)     for the reasons referred to in
paragraph 1(a) or (c) of this Article, provided that the third country or
territory demonstrates that it complies with the criteria for being listed provided
for in Article 231(1); 
(b)     for the reasons referred to in
paragraph 1(b) of this Article, provided that the third country or
territory provides appropriate guarantees that the animal health situation that
gave rise to that suspension or withdrawal from that list has been resolved or
no longer represents a threat to the animal or public health of the Union; 
(c)     for the reasons referred to in
paragraph 1(d) of this Article, provided that: 
(i)      the third country or territory agreed
to a Commission control being carried out on behalf of the Union in its
territory; and
(ii)      the results of that Commission
control shows that the third country or territory, and zones or compartments
thereof comply with the criteria for being listed provided for in Article 231(1).

Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning rules amending
and supplementing the criteria for suspension and withdrawal of a third country
or territory, or zones or compartments thereof, from the list provided for in
Article 231(1), as provided for in paragraph 1 of this Article. 
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
from a type of establishment for which approval is required in the Union in
accordance with in Article 89(2) and the rules adopted pursuant to Article 89(3)
and Article 90, if that establishment in the third country or territory:
(a)     complies with animal health
requirements in that third country or territory which are equivalent to the
rules for that type of establishments applicable in the Union;
(b)     is approved and listed by the
competent authority of the third country or territory of dispatch. 
2.           The Commission shall collect the
lists of approved establishments referred to in paragraph 1(b) received from
the competent authorities of the third countries or territories.
3.           The Commission shall provide to
the Member States any new or updated lists of approved establishments received
from the third countries or territories and shall make them publicly available.

Article 235
Delegation of powers for approval and listing of establishments 
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning rules derogating from the
requirements of Article 234(1)(b) where alternative risk mitigating measures in
place in the third country or territory provide equivalent guarantees for the
animal health within the Union.
Section 4
Entry into the Union of species and categories of animals, germinal products
and products of animal origin
Article 236
Delegation of powers for animal health requirements for the entry into the
Union of species and categories of animals, germinal products and products of
animal origin
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the animal
health requirements for: 
(a)     the entry into the Union of species
and categories of animals, germinal products and products of animal origin from
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 provided
for in paragraph 1(a) shall: 
(a)     be as stringent as the animal health requirements
laid down in this Regulation and the rules adopted pursuant thereto applicable
to the movement of the species and categories of animals, germinal products or
products of animal origin in question within the Union; or
(b)     be equivalent to the animal health
requirements applicable to the species and categories of animals, germinal
products or products of animal origin provided for in Part IV of this
Regulation.
3.           Pending the adoption of delegated
acts laying down animal health requirements as regards a particular species or
category of animal, germinal product or product of animal origin, provided for
in paragraph 1 of this Article and provided that such requirements have not already
been laid down pursuant to the Union legislation referred to in Article 258(2),
Members State may apply national rules, provided that those rules: 
(a)     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
matters into account when laying down animal health requirements in delegated
acts provided for in Article 236(1), for the entry into the Union of particular
species and categories of animals:
(a)          the listed diseases referred to
in Article 8(1)(d) and emerging diseases; 
(b)          the health status of the Union
concerning the listed diseases referred to in Article 8(1)(d) and emerging
diseases;
(c)          the listed species with regard 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; 
(g)          the intended place of
destination;
(h)          the intended use of the animals; 
(i)           any risk mitigating measures in
place in the third countries or territories of origin or transit, or after the
arrival into the territory of the Union;
(j)           animal health requirements
applicable to movements of those animals within the Union;
(k)          other epidemiological factors;
(l)           international animal health
trade standards, relevant to the species and categories of those animals. 
Article 238
Matters to be taken into account in delegated acts provided for in Article 236 with
regard to the entry into the Union of germinal products and products of animal
origin 
The Commission shall take the following
matters into account when laying down the animal health requirements, in
delegated acts provided for in Article 236(1), for the entry into the Union of
germinal products and products of animal origin:,
(a)          the listed diseases referred to in Article 8(1)(d) and
emerging diseases;
(b)          the health status of the animals from which the
germinal products or products of animal origin originate and of the Union
concerning the listed diseases referred to in Article 8(1)(d) and emerging
diseases;
(c)          the type and nature of particular germinal products or
products of animal origin, treatments, processing methods and other risk
mitigating measures that have been applied at the place of origin, dispatch of consignment
or destination;
(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 products 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.
Section 5
animal health certificates, declarations and other documents
Article 239
Animal health certificates, declarations 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 certificate issued by
the competent authority of the third country or territory of origin; 
(b)     declarations or other documents, where
required by the rules adopted pursuant to paragraph 4(a). 
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 territory in compliance with the certification requirements
equivalent to those laid down in Articles 146(3) or 216(3) and rules adopted
pursuant to Articles 146(4) or 216(4). 
3.           Member States shall permit electronic
animal health certificates that are produced, handled and transmitted by means of
IMSOC, to replace the accompanying animal health certificates referred to in paragraph
1, where such electronic animal health certificates: 
(a)     contain all the information that the
animal health certificate referred to in paragraph 1(a) of this Article is
required to contain in accordance with Article 240(1) and rules adopted
pursuant to Article 240(3); 
(b)     ensure the traceability of the consignments
of animals, germinal products and products of animal origin and links those consignments
to the electronic animal health certificate.
4.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning: 
(a)     derogations from the animal health
requirements provided for in paragraph 1(a), for consignments of animals,
germinal products and products of animal origin and specific rules for the
animal health certification of those consignments, that pose an insignificant
risk to the animal health or public health within the Union, due to one or more
of the following factors:
(i)      the category or species of animals,
germinal products or products of animal origin; 
(ii)      the methods of keeping and types of
production of the animals, germinal products and products of animal origin;
(iii)     their intended use;
(iv)     alternative risk mitigating measures
which are in place in the third countries or territories of origin or transit,
or after the arrival into the territory of the Union, providing equivalent
protection of the animal health and public health of the Union provided for in
this Regulation;
(v)     the provision by the third country or
territory of guarantees that compliance with 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 into the
Union meet the animal health requirements for entry into the Union laid down in
rules adopted pursuant to Article 236(1).
Article 240
Content of animal health certificates 
1.           The animal health certificate
referred to in Article 239(1)(a) shall contain at least the following
information: 
(a)     the name and address of: 
(i)      the establishment or place of origin;

(ii)      the establishment or place of
destination; 
(iii)     where applicable, establishments for
assembly operations or rest of the kept animals;
(b)     a description of the animals, germinal
products or products of animal origin; 
(c)     the number or volume of the animals,
germinal products or products of animal origin;
(d)     where applicable, the identification
and registration of the animals or germinal products;
(e)     the information needed to demonstrate
that the animals, germinal products and products of animal origin in the
consignment comply with the animal health requirements for entry into the Union
provided for in Article 230 and Article 236(3) and the rules adopted
pursuant to Article 236(1) and Article 241. 
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 adopt delegated acts in accordance with Article 253 concerning: 
(a)     the information to be contained in the
animal health certificate referred to in Article 239(1)(a) in addition to that
referred to in paragraph 1of this Article; 
(b)     the information to be contained in declarations
or other documents referred to in Article 239(1)(b).
4.           The Commission may, by means of
implementing acts, lay down rules concerning model forms for the animal health
certificates, declarations and other documents referred to in Article 239(1).
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 255(2). 
5.           Pending the establishment of
rules in delegated and implementing acts adopted pursuant to paragraph 3 and 4 of
this Article, as regards a particular species or categories of animals,
germinal product or product of animal origin, and provided that such rules have
not been laid down pursuant to the Union legislation referred to in Article 258(2),
Members State may apply national rules, provided they comply with the
conditions laid down in paragraph 1 of this Article. 
Section 6 
Derogations and additional requirements for certain categories of animals,
germinal products and products of animal origin
Article 241
Derogations and additional requirements for certain categories of animals,
germinal products and products of animal origin
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning derogations
from the requirements provided for in Article230(1) and Articles 234 and 239 and
additional requirements for the entry into the Union of the following: 
(a)     animals: 
(i)      intended for circuses, events,
exhibitions, display, shows and confined establishments;
(ii)      which are pet animals; 
(iii)     intended to be used for scientific
purposes;
(iv)     for which the Union is not the final
destination;
(v)     which originate in the Union and which
are moved to a third country or territory, and then are moved back to the Union
from that third country or territory;
(vi)     which originate in the Union and which
are transported through a third country or territory en route to another part
of the Union; 
(vii)    which are intended for grazing
purposes on a temporary basis, in the vicinity of the Union borders;
(viii)   which pose an insignificant risk to
the animal health status within the Union;
(b)     products of animal origin: 
(i)      intended for personal use; 
(ii)      for consumption on means of
transport arriving from third countries or territories;
(c)     germinal products and products of
animal origin: 
(i)      intended to be used as trade samples;
(ii)      intended to be used as research and
diagnostic samples; 
(iii)     for which the Union is not the final
destination;
(iv)     which originate in the Union and are
moved to a third country or territory, and then are moved back to the Union
from that third country or territory;
(v)     which originate in the Union and are
transported through a third country or territory en route to another part of
the Union; 
(vi)     which pose an insignificant risk to
the animal health status within the Union.
Those delegated acts shall take into account
the matters referred to in Article 237 and 238.
2.           The Commission may, by means of
implementing acts, lay down rules:
(a)     concerning model forms for the animal
health certificates, declarations and other documents for the categories of
animals, germinal products and products of animal origin referred to in
paragraph 1;
(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). 
Chapter
2
Entry into the Union of certain goods other than animals, germinal
products and products of animal origin from third countries and territories 
Article 242
Disease agents and delegated acts
1.           Any natural or legal person
bringing disease agents into the Union shall: 
(a)     ensure that their entry into the Union
does not pose a risk to animal health or public health within the Union with
regard to listed diseases referred to in Article 8(1)(d) and emerging diseases;
(b)     take appropriate disease control and preventive
measures to ensure that entry into the Union of those disease agents does not
present a risk of bioterrorism. 
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 laying down requirements
for the entry into the Union of disease agents concerning:
(a)     the packaging of disease agents; 
(b)     other risk mitigating measures
required to prevent the release and spread of disease agents.
Article 243
Plant material and delegated and implementing acts
1.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning: 
(a)     specific animal health requirements
for the entry into the Union of plant material, which acts as a path of
transmission of listed or emerging diseases;
(b)     requirements on: 
(i)      animal health certification, taking
into account the rules provided for in Article 239(1)(a) and Article 239 (2)
and (3); or 
(ii)      declarations or other documents,
taking into account the rules provided for in Article 239(1)(b).
2.           The Commission shall lay down the
animal health requirements provided for in paragraph 1 of this Article in the
event of a unfavourable disease situation in third countries or territories
concerning listed diseases referred to in Article 8(1)(d) or emerging diseases,
and by taking into account the following criteria:
(a)     whether a listed or emerging disease
that can be transmitted by means of plant material representing a serious risk
to animal or to human health in the Union;
(b)     the likelihood that animals of listed
species for a particular listed disease or emerging disease will be in direct
or indirect contact with the plant material referred to in paragraph 1;
(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
implementing acts lay down rules indicating, for the plant material referred to
in paragraph 1 of this Article, the codes from the Combined Nomenclature, where
such indication is not provided for by the rules adopted pursuant to Article
45(2)(b) of Regulation (EU) No. XXX/XXX [Number to be added - on official
controls].
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Article 244
Means of transport, equipment, packaging materials, transport water and feed
and fodder and delegated and implementing acts
1.           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 adopt delegated acts in accordance with Article 253 concerning: 
(a)     specific animal health requirements
for the entry into the Union of:
(a)     means of transport for animals,
germinal products, products of animal origin, animal by-products and derived
products; 
(b)     equipment, packaging material or transport
water for animals, germinal products, products of animal origin, animal
by-products and derived products, or feed and fodder which may transmit animal
diseases; 
(b)     requirements on: 
(i)      animal health certification, taking
into account the rules provided for in Article 239(1)(a) and Article 239 (2)
and (3); or
(ii)      declarations or other documents,
taking into account the rules provided for in Article 239(1)(b).
3.           The Commission shall lay down the
animal health requirements provided for in paragraph 2 in the event of a
unfavourable disease situation concerning one or more 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
implementing acts, lay down rules indicating, for the goods referred to in
paragraph 2(a) of this Article, the codes from the Combined Nomenclature, where
such indication is not provided for by the rules adopted pursuant to Article
45(2)(b) of Regulation (EU) No. XXX/XXX [Publication office: No of Regulation]
on official controls.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2). 
Chapter 3 
Export 
Article 245
Export from the Union
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 animals and products takes place in accordance
with the rules for the movement of animals and products between Member States
provided for in Part IV, while taking into account the animal health status within
the third country or territory of destination, or zone or compartment thereof,
with regard to the listed diseases referred to in Article 8(1)(d) and emerging
diseases. 
However, if requested by the competent
authority of the importing third country or territory, or if established by the
laws, regulations, standards, codes of practice and other legal and
administrative procedures in force in that country or territory, export and
re-export from the Union may take place in accordance with those provisions. 
2.           Where the provisions of a
bilateral agreement concluded between the Union and a third country or
territory is applicable, animals and products exported from the Union to that
third country or territory shall comply with those provisions.
PART VI
EMERGENCY MEASURES 
Section 1
Emergency measures concerning movements of animals and products within the
Union and means of transport and other material that may have come into contact
with such animals and products
Article 246
Emergency measures to be taken by the competent authority of the affected
Member State in the event of an outbreak of a listed disease or an emerging
disease or the occurrence of a hazard in their territory
1.           In the event of an outbreak of a
listed disease or an emerging disease, or the occurrence of a hazard which is
likely to constitute a serious risk, the competent authority of the Member
State where it occurred shall, depending on the gravity of the situation and
the disease or hazard in question, immediately take one or more of the
following emergency measures to prevent the spread of the disease or hazard: 
(a)     for listed diseases:
(i)      referred to in Article 8(1)(a) the
disease control measures laid down in in of Chapter 1 of Title II of Part III; 
(ii)      referred to in Article 8(1)(b) and
(c), the disease control measures laid down in Chapter 2 of Title II of Part
III;
(b)     for emerging diseases and hazards:
(i)      movement restrictions on animals and
products originating from the establishments, or where relevant the restricted
zones or compartments, where the outbreak or the hazard occurred, and on means
of transport and other material that may have come into contact with those
animals or products;
(ii)      quarantine of animals and isolation
of products;
(iii)     surveillance and traceability
measures;
(iv)     any emergency disease control
measures provided for in Chapter 1 of Title II of Part III that are appropriate;
(c)     any other emergency measure which it
deems appropriate to effectively and efficiently control and prevent the spread
of the disease or hazard. 
2.           The competent authority referred
to in paragraph 1 shall inform the Commission and the other Member States: 
(a)     immediately of an outbreak or the
occurrence of a hazard referred to in paragraph 1;
(b)     without delay of the emergency
measures taken pursuant to paragraph 1.
Article 247
Emergency measures to be taken by Member States other than the Member State
where the outbreak or hazard occurred 
1.           The competent authority of Member
States other than the Member State where the outbreak or hazard referred to in
Article 246(1) occurred, shall take one or more of the emergency measures
referred to in Article 246(1), where it detects on its territory animals or
products from the Member State referred to in Article 246(1) or means of
transport or any other material that may have come into contact with such
animals and products.
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 emergency measures referred to in Article 246(1) on an interim basis,
depending on the gravity of the situation with regard to animals or products originating
from the establishments or any other locations, or where relevant from the
restricted zones of the Member State where the disease or hazard referred to in
Article 246(1) occurred, or means of transport or other material that may have
come into contact with such animals. 
3.           The competent authority referred
to in paragraph 1 shall inform the Commission and other Member States:
(a)     immediately of the outbreak or
occurrence of a hazard referred to in paragraph 1;
(b)     without delay of the emergency
measures taken pursuant to paragraphs 1 and 2.
Article 248
Commission emergency measures 
1.           In the event of an outbreak or
the occurrence of a hazard, as referred to in Article 246(1) and of emergency
measures taken by the competent authorities of the Member States in accordance
with Articles 246(1) and 247(1) and (2), the Commission shall review the situation
and the emergency measures taken, and adopt, by means of an implementing act
one or more of the emergency measures provided for in Article 246(1)
concerning the animals and products and means of transport and other material
that may have come into contact with those animals or products, in any of the
following cases:
(a)     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;
(c)     the Commission considers it necessary
to approve or replace the measures taken by the competent authorities of the
Member States pursuant to Articles 246(1) and 247(1) and (2) in order to
avoid unjustified disruptions in the movement of animals and products.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
2.           On duly justified imperative
grounds of urgency relating to serious risks of the spread of a disease or a
hazard the Commission may adopt immediately applicable implementing acts in
accordance with Article 255(3).
Section 2
Emergency measures concerning consignments of animals and products originating
from Third countries and territories and means of transport and other material
that may have come into contact with such consignments
Article 249
Emergency measures to be taken by the competent authority of the Member State
Where the competent authority of a Member
State becomes aware of a consignment of animals or products originating from a
third country or territory, or means of transport or materials which may have
come into contact with such a consignment, that is likely to constitute a
serious risk in the Union due to possible infection or contamination by listed
diseases or emerging diseases or hazards, it shall immediately: 
(a)          take one or more of the following
emergency measures necessary to mitigate that risk depending on the gravity of
the situation:
(i)      destruction of the consignment;
(ii)     quarantine of animals and isolation
of products;
(iii)     surveillance and traceability
measures;
(iv)    any disease control measures referred
to in Chapter 1 of Title II of Part III, where appropriate;
(v)     any other emergency measure which it
deems appropriate to prevent the spread of the disease or a hazard into the
Union; 
(b)          immediately inform the Commission
and the other Member States of the risks associated with the consignment in
question and of the origin of the consignment by means of IMSOC.
Article 250
Commission emergency measures 
1.           Where a listed disease, an
emerging disease or a hazard that is likely to constitute a serious risk occurs
or spreads in a third country or territory, or if any other serious animal or
public health reason so warrants, the Commission may, by means of an
implementing act and acting on its own initiative or at the request of a Member
State, adopt one or more of the following emergency measures and, depending on
the gravity of the situation: 
(a)     suspend the entry into the Union of
consignments of animals and products, and means of transport or other material
that may have come into contact with such consignments, which may spread that
disease or hazard into the Union; 
(b)     establish special requirements for the
entry into the Union of consignments of animals and products and means of
transport and other material that may have come into contact with such
consignments, which may spread that disease or hazard into the Union; 
(c)     take any other appropriate emergency
disease control measures to prevent the spread of that disease or hazard into
the Union. 
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
2.           On duly justified imperative
grounds of urgency relating to serious risks, the Commission shall after
consulting the Member State concerned, adopt immediately applicable
implementing acts in accordance with the procedure referred to in Article 255(3).

Article 251
Emergency measures taken by the Member States when the Commission does not act 
1.           Where a Member State requests the
Commission to take emergency measures in accordance with Article 250 and the
Commission has not done so, that Member State: 
(a)     may, pending the adoption of emergency
measures by the Commission in accordance with paragraph 2 of this Article, take
one or more emergency measures referred to in point (a) of Article 249 on an
interim basis in respect of the consignments of animals and products and means
of transport and other material that may have come into contact with such
consignments, originating from the third country or territory referred to in
Article 250(1) depending on the gravity of the situation within its territory; 
(b)     shall inform the Commission and the
competent authorities of the other Member States of such emergency measures
without delay, giving the reason for their adoption. 
2.           The Commission shall review the situation
and the emergency measures taken by the Member State in accordance with
paragraph 1 of this Article and shall, where necessary adopt by means of an implementing
act one or more emergency measures provided for in Article 250.
Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 255(2).
3.           On duly justified imperative
grounds of urgency relating to serious risks, the Commission shall adopt
immediately applicable implementing acts in accordance with the procedure
referred to in Article 255(3). 
PART
VII
COMMON PROVISIONS
TITLE I
Procedural provisions
Article 252 
Amendment to Annexes I and II
The Commission shall be empowered to adopt
delegated acts in accordance with Article 253 concerning amendments to Annexes
I and II in order to take account of technical progress, scientific
developments and changed circumstances in public and animal health.
Article 253
Exercise of the delegation
1.           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
referred to in Articles 4(2), 6(2), 9(2), 11(3), 13(2), 15(2), 16(3), 18(3), 24,
28, 30(4), 31(2), 34(2), 37(5), 39, 41(3), 42(5), 44(1), 47, 48(3), 53(2), 54(3),
55(2), 58(2), 63, 64(4), 67, 68(2), 70(3), 72(2), 73(3), 74(3), 76(2), 79, 80(4),
85(3), 89(3), 92(2), 96(3), 100(1), 103(2), 114, 115, 119(1), 122(2), 128(1),
129(2), 132, 133(2), 134(2), 135(3), 136(4), 137, 141(1), 143(1), 144, 146(4),
148(3), 151(1), 152(2), 154(1), 158, 159(5), 160(3), 162(2), 163(3), 164(3), 165(5),
166(3), 174(3), 179(2), 184(1), 188(1), 191(2), 196(2), 199(3), 200(3), 201(2),
202(2), 203(2), 204(3), 205, 211, 213(1), 214, 216(4), 218(3), 221(1), 222(3),
223(3), 224(5), 225(3), 229(1), 231(3), 233(3), 235, 236(1), 239(4), 240(3), 241(1),
242(2), 243(1), 244(2), 252, 259(2), 260(2) and 261(2) shall be conferred on
the Commission for an indeterminate period of time from(*).
3.           The power to adopt delegated acts
referred to in Article 229(1) shall be conferred on the Commission for a period
of five years from (*).
(*)      Date
of entry into force of the basic legislative act or any other date set by the
legislator.
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 European Parliament or by the Council. A decision of revocation
shall put an end to the delegation of the power specified in that decision. It
shall take effect the day following the publication of the decision in the Official
Journal of the European Union or at a later date specified therein. It
shall not affect the validity of any delegated acts already in force.
5.           As soon as it adopts a delegated
act, the Commission shall notify it simultaneously to the European Parliament
and to the Council.
6.           A delegated act adopted pursuant
to provisions listed in paragraph 2 of this Article and pursuant to Article
229(1) shall enter into force only if no objection has been expressed either by
the European Parliament or by the Council within a period of two months of
notification of that act to the European Parliament and the Council or if,
before the expiry of that period, the European Parliament and the Council have
both informed the Commission that they will not object. That period shall be
extended by two months at the initiative of the European Parliament or the
Council. 
Article 254
Urgency procedure
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 Parliament 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
paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
3.           Where reference is made to this
paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with
Article 5 thereof, shall apply.
TITLE II
Penalties
Article 256
Penalties
The Member States shall lay down the rules
on penalties applicable to infringements of the provisions of this Regulation
and shall take all measures necessary to ensure that those rules are
implemented. The penalties provided for must be effective, proportionate and
dissuasive.
The Member States shall notify those
provisions to the Commission by [date to be inserted: one year from the date
of application of this Regulation] at the latest and shall notify it
without delay of any subsequent amendments affecting them.
TITLE III
Member States measures
Article 257
Member States measures
1.           Member States may apply
additional or more stringent measures within their territories than those laid
down in this Regulation concerning only: 
(a)     responsibilities for animal health provided
for in Chapter 3 of Part I;
(b)     notification within Member States provided
for in Article 16;
(c)     surveillance provided for in Chapter 2
of Part II;
(d)     registration, approval, record keeping
and registers provided for in Chapter 1 of Titles I and Chapter 1 of Title II
of Part IV;
(e)     traceability requirements for kept
terrestrial animals and germinal products provided for in Chapter 2 of Title I
of Part IV.
2.           The national measures referred to
in paragraph 1 shall be in accordance with the rules laid down in this
Regulation and shall not:
(a)     hinder the movement of animals and
products between Member States;
(b)     be in contradiction with the rules
referred to in paragraph 1. 
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,
Decision 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,
–              
Directive 2002/60/EC, 
–              
Directive 2002/99/EC, 
–              
Directive 2003/85/EC, 
–              
Regulation (EU) No[XXX/XXX [Publication
office: Number to be inserted… non-commercial movements of pet animals
and repealing Regulation (EC) No 998/2003], 
–              
Regulation (EC) No 21/2004, 
–              
Directive 2004/68/EC, 
–              
Directive 2005/94/EC,
–              
Directive 2006/88/EC,
–              
Directive 2008/71/EC, 
–              
Directive 2009/156/EC,
–              
Directive 2009/158/EC. 
References to those repealed acts shall be
construed as references to this Regulation and shall be read in accordance with
the correlation table set out in Annex III hereto. 
3.           The acts adopted by the
Commission pursuant to the acts of the Council and the European Parliament
referred to in paragraph 2 shall remain in force in so far as they are not in
contradiction with the rules laid down in this Regulation.
Article 259
Transitional measures related to the repeal of Regulation (EC) No 1760/2000,
Regulation (EC) No 21/2004 and Directive 2008/71/EC
1.           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 adopt delegated acts in accordance with Article 252 concerning the date
on which the acts referred to in paragraph 1 of this Article shall no longer
apply. 
That date shall be the date of application of
the corresponding rules to be adopted pursuant to the delegated acts provided
for in Article 103(2) and Articles 114 and 115 of this Regulation.
Article 260
Transitional measures related to the repeals of Directives 92/66/EEC,
2000/75/EC, 2001/89/EC, 2000/75/EC, 2002/60/EC, 2003/85/EC and 2005/94/EC 
1.           Notwithstanding Article 258(2) of
this Regulation, Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2000/75/EC,
2002/60/EC, 2003/85/EC and 2005/94/EC shall continue to apply until the date to
be determined in a delegated act adopted in accordance with paragraph 2 of this
Article.
2.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 253 concerning the date
on which the Directives referred to in paragraph 1 of this Article shall no
longer apply. 
That date shall be the date of the application
of the corresponding rules to be adopted pursuant to the delegated acts
provided for in Articles 44(1), 47(1) 48(3), 53(1) 54(3) and 58(2), Article 63,
Article 64(4), Article 67, and Articles 68(2) and 70(3) of this Regulation.
Article 261
Transitional measures related to the repeal of Regulation (EU) No [XXX/XXX on
the non-commercial movement of pet animals]
1.           Notwithstanding Article 258(2) of
this Regulation, Regulation (EU) No [XXX/XXX] shall continue to apply until the
date to be determined in a delegated act adopted in accordance with paragraph 2
of this Article.
2.           The Commission shall be empowered
to adopt delegated acts in accordance to Article 253 concerning the date
on which Regulation XXX/XXX shall no longer apply. 
That date shall be the date of the application
of the corresponding rules to be adopted pursuant to the delegated acts
provided for in Article 114(f), and Articles 152(2) and 222(3) of this
Regulation.
Article 262
Entry into force and application
This Regulation shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.
It shall apply from 36 months from the date
of entry into force of the Regulation.
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
ANNEX I 
Species of pet animals
PART A
Dogs (Canis lupus familiaris)
Cats (Felis silvestris catus)
Ferrets (Mustela putorius furo)
PART B
Invertebrates (except bees, and bumble bees and
molluscs and crustaceans) 
Ornamental aquatic animals 
Amphibia
Reptiles
Birds: all species of birds except poultry 
Mammals: rodents and rabbits other than those
intended for food production. 
ANNEX II
Species
of Ungulates
 Taxon || 
 Order || Family || Genera/Species 
 Perissodactyla || Equidae || Equus spp. 
 Tapiridae || Tapirus spp. 
 Rhinoceritidae || Ceratotherium spp., Dicerorhinus spp., Diceros spp., Rhinoceros spp. 
 Artiodactyla || Antilocapridae || Antilocapra ssp. 
 Bovidae || Addax ssp., Aepyceros 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. 
 Tragulidae || Hyemoschus ssp., Tragulus-Moschiola ssp. 
 Proboscidae || Elephantidae || Elephas ssp., Loxodonta ssp. 
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 (partially), 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 and Articles 39, 40, 41(3) and 42(5) and (6) 
 Article 11(1) Article 11(2) Article 11(3) Article 11(4) Article 11(5)-(6) || Article 89(1)(a), 92, 93 and Article 92(2), 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 || - 
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 || - 
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 
 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 || - 
 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 - - 
 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 || Articles 230(1)(d), 239, 240 
 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) - 
 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 (partially), 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 
 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 || - 
 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 
 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 
 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 17(2) Article 17(3) Article 17(4) and (5) || Article 230(1)(a)(b) and (c) 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) 
 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 || - 
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 || - 
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 || - 
 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 
 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 1760/2000 || 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 
 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) 
 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) and (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 || - 
 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) and (3), 65(1)(b) and 67(c) 
 Article 19 || Articles 15, 46 and 47 
 Article 20 || - 
 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 || - 
 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) 
 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 
 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 
 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 || - 
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) and (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) and (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 || - 
 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 10(1)(c) Article 10(2) || - Article 256 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 
 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) 
 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) 
 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 || - 
 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 
 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 
 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 || - 
 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 || - 
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 
 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) Article 15(1)(b) to (d) Article 15(2) || Articles 157 and 158 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 || - 
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