I 
(Legislativ e acts) 
REGUL ATIONS 
REGUL ATION (EU) 2016/429 OF THE EUR OPEAN PARLIAMENT AND OF THE COUNCIL 
of 9 March 2016 
on transmissible animal diseases and amending and repealing certain acts in the area of animal 
health (‘Animal Health Law’) 
(Text with EEA relevance) 
THE EUR OPEAN PARLIAMENT AND THE COUNCIL OF THE EUR OPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 114 and 
Article 168(4)(b) thereof, 
Having regar d to the proposal from the European Commission, 
After transmission of the draf t legislative act to the national Parliaments, 
Having regar d to the opinion of the European Economic and Social Committ ee (1), 
After consulting the Committ ee of the Regions, 
Acting in accordance with the ordinar y legislative procedure (2), 
Whereas: 
(1)  The impact of transmissible animal diseases and the measures necessar y to control those diseases can be 
devastating for individual animals, animal populations, animal keepe rs and the econom y. 
(2)  As recent exper iences have demonstrat ed, transmissible animal diseases may also have a signif icant impact on 
public health and food safety . 
(3)  In addition, adverse inter active effects can be obser ved with regar d 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 distr ibution of disease agents and vect ors, including those affect ing wildlif e. 
(4)  In order to ensure high standards of animal and public health in the Union and the rational development of the 
agriculture and aquaculture sectors , and to increase productivity , animal health rules should be laid down at 
Union level. Those rules are necessar y in order , inter alia, to contr ibute to the compl etion of the intern al mark et 
and to avoid the spread of infectious diseases. Those rules should also ensure, as far as possible, that the existing 
animal health status in the Union is maintained and that consequent improvement of that status is suppor ted. 31.3.2016 L 84/1 Official Jour nal of the European Union EN     
(1)OJ C 170, 5.6.2014, p. 104. 
(2)Position of the European Parliament of 15 Apr il 2014 (not yet published in the Offi cial Jour nal) and position of the Council at first 
reading of 14 December 2015. (5)  The current Union legislation on animal health consists of a series of linked and interr elate d basic acts that lay 
down rules on animal health applying to intra–Un ion trade, entr y into the Union of animals and products, 
disease eradication, veteri nary controls, notificati on of diseases and financia l suppor t in relation to different 
animal species, but an overarc hing legal framework, laying down harmonised principles across the sector, is 
missing. 
(6)  Financial rules relating to the suppor t of animal health objectives are provided for in Regulation (EU) 
No 652/2014 of the European Parliament and of the Council (1) and do not form part of this Regulation. In 
addition, the rules covering the official controls of animal health measures provided for in Regulation (EC) 
No 882/2004 of the European Parliament and of the Council (2) and in Council Directives 89/662/EEC (3), 
90/425/EEC (4), 91/496/EEC (5) and 97/78/EC (6) should be used to regulate official controls in the area of animal 
health. 
(7)  This Regulation does not contain provisions whic h regulate animal welf are. However , animal health and welfare 
are linked: better animal health promot es bette r animal welfare, and vice versa. When disease prevention and 
control measures are carried out in accordance with this Regulation, their effect on animal welfare, understood in 
the light of Article 13 of the Treaty on the Functioning of the European Union (TFEU), should be considered in 
order to spare the animals concer ned any avoidable pain, distress or suffe ring. Animal welf are legislation, such as 
Council Regulations (EC) No 1/2005 (7) and (EC) No 1099/2009 (8), should necessar ily continue to apply and 
should be properly imp lemented. The rules laid down in this Regulation should not duplicat e, or overlap with, 
the rules laid down in that legislation. 
(8)  The Commission's communication of 19 September 2007 on a new Animal Health Strateg y for the European 
Union (2007-2013) where ‘Prevention is better than cure’ aims to promote animal health by placing greate r 
emp hasis 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 adoptio n 
of a sing le and simplified regulatory framew ork for animal health seeking converg ence with internatio nal 
standards while ensur ing a firm commitment to high standards of animal health. 
(9)  The aim of this Regulation is to implement the commitments and visions provided for in that Animal Health 
Strateg y, including the ‘One health’ principle, and to consolidate the legal framew ork for a common Union 
animal health policy through a sing le, simplified and flexible regulatory framew ork for animal health. 
(10)  Animals may suffer from a broad rang e of infec tious or non–infect ious diseases. Man y diseases can be treate d, or 
have an impact only on the individual animal concer ned, or do not spread to other animals or to humans. On 
the other hand, transmissible diseases may have a broader imp act on animal or public health, with effects felt at 
population level. The animal health rules laid down in this Regulation should be limite d to those latter diseases 
alone. 31.3.2016 L 84/2 Official Jour nal of the European Union EN     
(1)Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 laying down provisions for the 
managemen t of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant 
reproductive mat erial, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) 
No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European 
Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council 
Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC (OJ L 189, 27.6.2014, p. 1). 
(2)Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 Apr il 2004 on official controls perfor med to ensure 
the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). 
(3)Council Directive 89/662/EEC of 11 December 1989 concer ning veterinar y chec ks in intra‑Community trade with a view to the 
compl etion of the internal market (OJ L 395, 30.12.1989, p. 13). 
(4)Council Directive 90/425/EEC of 26 June 1990 concer ning veterinar y and zootec hnical chec ks applicable in intra-Community trade in 
certain live animals and products with a view to the completion of the inter nal market (OJ L 224, 18.8.1990, p. 29). 
(5)Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterin ary checks on animals 
entering the Community from third countr ies and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ L 268, 
24.9.1991, p. 56). 
(6)Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisat ion of veterinar y chec ks on 
products enteri ng the Community from third countr ies (OJ L 24, 30.1.1998, p. 9). 
(7)Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transpor t and related operations and 
amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1). 
(8)Council Regulation (EC) No 1099/2009 of 24 Sept ember 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, 
p. 1). (11)  In laying down those animal health rules, it is essential that consideration be given to the links between animal 
health and public health, the environment, food and feed safety , animal welfa re, food secur ity, economic, social 
and cultural aspects. 
(12)  The Sanitar y and Phytosan itary Measures (SPS) Agreement, to whic h the Union is a party, regulates the use of 
measures necessar y to prote ct human, animal or plant life or health so that they do not arbitrar ily or unjustifiably 
discr iminate between World Trade Org anisation (WTO) members. If intern ational standards exist, they are 
required to be used as a basis for Union measures. However , the parties to the SPS Agreement have the right to 
set their own relevant standards, provided that such standards are based on scientific evidence. 
(13)  As regards animal health, the SPS Agreement refers to the standards of the World Org anisation for Animal 
Health (OIE) relating to animal health conditions for internati onal trade. In order to reduce the risk of trade 
disrupti on, Union animal health measures should aim at an appropr iate level of converg ence with OIE standards. 
(14)  In specific circumstances where a significant animal or public health risk exists but scientific uncer tainty persists, 
Article 5(7) of the SPS Agreement, whic h has been interpreted for the Union in the Commission communication 
of 2 Febr uary 2000 on the precautionar y principle, allows members of that Agreement to adopt provisional 
measures on the basis of available pertinent information. In such circumstances, the member concer ned is 
required to obtain the additional information necessar y for a more objective assessment of risk and to review the 
measure according ly within a reasonable period of time. 
(15)  The risk assessment on the basis of which the measures under this Regulation are taken should be based on the 
available scientific evidence and under taken in an independent, objective and transparent manner . Due account 
should also be take n of the opinions of the European Food Safety Authority (EFSA) established by Article 22(1) 
of Regulation (EC) No 178/2002 of the European Parliament and of the Council (1). 
(16)  Regulation (EC) No 1069/2009 of the European Parliament and the Council (2) 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 prot ect the safety of the food and feed 
chain. In order to avoid any overlap of Union legislation, this Regulation should theref ore 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 regulat e how to 
handle animal by–products and derived products in the context of disease control measures, and so those issues 
are duly covered by this Regulation. 
(17)  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 (3), 
Directive 2003/99/EC of the European Parliament and of the Council (4) and Regulation (EC) No 2160/2003 of 
the European Parliament and of the Council (5), and specifi c rules on communicable diseases in humans are laid 
down in Decision No 1082/2013/EU of the European Parliament and of the Council (6). Those acts should 
remain in force following the adop tion of this Regulation. According ly, in order to avoid any overlap of Union 
legislation, this Regulation should only apply to zoonoses to the exte nt that specifi c rules are not already laid 31.3.2016 L 84/3 Official Jour nal of the European Union EN     
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and 
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety 
(OJ L 31, 1.2.2002, p. 1). 
(2)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 inten ded for human consump tion and repealing Regulation (EC) No 1774/2002 (Animal 
by‑products Regulation) (OJ L 300, 14.11.2009, p. 1). 
(3)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 spongif orm encephalopathies (OJ L 147, 31.5.2001, p. 1). 
(4)Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitor ing of zoonoses and 
zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325, 12.12.2003, p. 31). 
(5)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–bor ne zoonotic agents (OJ L 325, 12.12.2003, p. 1). 
(6)Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to 
health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). down in those other Union acts. In addition, this Regulation applies without prejudice to the rules provided for 
in other Union legislative acts, such as in the fields of veterinar y medicine and animal welfare. 
(18)  Diseases occur ring in animals which are kept by humans can have severe impacts on the agriculture and 
aquaculture sector s, on public health, on the environment and on biodiversity . However , as such animals are kept 
by humans, disease prevention and control measures are often easier to apply to them than to wild animals. 
(19)  Never theless, diseases occur ring in wild animal populations may have a detr imental effect on the agriculture and 
aquaculture sector s, on public health, on the envi ronment and on biodiversity . It is theref ore appropr iate that the 
scope of this Regulation should, in such cases, cover wild animals, both as poten tial victims of those diseases and 
as their vect ors. For the purposes of this Regulation, the term ‘wild animals ’ covers all animals that are not kept 
by humans, including stray and feral animals, even if they are of species that are normally domesticat ed. 
(20)  Animal diseases are not only transmitted through direct contact between animals or between animals and 
humans. They are also carried further afield through wate r and air systems , vect ors such as insects, or the semen, 
oocyt es and embr yos used in artificial insemination, oocyte donation or embr yo transfer . Disease agents may also 
be contained in food and other products of animal origin such as leather , fur, feathers, horn and any other 
mate rial derived from the body of an animal. Moreo ver, various other objects such as transpor t vehicles, 
equipment, fodder and hay and straw may diffuse disease agents. Theref ore, effective animal health rules need to 
cover all paths of infection and mater ial involved therein. 
(21)  Animal diseases may have detr imental effects on the distr ibution of animal species in the wild, and thus affect 
biodiversity . Microorg anisms causing such animal diseases can theref ore be considered as invasive alien species 
within the framewor k of the United Nations Conv ention 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, whic h play a role in the transmission of, or are affect ed 
by, diseases covered by this Regulation. 
(22)  Union legislation adopt ed prior to this Regulation lays down separate animal health rules for terrestrial and 
aquatic animals. Council Directive 2006/88/EC (1) lays down specif ic rules for aquatic animals. Yet in most cases, 
the main principles for good animal health governance and good animal husbandr y are applicable to both groups 
of animal species. According ly, this Regulation should cover both terrestrial and aquatic animals and should align 
those animal health rules where applicable. However , for certain aspects, in particular the registration and 
appro val of establishments and the traceability and movements of animals within the Union, this Regulation 
adheres to the approach adopt ed in the past, which was to lay down different sets of animal health rules for 
terrestr ial and aquatic animals due to their differ ent environments and according ly diffe rent requirements to 
safeg uard health. 
(23)  Union legislation adopt ed prior to this Regulation, and in particular Council Directive 92/65/EEC (2), also lays 
down basic animal health rules for other animal species not regulate d in other Union acts, such as reptiles, 
amph ibians, mar ine mammals, and others which are not aquatic or terrestr ial animals as defined in this 
Regulation. Usually , such species do not present a signif icant health risk for humans or other animals and 
theref ore only a few animal health rules, if any, apply . In order to avoid unnecessar y administrative burdens and 
costs, this Regulation should adhere to the approach adopt ed in the past, namely to provide the legal framework 
enabling detailed animal health rules to be laid down for movements of such animals and their products if the 
risks involved so require. 
(24)  Humans often keep certain animals as pets in their households to keep them compan y. The keeping of such pet 
animals for purely private purposes, including ornamental aquatic animals in households, both indoors and 
outdoors, generally poses a lower health risk compared to other ways of keeping or moving animals on a 31.3.2016 L 84/4 Official Jour nal of the European Union EN     
(1)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 (OJ L 328, 24.11.2006, p. 14). 
(2)Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and impor ts into the 
Community of animals, semen, ova and embr yos not subject to animal health requirements laid down in specific Community rules 
referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54). broader scale, such as those common in agriculture, aquaculture, animal shelters and the transpor t of animals 
more generally . Theref ore, it is not appropr iate that the general requirements concer ning registration, record 
keeping and movements within the Union should apply to such pet animals, as this would represent an 
unjustified administrative burden and cost. Registration and record keeping requirements should theref ore not 
apply to pet keepers. In addition, specifi c rules should apply to non–commercial movements of pet animals 
within the Union. 
(25)  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 varied nature of the group concer ned. This is the case for the group of hoof ed 
mammals classif ied as ungulates. The list of such animals may need to be change d in the future due to reasons of 
changed taxonom y. Theref ore, in order to take account of such chang es, the power to adopt acts in accordance 
with Article 290 TFEU should be delegat ed to the Commission in respect of the list of ungulates set out in 
Annex III to this Regulation. 
(26)  Not all transmissible animal diseases can or should be prevented and controlled through regulatory measures, for 
examp le if the disease is too widespread, if diagnostic tools are not available, or if the private sector can take 
measures to control the disease by itself. Regulator y measures to prevent and control transmissible animal 
diseases may have imp ortant economic consequences for the relevant sectors and may disrupt trade. It is 
theref ore essential that such measures are applied only when they are propor tionate and necessar y, such as when 
a disease presents, or is suspect ed to present, a signif icant risk to animal or public health. 
(27)  Further more, the preventive and control measures for each transmissible animal disease should be ‘tailor–made’ 
in order to address its unique epidemiological prof ile, its consequences and its distr ibution within the Union. The 
preventive and control rules applying to each of them should theref ore be disease-specif ic. 
(28) For transmissible animal diseases, a disease condition is usually associate d with clinical or pathological manifes ­
tation of the infection. However , for the purpose of this Regulation, which aims to control the spread of, and 
eradicat e, certain transmissible animal diseases, the disease definition should be wider in order to include other 
carriers of the disease agent. 
(29)  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. Theref ore, they do not represent a serious threat to animal or 
public health in the Union and can thus, if desired, be addressed by means of national rules. 
(30)  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 latte r should, with the assistance of the 
compet ent author ities of the Member States, take action to prevent or control such diseases, for instance through 
self–regulat ory measures or the development of codes of practice. 
(31)  In contrast to the transmissible animal diseases descr ibed in recitals 29 and 30, highly transmissible animal 
diseases may easily spread across borders and, if they are also zoonoses, 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. 
(32)  Antimicrobial resistance, underst ood as the ability of microorganisms to survive or to grow in the presence of a 
concentration of an antimicrobial agent whic h is usually sufficient to inhibit or kill microorga nisms of the same 
species, is increasing. Action No 5 advoc ated in the Communication from the Commission to the European 
Parliament and the Council entitled ‘Action plan against the rising threats from antimicrobial resistance ’ 
emp hasises the preventive role to be played by this Regulation and the consequent expected reduction of the use 
of antibiotics in animals. This resistance of microorganisms to antimicrobials to whic h they were previously 
responsive compl icate s the treatment of infectious diseases in humans and animals and may thus pose a threat to 
human or animal health. As a result, microorg anisms that have developed resistance to antimicrobials should be 
treated as if they were transmissible diseases, and thus covered by the scope of this Regulation. This will enable 
action to be take n against antimicrobial-resistant organisms where appropr iate and necessar y. 31.3.2016 L 84/5 Official Jour nal of the European Union EN     (33)  New hazards associate d with certain diseases or species may develop in particular due to chang es in trade 
patte rns, the environment, the climat e, animal husbandr y and farming traditions, but also as a result of social 
changes . Scientifi c progress may also lead to new kno wledge concer ning, and increased aware ness of, existing 
diseases. Further more, diseases and species that are important today may be marginalised in the future. Theref ore 
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 suppor t of the European Commission, produced a study on the ‘Listing 
and categor isation of priority animal diseases, including those transmissible to humans ’ and a tool for such an 
exer cise, whic h aims to develop a system of disease prioritisation and cate gorisation. That tool is an example of a 
system atic approach to the collection and assessment of information about animal diseases. 
(34)  It is necessar y to establish a harmonised list of transmissible animal diseases (‘listed diseases’) which pose a risk to 
animal or public health in the Union, whether across the whole Union or only in parts. The five diseases already 
identified in this Regulation should be supplemented by a list of diseases set out in an annex. The Commission 
should review and amend that annex in accordance with a set of criteria. The power to adop t acts amending the 
annex should theref ore be deleg ated to the Commission in accordance with Article 290 TFEU. 
(35)  Diseases with the poten tial to pose serious risks to public or animal health and to result in imp acts on health, the 
econom y or the environment may emerg e in the future. Implementing powers to lay down disease prevention 
and control measures for such emerging diseases should be conferred on the Commission to adopt adequate 
measures to address poten tial negative consequences of those diseases even if they have not been fully assessed in 
view of their poten tial listing. Such measures are without prejudice to emergency measures and could continue to 
apply to emerging diseases pending a decision on their listing. 
(36)  Liste d diseases will require differ ent manag ement approaches. Some highly contagious diseases which are 
currently not present in the Union require stringe nt measures to immediately eradicate them as soon as they 
occur . In cases where such diseases are not prom ptly eradicated and become endemic, a long-t erm compulso ry 
eradication programme will be required. For other diseases that may already be present in parts of the Union, 
compul sory or optional eradication is required. In these cases, it is appropr iate to put in place restr ictions on 
movements of animals and products, such as a prohibition of movements to and from affected areas, or simply 
to test the animals or products concer ned prior to dispatch . In other instances it might be appropr iate merely to 
implement a programme of surveillance of the distr ibution of the disease in question, without taking further 
measures. 
(37)  Criteria should be laid down to ensure that all relevant aspects are considered when determining whic h 
transmissible animal diseases should be listed for the purposes of this Regulation. 
(38)  The rules laid down by this Regulation for the prevention and control of a specific transmissible animal disease 
should apply to species of animals whic h can transmit the disease in question, by virtue of being susceptible to it 
or by acting as its vect or. In order to ensure unif orm conditions for the implementation of this Regulation, it is 
necessar y to establish a harmonised list of species to whic h the measures for specifi c listed diseases are to apply 
at Union level (‘listed species’) and implementing powers to lay down such a list should thus be conferred on the 
Commission. 
(39)  The catego risation process should be based on predef ined criteria such as the prof ile of the listed disease in 
question, the level of its impact on animal and public health, animal welf are and the econom y of the Union, the 
risk of its spreading and the availability of disease prevention and control measures in respect of that listed 
disease. Imp lementing powers should be conferr ed on the Commission to lay down whic h listed diseases are to 
be subject to which rules. 
(40)  Such rules should apply as regar ds listed diseases that do normally not occur in the Union and for which 
immediate eradication measures need imperatively to be taken as soon as they are detected , such as classical 
swine fever , as regards listed diseases that need to be controlled in all Member States with the goal of eradicating 
them throughout the Union, which could include diseases such as brucellosis, as regar ds liste d diseases which are 
of relevance to some Member States and for whic h measures are needed to prevent them from spreading to parts 
of the Union that are officially free of, or that have eradication programmes for that, listed disease, whic h could 31.3.2016 L 84/6 Official Jour nal of the European Union EN     include diseases such as infectious bovine rhinotrache itis, as rega rds listed diseases for whic h measures are needed 
to prevent them from spreading on account of their entr y into the Union or movements between Member States, 
whic h could include diseases such as equine infectious anaemia, and as regar ds listed diseases for which there is a 
need for surveillance within the Union, which could include diseases such as anthrax. 
(41)  The disease prof ile of a given disease may change, as well as the risks associated with the disease and other 
circumstances. For such cases, the imp lementing powers conferr ed on the Commission should also include the 
power to modify the categor y into which a particular liste d disease falls, and theref ore the measures to which it is 
subject. 
(42)  Operato rs working with animals are in the best position to obser ve and ensure the health of the animals and to 
monitor products under their responsibility . They should theref ore bear primar y responsibility for carrying out 
measures for the prevention and control of the spread of diseases among animals and the monitori ng of products 
under their responsibility . 
(43)  Biosecur ity is one of the key prevention tools at the disposal of operat ors 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 biosecur ity is also recognised in the impact assessment for the adopt ion of this 
Regulation, in whic h possible impacts are specifical ly assessed. The biosecur ity measures adopt ed should be 
sufficiently flexible, suit the type of production and the species or catego ries of animals involved and take 
account of the local circumstances and technical developments. Implementing powers should be conferr ed on the 
Commission to lay down minimum requirements necessar y for the unif orm application of biosecur ity measures 
in the Member States. Never theless, it should alwa ys remain within the power of operat ors, Member States or the 
Commission to promote prevention of transmissible diseases through higher biosecur ity standards by developing 
their own guides to good practice. While biosecur ity may require some upfront investment, the resulting 
reduction in animal disease should be a positive incentive for operat ors. 
(44)  Biocidal products, such as disinf ectants for vete rinar y hygiene or food and feed areas, insecticides, repellents or 
rodenticides, play an important role in biosecur ity strategies, both at farm level and during animal transpor t. 
They should theref ore be considered part of biosecur ity. 
(45)  Kno wledge of animal health, including of disease symp toms, consequences of diseases and possible means of 
prevention including biosecur ity, treatment and control, is a prerequisite for efficient animal health manag ement 
and essential in ensur ing the early detection of animal diseases. Operato rs and animal professionals should 
theref ore acquire such knowledge as appropr iate. That knowledge may be acquired by diffe rent means, for 
examp le formal education, but also through the Farm Advisor y System existing in the agricultural sector or by 
informal training to which national and Union farmer organisations and other organisations may be valuable 
contr ibutors. 
(46)  Veterinar ians and aquatic animal health professionals play a crucial role in all aspects of animal health 
manag ement, and general rules concer ning their roles and responsibilities should be laid down in this Regulation. 
(47)  Veterinar ians have the education and the professional qualifications attesting to their having acquired the 
kno wledge, skills and compet encies necessar y, inter alia, to diagnose diseases and treat animals. In addition, in 
some Member States for histor ical reasons, or due to the lack of veterinar ians dealing with aquatic diseases, there 
exists a specialised profession called ‘aquatic animal health profe ssionals ’. These profess ionals are traditionally not 
veterinar ians but they practice aquatic animal medicine. This Regulation should theref ore respect the decision of 
those Member State s which recognise that profes sion. In those cases, aquatic animal health profe ssionals should 
have the same responsibilities and oblig ations as veterinar ians concer ning their specifi c area of work. This 
approac h is in line with the OIE Aquatic Animal Health Code. 
(48)  Member States, and in particular their compet ent author ities responsible for animal health, are amongst the key 
actors in the prevention and control of transmissible animal diseases. The compe tent author ity for animal health 31.3.2016 L 84/7 Official Jour nal of the European Union EN     plays an important role in relation to surveillance, eradication, disease control measures, contingenc y planning 
and raising disease awar eness, in the facilitation of animal movements, and in internati onal trade by the issuing 
of animal health certificates. In order to be able to perform their duties under this Regulation, Member States 
depend on having access to adequate financial, infrastr uctural and personnel resources throughout their 
territories, including laborat ory capacity and scientifi c and other relevant kno w–ho w. 
(49)  The compet ent author ity cannot alwa ys perform all the activities required to be carried out by them under this 
Regulation due to limited resources. For that reason, it is necessar y to provide a legal basis for the delegatio n of 
the performa nce of certain activities to veteri narians who are not official veterinar ians. For the same reason, 
Member State s should also be allowed to author ise natural or legal persons to perform certain activities under 
certain conditions. 
(50)  In order to ensure that the necessar y 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 TFEU should be 
delegat ed to the Commission in respect of the deleg ation of the performance of other activities which the 
compet ent author ity may delegat e to veterinar ians other than official veter inar ians. 
(51) Opti mal animal health manage ment can only be achieved in cooperation with animal keepe rs, operat ors, veterina ­
rians, animal health professionals, other stake holders and trading partners. In order to secure their suppor t, it is 
necessar y to organise decision-making procedures and the application of the measures provided for in this 
Regulation in a clear , transparent and inclusive manner . 
(52)  The compet ent author ity should also take appropr iate 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 or 
when a case is of public interest. In those cases, the animals or products concer ned may originate from within 
the Union or enter the Union from outside. The latte r may also be brought into the Union by persons travelling 
from outside the Union with their personal luggag e. Thus, the information provided to citizens should also cover 
the risks involved with such situations. 
(53)  In order to avoid the release of disease agents from laborat ories, institutes and other facilities handling disease 
agents, it is vital that they take appropr iate biosecur ity, biosafety and bio–containment measures. This Regulation 
should theref ore provide for safety measures to be obser ved during the handling or transpor tation of such disease 
agents, vaccines and other biological products. The obligation imp osed in that regard should also apply to any 
legal or natural person who is involved in such an activity . In order to ensure that safety standards are respecte d 
in the handling of highly contagious biological agents, vaccines and other biological products, the power to 
adopt acts in accordance with Article 290 TFEU should be delegat ed to the Commission in respect of the safety 
measures in those laborat ories, institutes and facilities and for movements of disease agents. 
(54)  Early detection and a clear chain of disease notifi cation and repor ting are crucial for effective disease control. In 
order to achieve an efficient and quic k response, Member States should ensure that any suspicion or 
confir mation of an outbreak of certain listed diseases should be immediately notifi ed to the compet ent author ity. 
(55)  Veterinar ians are key actor s in the investigation of diseases and a key link between operat ors and the compet ent 
author ity. They should theref ore be notified by the operat or concer ned in cases of abnor mal mor talities, other 
serious disease problems, or significantly decreased production rates with an undeterm ined cause. 
(56)  In order to ensure the effective and efficient notification of, and to clarify diffe rent circumstances relat ed to, 
abnor mal mor talities and other signs of serious diseases, the power to adopt acts in accordance with Article 290 
TFEU should be delegat ed to the Commission in respect of criteria to determine when relevant circumstances for 
notification occur and to lay down the rules for further investig ation, where this is relevant. 
(57)  For certain listed diseases, it is vital that a Member State should immediat ely notify the Commission and the 
other Member States about an outbreak in its territory. Such notification will enable neighbour ing or other 
affected Member State s to take precautionar y measures when appropr iate. 31.3.2016 L 84/8 Official Jour nal of the European Union EN     (58)  On the other hand, for some diseases immediate notification and action are not necessar y. In those cases, the 
gather ing of information and repor ting in relation to the occur rence of those diseases is essential in order to 
control the disease situation and where necessar y to take disease prevention and control measures. This repor ting 
requirement may also apply to diseases which are subject to Union-wide notifi cation 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 needed to prevent the spread or to control each particular disease 
are collect ed in the right timeframe, the power to adopt acts in accordance with Article 290 TFEU should be 
delegat ed to the Commission concer ning the matters to be repor ted. 
(59) A key purpose of disease notifi cation and repor ting is to generate reliable, transparent and accessible epidemiol ­
ogical data. A comput erised interactive 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 pathogen s. That system should promote optimal data availability , facilitation of data 
exchange, and reduction of administrative burdens for the compet ent author ities of the Member States by 
merging disease notificati on and repor ting within the Union and at intern ational level into a sing le process 
operat ed through the database of the OIE. Steps should also be taken to ensure consistency in exchang es of 
information in accordance with Directive 2003/99/EC. 
(60)  In order to ensure unif orm conditions for the implementation of the Union disease notifi cation and repor ting 
rules, implementing powers should be conferr ed on the Commission to establish a list of diseases which are 
subject to Union notifi cation and Union repor ting rules as provided for in this Regulation and to establish the 
necessar y procedures, formats, data and information exchang es regar ding disease notificati on and repor ting. 
(61)  Surveillance is a key element of disease control policy . It should provide for the early detection of transmissible 
animal diseases and efficient notification thereof, thereby enabling the sector concer ned and the compe tent 
author ity to implement, where feasible, timely disease prevention and control measures, and allowing the disease 
in question to be eradicated. Further more, it should supply information on the animal health status of each 
Member State and of the Union, thereby substantiating certification of freedom from disease and facilitating trade 
with third countr ies. 
(62)  Operato rs obser ve their animals on a regular basis and are best positioned to detec t abnor mal mor talities or 
other serious disease symp toms . Operators are theref ore the cornerstone of any surveillance and essential for the 
surveillance under taken by the compet ent author ity. 
(63)  To ensure close collaboration and exchange of information between operators and veteri narians or aquatic animal 
health profe ssionals, and to supplement the surveillance under taken by operators, establishments should, as 
appropr iate for the type of production concer ned and other relevant factors, be subject to animal health visits. In 
order to ensure unif orm conditions for the carrying-out of animal health visits, implementing powers should be 
conferred on the Commission to lay down minimum requirements. 
(64)  It is essential that the compe tent author ity have in place a system of surveillance for the listed diseases whic h are 
subject to surveillance. This should also apply to emerging diseases, where the poten tial health risks of the 
disease concer ned should be assessed and epidemiological data collect ed for that assessment. In order to ensure 
the best use of resources, information should be collected, shared and used in the most effective and efficient 
manner possible. 
(65)  The surveillance methodology , frequency and intensi ty should be adapt ed to each specific disease and should take 
into account the specifi c purpose of the surveillance, the animal health status in the zone concer ned and any 
additional surveillance conduct ed by operat ors. The appropr iate epidemiological surveillance actions could range 
from a simple notifi cation and repor ting of the occur rence or suspicion of a liste d or an emerging disease, or 
other anomalies, such as abnor mal mor talities and other signs of disease, to a specifi c and compre hensive 
surveillance programme, whic h would normally include additional sampling and testing regimes. 
(66)  Depending on the epidemiological profile of a disease and the relevant risk factors, a specifi c surveillance 
programme comprising defined and structured activities may need to be put in place. In such cases, it is 
appropr iate that Member States develop target ed surveillance programmes. Where such programmes are relevant 
for the Union as a whole, rules should be laid down providing for harmonised application of such programmes. 31.3.2016 L 84/9 Official Jour nal of the European Union EN     (67)  Such programmes should be consistent with Union objectives and theref ore coordinat ed at Union level. To that 
end, they should be submitted to the Commission. Further more, Member States implementing such specifi c 
surveillance programmes should also submit regular repor ts on the results of those programmes to the 
Commission. In order to ensure unif orm conditions for the imple mentation of surveillance programmes, 
implementing powers should be conferr ed on the Commission to establish a list of diseases subject to 
surveillance programmes and to set up harmonised procedures, formats, data, information exchang e and criteria 
to be used for the evaluation of the surveillance programmes. 
(68)  It will often be necessar y to provide details about the appropr iate format of surveillance for differ ent diseases, 
ranging from those diseases where surveillance can be limited to activities such as repor ting and notification to 
diseases where an in–depth Union–wide specific surveillance programme needs to be established. Theref ore, the 
power to adopt acts in accordance with Article 290 TFEU should be delegat ed to the Commission concer ning the 
surveillance design, the criteria to establish the relevance of a disease to be subject to a surveillance programme 
relevant for the Union and for official confir mation of outbreaks, the case definit ions of the diseases concer ned 
and requirements for surveillance programmes in relation to their cont ent, the information to be included in such 
programmes and their period of application. 
(69)  Member States that are not free or are not known to be free from listed diseases whic h are subject to eradication 
measures as provided for in this Regulation should be required to establish compul sory eradication programmes 
to eradicat e those diseases where eradication is compulsor y in the Union. 
(70)  On the other hand, there are some diseases which are of Union concer n but for whic h it is not necessar y to 
require Member State s to eradicat e the disease in question. It should be open to Member States to establish 
optional eradication programmes for such diseases if they decide that eradication is impor tant for them. Such 
optional eradication programmes would be recognised at Union level and would entail the implementation of 
certain relevant disease control measures. They may also enable the Member State concer ned, subject to appro val 
by the Commission, to require certain guarant ees when receiving animals from other Member States or from 
third countr ies. 
(71)  In order to ensure unif orm conditions for the implementation of disease eradication programmes, implementing 
powers should be conferr ed on the Commission to lay down the procedures for the submission of such 
programmes, performa nce indicators , and repor ting. 
(72)  Further more, a Member State should have the possibility of declar ing the whole of its territori es, zones or 
compar tments thereof free of one or more of listed diseases which are subject to rules on compulso ry or 
optional eradication programmes, in order to be prot ected against the introduction of such listed diseases from 
other parts of the Union or from third countr ies or territories. A clear harmonised procedure, including the 
necessar y criteria for disease–free status, should be established for that purpose. In order to ensure unif orm 
conditions for the implementation of the recognition of disease–free status within the Union, it is necessar y that 
such a disease–free status be officially appro ved, and imple menting powers to appro ve such status should 
theref ore be conferred on the Commission. 
(73)  The OIE has introduced the concep t of compar tmentalisation in the framewor k of the Terrestr ial and Aquatic 
Animal Health Codes (‘the OIE Codes’). In Union legislation adopt ed prior to this Regulation, that concept is 
recognised only for particular animal species and diseases specified in specifi c Union legislation, namely for avian 
influenza and aquatic animal diseases. This Regulation should establish the possibility of using the compar tment 
system for other animal species and diseases. In order to lay down the detailed conditions and rules for the 
recognition and appro val of compar tments and the requirements relating to them, the power to adopt acts in 
accordance with Article 290 TFEU should be delegat ed to the Commission. 
(74)  Member States should mak e their disease–free territories, zones and compar tments thereof publicly kno wn for 
the purpose of informing trading partners and facilitating trade. 
(75)  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 TFEU should be delegat ed to the Commission in respect of the criteria and 31.3.2016 L 84/10 Official Jour nal of the European Union EN     conditions for obtaining such status, the evidence needed to substantiate certificat ion of freedom from disease, 
special disease prevention and control measures, including non–vaccination status, where relevant, restr ictions, 
information to be provided, deroga tions, and conditions for the mainte nance, suspension, withdra wal or 
restoration of disease–free status. 
(76)  In order to ensure unif orm 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 compar tmentalisation and to lay down detailed rules on formats for the submission of applications 
and exchange s of information. 
(77)  The presence of an entirely non–immune population of animals, susceptible to certain liste d diseases, requires 
permanent disease awar eness 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 the availability of this effective and 
efficient tool for the control of disease emerge ncies, and that it is suffi ciently flexible to adjust to emerg ency 
situations, implementing powers should be conferr ed on the Commission to lay down necessar y rules for the 
implementation of continge ncy plans. 
(78)  Past animal health crises have shown the benefi ts of having specifi c, detailed and rapid procedures for the 
manag ement of disease emerge ncies. Those organisational procedures should ensure a rapid and effective 
response and should improve coordination of efforts on the part of all parties involved, including in particular 
the compet ent author ities and the stakeholders. They should also include cooperation with the compet ent 
author ities of neighbour ing Member States and third countr ies and territories, where feasible and relevant. 
(79)  To ensure the applicability of contingency plans in real emergency situations, it is essential to practise the systems 
concer ned and to test that they are working. To that end, the compet ent author ities of the Member States should 
carry out simulation exer cises, in cooperation with the compet ent author ities of the neighbour ing Member States 
and third countr ies and territories, where feasible and relevant. 
(80)  In order to ensure unif orm conditions for the implementation of continge ncy plans and simulation exercises, 
implementing powers should be conferr ed on the Commission to lay down rules for the practical implementation 
of those plans and exercises. 
(81)  Veterinar y 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 adop tion of this 
Regulation highlights in particular the importance of vaccines as a tool in the prevention, control and eradication 
of animal diseases. 
(82)  However , control strateg ies for some transmissible animal diseases require prohibition or restr iction of the use of 
certain veterinar y medicinal products, as their use would hampe r the effectiveness of those strategies. For 
examp le, certain veteri nary medicinal products may mask the manifestation of a disease, mak e the detection of a 
disease agent impossible or render a swif t and diffe rential diagnosis difficult and thus endange r the correct 
detection of disease. 
(83)  However , those control strateg ies may vary substantially between differ ent listed diseases. This Regulation should 
theref ore provide for rules on the use of vete rinar y medicinal products for the prevention and control of certain 
listed diseases and for harmonised criteria to be taken into consideration when deter mining 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 specifi cities of differ ent listed diseases and the availability of effective treatments, the power to 
adopt acts in accordance with Article 290 TFEU should be delega ted to the Commission in respect of the 
restr ictions on, prohibitions of or oblig ations to use certain veteri nary medicinal products within the framew ork 
of the control of certain listed diseases. In urgent cases and in order to address emerging risks with possibly 
devastating imp lications for animal or public health, the econom y, society or the environment, it should be 
possible for the measures in this regar d to be adopt ed by means of the urgency procedure. 
(84)  Follo wing the conclusions of the exper t opinion on vaccine and/or diagnostic banks for major animal diseases, 
steps should also be taken to mak e it possible for the Union and the Member States to establish reser ves of 
antig ens, vaccines and diagnostic reagents for listed diseases that represent a serious threat to animal or public 31.3.2016 L 84/11 Official Jour nal of the European Union EN     health. The establishment of a Union antigen, vaccine and diagnostic reagent bank would promote attainment of 
the Union's animal health objectives by permitting a quic k and effective response when the resources of the bank 
are required, and would represent an efficient use of limite d resources. 
(85)  In order to ensure such a quic k and effective response, the power to adopt acts in accordance with Article 290 
TFEU should be delegat ed to the Commission in respect of the establishment and manag ement of such banks , 
and safety standards and requirements for their operation. However , this Regulation should not provide for the 
adopt ion of rules on the financing of the disease prevention and control measures, including vaccination. 
(86)  Criteria for priority access to the Union antig en, vaccine and diagnostic reage nt banks ' resources should be 
established in order to ensure their effective distr ibution in emergencies. 
(87)  For reasons of secur ity in relation to bio–terror ism and agro–t errorism, certain detailed information concer ning 
the Union antig en, vaccine and diagnostic reagent banks should be treated as classified information and its 
publication should be prohibit ed. As regards the same type of information in relation to national vaccine banks, 
the constitutional requirements of differ ent Member State s as regar ds freedom of information should be respected 
while ensur ing that the information in question is treated as classified information. 
(88)  In order to ensure unif orm conditions for the management of the Union antig en, vaccine and diagnostic reagent 
banks, implementing powers should be conferred on the Commission to lay down detailed rules concer ning 
whic h biological products are to be included in those banks and for which diseases, and detailed rules on the 
supply , quantities, storage, deliver y, procedural and technical requirements for antig ens, vaccines and diagnostic 
reage nts and the frequency and content of submissions of information to the Commission. 
(89)  In the event of an outbreak of a listed disease considered to represent a high risk to animal or public health in 
the Union, Member State s should ensure that immediate disease control measures to eradicat e the disease in 
question are taken in order to prot ect animal and public health. 
(90)  The compe tent author ity should be responsible for initiating the first investig ations to conf irm or rule out an 
outbreak of a highly contagious listed disease which is considered to represent a high risk to animal or public 
health in the Union. 
(91)  The compet ent author ity should put in place preliminar y disease control measures to prevent the possible spread 
of the listed disease, and should under take an epidemiological enquir y. 
(92)  As soon as a listed disease is conf irmed, the compet ent author ity should take the necessar y disease control 
measures, if necessar y including the establishment of restr icted zones, to eradicate and prevent the further spread 
of that disease. 
(93)  The occur rence of a listed disease in wild animals may pose a risk to public health and the health of kept 
animals. Special rules should theref ore be laid down, where necessar y, for measures to control and eradicate 
diseases in wild animals. 
(94)  There may be cases where small populations of certain animals, such as rare breeds and species, may be 
endange red by standard disease control measures in the event of an occur rence of a listed disease. The protection 
of such breeds and species may require modifi ed measures to be taken by the compet ent author ity. However , 
such modif ication should not hampe r the overall control of that disease. 
(95)  For listed diseases which are not highly contagious and whic h are subject to compulsor y rules requir ing their 
eradication, the disease control measures should be implemented in such a way as to prevent the spread of the 
disease in question, in particular to non–infect ed areas. However , those measures may possibly be more limited 
than, or may be differ ent from, those applicable in relation to the most dangerous liste d diseases. This Regulation 31.3.2016 L 84/12 Official Jour nal of the European Union EN     should theref ore provide for special rules for those less dang erous diseases. Member States that have an optional 
eradication programme in place should also implement such disease control measures. In some cases, depending 
on the disease profile and the epidemiological situation, eradication may be a long-ter m objective, while the 
shor t-term aim may be to control the disease. However , the level and intensity of disease control measures should 
be propor tionate and should take into account the character istics of the listed disease in question, its distr ibution 
and its signif icance for the Member State concer ned by it and for the Union as a whole. 
(96)  In order to ensure the effective application of the disease control measures provided for in this Regulation by 
operat ors, pet keepers and compe tent author ities, 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 TFEU should be delegat ed to the Commission in respect of the detailed disease-control measures to 
be implemented in the event of suspicion or conf irmation of a listed disease in establishments, other locations 
and restr icted zones. 
(97)  In order to provide for the possibility for the Commission to adopt special disease control measures on a 
temporar y basis in the event that the disease control measures laid down in this Regulation are not suffi cient or 
appropr iate to address the risk involved, implementing powers should be conferr ed on the Commission 
concer ning the laying down of special disease control measures for a limite d period of time. 
(98)  The registration of certain transpor ters and establishments keeping terrestrial animals or handling germinal 
products or transpor ting them is necessar y in order to allow the compet ent author ity to perform adequate 
surveillance and to prevent, control and eradicat e transmissible animal diseases. 
(99)  To avoid unjustified administrative burdens and costs, Member States should be able, on a limited basis, to 
exem pt from the registration oblig ation certain types of establishments posing a low risk. Implementing powers 
should be conferr ed on the Commission in order to achi eve a harmonised approach to the granting of such 
exem ptions. Such a harmonised approach is particularly necessar y in order to prevent certain types of 
establishments from being excl uded from the registration oblig ation. This is particularly relevant not only as 
regar ds those establishments whic h pose a more than insignificant risk to animal health but also as regar ds 
establishments which pose a more than insignif icant risk to public health. An example of such risk is the keeping 
of animals that live in close contact with, or proximity to, humans, such as the breeding of dogs at a level 
involving a certain continuity of activities and a certain degree of organisation with the primar y aim of their 
being sold for the purpose of becoming pet animals in households. 
(100)  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 appro val by the compet ent author ity. 
(101)  To avoid unjustifi ed administrative burdens and costs, particularly to enterprises posing a low risk, flexibility 
should where possible be built into the relevant measures, making it possible to adapt the system of registration 
and appro val to local and regional conditions and production patter ns. 
(102)  In some cases, harmonisation of certain conditions for registration or appro val across the Union is desirable or 
necessar y. For example, germinal products establishments and assembly operations should meet certain 
conditions and should be appro ved in order to comply with intern ational standards, thereby enabling the Union 
to provide animal health guarant ees to third countr ies when trading. Such conditions should also involve 
requirements for specifi c training or profess ional qualifications for certain very specifi c establishments or 
operations (e.g. for embr yo collection teams ), or even the oblig ation for specifi c super vision by the compet ent 
author ity. The Commission should theref ore be empo wered to adopt delegat ed acts in accordance with 
Article 290 TFEU concer ning those detailed requirements, in order to provide for such specifi c conditions. 
(103)  In the interest of reducing administrative burdens, registrations and appro vals should, where possible, be 
integra ted into a registration or appro val system which the Member State concer ned may already have established 
for other purposes. 
(104)  Operato rs have first–hand kno wledge of the animals under their care. They should theref ore maintain up–t o–date 
records of information whic h is relevant for assessing the animal health status, for traceability and for an epidemi ­
ological enquir y in the event of the occur rence of a listed disease. Those records should be easily accessible to the 
compet ent author ity. 31.3.2016 L 84/13 Official Jour nal of the European Union EN     (105)  In order to ensure the availability of up–t o–date information concer ning registered establishments and operat ors 
and appro ved establishments, compet ent author ities should establish and keep a registe r of such establishments 
and operat ors. The power to adopt acts in accordance with Article 290 TFEU should be delegat ed to the 
Commission in respect of the detailed information to be included in the register of establishments and operat ors. 
(106)  In order to be appro ved by the compet ent author ity, an establishment should have to fulfil certain requirements. 
Before granting the appro val, the compet ent author ity should have to verify by means of an on–site visit whether 
all requirements have been met. In some cases, not all conditions can be met immediately , but the remaining 
deficienc ies do not present a signif icant risk to animal or public health. In such cases, it should be possible for 
the compet ent author ity to grant a conditional appro val, followed by another on–sit e visit to verify that progress 
has been made. In those cases, the compet ent author ity should provide the necessar y effective guidance to the 
operat ors of the establishments concer ned, in order that the operat or in question understands the deficiency and 
can plan for its successful resolution. 
(107)  Efficient traceability is a key element of disease control policy . Identif ication and registration requirements specific 
to the diffe rent 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 impor tant to provide for the possibility of establishing an identification and registration system for species for 
whic h such arrang ements do not exist at present, or when changing circumstances and risks so warrant. 
(108)  For certain animal species for which it is important to be able to trace individual animals or groups, a physical 
means of identif ication should be required. This entails the animal in question being physically mark ed, tagg ed, 
microc hipped or other wise identif ied by means of a method whic h can be seen or detected on or in its body and 
whic h cannot easily be remo ved. 
(109)  In order to ensure the smooth operation of the identification and registration system and to ensure traceability , 
the power to adopt acts in accordance with Article 290 TFEU should be delegat ed to the Commission in respect 
of oblig ations concer ning databases, detailed identif ication and registration requirements concer ning diffe rent 
animal species, including exemptions and conditions for such exem ptions, and documents. 
(110) It is appropr iate to reduce administrative burdens and costs and to provide for flexibility of the system in circum ­
stances where the traceability requirements can be achieved by means other than those set out in this Regulation. 
The Commission should theref ore be emp owered to adop t delegat ed acts in accordance with Article 290 TFEU 
concer ning derogat ions from the identification and registration requirements. 
(111)  In order to ensure unif orm conditions for the imple mentation of the identification and registration syste m and 
traceability , implementing powers should be confe rred on the Commission to lay down rules concer ning the 
technical specifications for databases, means of identif ication, documents and formats, and deadlines. 
(112)  An important tool for preventing the introduction and spread of a transmissible animal disease is the use of 
restr ictions on movements of animals and products that may transmit that disease. However , restr icting the 
movement of animals and products may have a severe economic imp act and may interfere with the operation of 
the internal mark et. Such restr ictions should theref ore be applied only where necessar y and propor tionate to the 
risks involved. This approach is in line with the principles laid down in the SPS Agreement and the OIE intern at­
ional standards. 
(113)  The general requirements laid down in this Regulation should apply to all animal movements, such as the 
prohibition of the movement of animals from an establishment where there are abnor mal mor talities or other 
disease symp toms with an undete rmined cause or disease prevention requirements during transpor t. 
(114)  The legal framework currently laid down in Union animal health legislation, for the movement of terrestrial 
animals and products lays down harmonised rules primar ily for such movements between Member States, while 
leav ing it up to the Member States to determine the necessar y movement requirements within their territory . A 
comparison between the current situation and an option whereby rules for movements within Member States 
would also be harmonised at Union level was set out at length in the impact assessment for the adoptio n of this 31.3.2016 L 84/14 Official Jour nal of the European Union EN     Regulation. It has been concluded that the current approac h should be maintained, as compl ete harmonisation of 
all movements would be very compl ex and the benefits in term s of the facilitation of movements between 
Member States do not outweigh the negative impact this could have on the ability to control diseases. 
(115)  For animals that are moved between Member States, a set of basic animal health requirements should apply . In 
particular , animals should not be moved from establishments with abnor mal mor talities or signs of disease of 
unkno wn cause. However , mor talities, even if abnor mal, which are linked to scientific procedures author ised 
under Directive 2010/63/EU of the European Parliament and of the Council (1) and whic h are not of infectious 
origin related to listed diseases, should not be a reason to prevent movements of animals intended for scientifi c 
purposes. 
(116)  However , this Regulation should provide for flexibility in order to facilitat e the movement of species and 
catego ries of terrestrial animals that pose a low risk in term s of spreading listed diseases between Member States. 
In addition, further possibilities for derogations should be provided for in cases where Member States or 
operat ors successfully put in place altern ative risk-mitigating measures such as high levels of biosecur ity and 
effective surveillance systems . 
(117)  Ungulates and poultr y are groups of animal species of high economic signif icance and are subject to specifi c 
movement requirements under Union legislation adopt ed prior to this Regulation, namely Council Directives 
64/432/EEC (2), 91/68/EEC (3), 2009/156/EC (4), 2009/158/EC (5) and, in part, Directive 92/65/EEC. The main 
rules governing the movement of animals of those species should be laid down in this Regulation. The detailed 
requirements which largely depend on the diseases that may be transmitt ed by different species or catego ries of 
animals should be regulated in subsequent Commission acts, taking into account the specifi cities of the diseases, 
species and catego ries of animals in question. 
(118)  As assembly operations for ungulates and poultr y pose a particularly high risk of disease, it is appropr iate to 
limit the number that can be carried out in one movement between Member States, and to lay down specifi c 
rules in this Regulation to prot ect the health of the animals involved and prevent the spread of transmissible 
animal diseases. Those assembly operations would normally take place in an establishment appro ved for that 
purpose, or, when permitted by a Member State of origin, the first assembly operation, on one means of 
transpor t such as a lorry, through the collection of animals from differ ent locations in that Member State . 
(119)  Depending on the listed diseases and listed species concer ned, it is necessar y to lay down specifi c animal health 
requirements for certain animal species other than kept ungulates and poultr y. Rules for these species were also 
laid down in the legal framew ork applicable prior to this Regulation and in particular in Directive 92/65/EEC. 
That Directive lays down specific rules for the movement of animal species including bees, bumble bees, apes, 
dogs and cats and this Regulation should theref ore provide a legal basis for the adopt ion of delegat ed and 
implementing acts laying down specifi c movement rules for those animal species. 
(120)  Confined establishments, usually used for the keeping of laborat ory animals or zoo animals, normally involve a 
high level of biosecur ity and a favourable and well-controlled health status, and are subject to fewer movements 
or to movements solely within the closed circuits of those establishments. The status of conf ined establishments, 
for which operators may apply on a voluntar y basis, was first introduced in Directive 92/65/EEC, which lays 
down rules and requirements for appro val and movement requirements for appro ved bodies, institut es and 
centres. The system thereby established enables those establishments to exchange animals amongst themselves 
with fewer movement requirements, at the same time providing health guarantees within the circuit of conf ined 
establishments. Consequently , it has been broadly accept ed by the operat ors and used as a voluntar y option. It is 
theref ore appropr iate in this Regulation to preser ve the concept of conf ined establishments and also to lay down 
rules for movement between those establishments. 31.3.2016 L 84/15 Official Jour nal of the European Union EN     
(1)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 (OJ L 276, 20.10.2010, p. 33). 
(2)Council Directive 64/432/EEC of 26 June 1964 on animal health problems affec ting intra‑Community trade in bovine animals and 
swine (OJ 121, 29.7.1964, p. 1977/64). 
(3)Council Directive 91/68/EEC of 28 Januar y 1991 on animal health conditions governing intra–Community trade in ovine and capr ine 
animals (OJ L 46, 19.2.1991, p. 19). 
(4)Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and impo rtation from 
third countr ies of equidae (OJ L 192, 23.7.2010, p. 1). 
(5)Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra‑Community trade in, and impor ts 
from third countr ies of, poultr y and hatc hing eggs (OJ L 343, 22.12.2009, p. 74). (121)  For scientifi c purposes, such as research or diagnostic purposes, and in particular for those author ised in 
accordance with Directive 2010/63/EU, it may be necessar y to move animals which do not fulfil the general 
animal health requirements laid down in this Regulation and which represent a higher animal health risk. Those 
kinds of movements should not be prohibited or unduly restr icted by this Regulation, as this could impede 
other wise author ised researc h activities and dela y scientific progress. None the less, it is essential that rules be laid 
down in this Regulation to ensure that movements of those animals take place in a safe manner . 
(122)  Movement patt erns of circus animals, animals kept in zoos, animals intende d for exhibition and certain other 
animals often deviate from the movement patt erns of other kept species. In adapting Union rules on animal 
movements specifi c consideration should be given to such animals, taking into account specific risks and 
alternative risk-mitig ation measures. 
(123)  In order to ensure that the objectives refer red to in recitals 112 to 122 of this Regulation are achieved, the power 
to adopt acts in accordance with Article 290 TFEU should be delegat ed to the Commission concer ning disease 
prevention measures in transpor t operations, specific rules for the movement of certain animal species and 
special circumstances, such as assembly operations or reject ed consignments, and special requirements or 
deroga tions for other types of movements, such as movement for scientific purposes. 
(124)  In order to ensure the possibility of applying special rules for movements where the usual movement rules are 
not sufficient or appropr iate to limit the spread of a certain disease, implementing powers should be conferr ed 
on the Commission to lay down special movement rules for a limite d period of time. 
(125)  Movements of kept terrestr ial animals between Member State s should compl y with the requirements applicable to 
such movements. In the case of animals of species which present a health risk or which are of greate r economic 
importance, they should be accompanied by an animal health certificate issued by the compet ent author ity. 
(126)  To the extent technically , practically and financia lly feasible, there should be recourse to technological 
developments in order to reduce the administrative burdens on operat ors and compet ent author ities in relation 
to certificat ion and notificati on by using information technology to replace paper documentation and to facilitat e 
notification procedures, and by using such technology as far as possible for multiple purposes. 
(127)  In cases where there is no requirement for an animal health certificate to be issued by a compet ent author ity, an 
operat or who moves animals to another Member State should issue a self–declaration document whic h conf irms 
that the animals meet the movement requirements laid down in this Regulation. 
(128)  In order to ensure that the objectives refer red to in recitals 125, 126 and 127 of this Regulation are achieved, the 
power to adopt acts in accordance with Article 290 TFEU should be delegat ed to the Commission concer ning 
rules on the content of animal health certificates, information oblig ations, derog ations from the animal health 
certification requirements, specif ic certificat ion rules, and the oblig ations of official veteri narians to conduct 
appropr iate chec ks before the signing an animal health certificate. 
(129)  Notification of movements of animals and germinal products between Member State s, and in some cases within 
the national territories of Member States, is essential in order to ensure the traceability of the animals and 
germinal products concer ned, where these movements may be linked to a risk of spreading transmissible animal 
diseases. Such movements should theref ore be notifi ed and register ed by means of an integrated comput erised 
veterinar y syste m (‘Traces’) . The Traces syste m integrates into a sing le archit ecture the comput erised syste ms 
provided for in Article 20 of Directive 90/425/EEC and in Council Decision 92/438/EEC (1) respectively , based 
on Commission Decisions 2003/24/EC (2) and 2004/292/EC (3). 31.3.2016 L 84/16 Official Jour nal of the European Union EN     
(1)Council Decision 92/438/EEC of 13 July 1992 on comput erization of veterinar y impo rt procedures (Shif t project), amending Directives 
90/675/EEC, 91/496/EEC, 91/628/EEC and Decision 90/424/EEC, and repealing Decision 88/192/EEC (OJ L 243, 25.8.1992, p. 27). 
(2)Commission Decision 2003/24/EC of 30 December 2002 concer ning the development of an integrat ed compu terised veterinar y system 
(OJ L 8, 14.1.2003, p. 44). 
(3)Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EEC 
(OJ L 94, 31.3.2004, p. 63). (130)  In order to ensure unif orm conditions for the implemen tation of the rules laid down in this Regulation on 
animal health certificat ion and movement notifi cation, implementing powers should be conferr ed on the 
Commission to lay down rules concer ning the model animal health certificates, self–declaration documents, 
formats and deadlines for movement notifi cation for both terrestr ial and aquatic animals, germinal products and, 
where also relevant, products of animal origin. 
(131)  The specific nature of movements of pet animals represents an animal health risk which deviates signif icantly 
from that of other kept animals. Specific, less stringent rules for such movements should theref ore be laid down 
in this Regulation. Such less stringent rules are only justified, however , if the pet animal genuinely accompanies 
its owner during the owner's movement, or within a limited period thereaf ter, and if no more than five pet 
animals as referred to in Part A of Annex I are moved together with their owner at one time. In order to ensure 
that pet animals do not pose a significant risk for the spread of transmissible animal diseases, and in order to 
clarify the excep tional situations in which more than five pet animals may accompan y the owner , or when the 
pet animal is to be moved within a long er time-frame before or after the owner moves, the power to adopt acts 
in accordance with Article 290 TFEU should be delegat ed to the Commission in respect of the detailed rules for 
movements of those animals. In order to ensure unif orm conditions for the implementation of the animal health 
requirements laid down in this Regulation concer ning the movements of pet animals, implementing powers 
should be conferr ed on the Commission to lay down rules concer ning the disease prevention and control 
measures to be taken for such movements. 
(132)  Wild animals may for various reasons represent an animal and public health risk, for exam ple if they are moved 
into an establishment or from one envi ronment to another environment. Appropr iate preventive measures for 
movement of those animals may need to be take n to avoid the spread of transmissible animal diseases. In order 
to ensure that wild animals do not pose a signif icant risk for the spread of transmissible animal diseases, the 
power to adopt acts in accordance with Article 290 TFEU should be delegat ed to the Commission concer ning the 
additional requirements for movements of wild terrestrial animals. 
(133)  Germinal products can represent a similar risk of spreading transmissible animal diseases to live animals. In 
addition, there are specificities in their production whic h are relat ed to high health demands for breeding animals 
and which call for stricter or particular animal health requirements concer ning the donor animals. In order to 
ensure safe movements of germinal products, to maintain their expecte d high health standard and to take into 
account certain specifi c uses of such products, the power to adopt acts in accordance with Article 290 TFEU 
should be delegat ed to the Commission concer ning the detailed requirements for movement of germinal products 
of certain animal species, special requirements applicable to, for example, their movement for scientifi c purposes, 
and derog ations from the animal health certification oblig ation. 
(134)  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 types of products, specific animal health 
measures, such as disease control and emergency measures, should be laid down in this Regulation in order 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 TFEU 
should be delegat ed to the Commission concer ning the establishment of detailed rules for movements of 
products of animal origin in relation to disease control measures take n, the obligations in respect of animal 
health certificat ion and derogat ions from those rules where the risk involved with such movements and the risk- 
mitig ation measures in place so permit. 
(135)  When Member States take national measures concer ning movements of animals and germinal products, or decide 
to take national measures to limit the impact of transmissible animal diseases other than liste d diseases within 
their territory, those national measures should not interf ere with the rules on the intern al mark et laid down in 
Union legislation. It is theref ore appropr iate to set the framew ork for such national measures and to ensure that 
they remain within the limits permitte d under Union law. 
(136)  The registration and appro val of aquaculture establishments is necessar y in order to allow the compet ent 
author ity to perf orm adequate surveillance and to prevent, control and eradicate transmissible animal diseases. 
Directive 2006/88/EC requires all establishments whic h move aquatic animals to be author ised. That system of 31.3.2016 L 84/17 Official Jour nal of the European Union EN     author isation should be maintained under this Regulation, notwithstanding the fact that, in some official 
languag es of the Union, this Regulation uses differ ent term s to refer to the author isation system from those used 
in Directive 2006/88/EC. 
(137)  The slaughte r and processing of aquaculture animals which are subject to disease control measures may spread 
transmissible animal diseases, for example as a result of the disc harge from processing establishments of effluents 
containing pathogen s. It is theref ore necessar y to appro ve processing establishments which fulfil the risk- 
mitig ation measures for such slaughter and processing operations. This Regulation should theref ore provide for 
the appro val of disease control aquatic food establishments. 
(138)  In order to ensure the availability to the public of up–to–dat e information concer ning registered and appro ved 
establishments, the compet ent author ity should establish and keep a register of such establishments. The power 
to adopt acts in accordance with Article 290 TFEU should be delega ted to the Commission concer ning the 
information to be included in register s of aquaculture establishments and the record-kee ping requirements for 
aquaculture establishments and transpor ters. 
(139)  In order to ensure unif orm conditions for the implementation of the rules laid down in this Regulation 
concer ning the registration and appro val of aquaculture establishments and disease control aquatic food 
establishments, record-kee ping and registers of establishments, implementing powers should be conferr ed on the 
Commission to lay down rules concer ning the information obligations, derogations and other implementing rules 
in that regar d. 
(140)  As it is not feasible in most cases to individually identify aquatic animals, the keepin g of records by aquaculture 
establishments, disease control aquatic food establishments and transpor ters is an essential tool in ensur ing the 
traceability of aquatic animals. Records also serve as a valuable tool for the surveillance of the health situation of 
establishments. 
(141)  As in the case of terrestrial animals, it is necessar y to lay down harmonised rules on the movement of aquatic 
animals, including rules on animal health certification and movement notificati on. 
(142)  Directive 2006/88/EC lays down rules for movements of aquatic animals whic h apply equally to movements 
within and between Member States. The key deter mining factor in relation to rules on the movement of aquatic 
animals is the health status, as regards listed diseases, of the Member State, zones and compar tments of 
destination. 
(143)  However , Directive 2006/88/EC excl udes from its scope wild aquatic animals caught or harvested for direct entr y 
into the food chain. By contrast, this Regulation retains them within its scope, but excl udes them from the 
definition of aquaculture animals. It should theref ore provide for possible measures in relation to such aquatic 
animals where, taking into account their propor tionality , such measures are justified by the risks involved. 
(144)  Consequently , the principle explained in recital 142 should also apply to movements of aquatic animals that are 
not defined as aquaculture animals but are covered by the scope of this Regulation. This applies, in particular , to 
aquatic animals with an unkno wn or confir med disease positive health status, regar dless of their final use. As 
movements of live wild aquatic animals with an unkno wn or conf irmed disease positive health status and 
intende d for human consum ption may also pose a risk of spreading listed or emerging diseases, the same system 
of rules should also apply to them. This includes those wild aquatic animals, harvested or caught for human 
consum ption, whic h are moved and temporar ily kept while awaiting slaughter . 
(145)  However , dispropor tionate movement restr ictions and unnecessar y administrative burdens for establishments and 
operat ors within the commercial fisher ies sector should be avoided. Consequently , in cases where such live wild 
aquatic animals are intended for human consum ption, the rules in question should in principle apply only to 
movements of live wild aquatic animals which pose a signif icant risk of spreading listed or emerging diseases into 31.3.2016 L 84/18 Official Jour nal of the European Union EN     Member States, zones or compar tments which have been declared free of certain listed diseases or which are 
subject to eradication programmes with regar d to those diseases. 
(146)  To encourage Member States to enhance the health status of their aquatic populations, certain adjustments and 
added flexibility should be introduced in this Regulation. 
(147)  In order to ensure control of the movement of aquatic animals, the power to adop t acts in accordance with 
Article 290 TFEU should be delegat ed to the Commission concer ning the disease prevention measures applicable 
to transpor t, specif ic rules applicable to movements of certain categor ies of aquatic animals for different 
purposes, specific requirements or derogations in respect of certain types of movements, such as movements for 
scientific purposes, and additional requirements for movements of wild aquatic animals. 
(148)  In order to ensure the possibility of temporar y derogations and specifi c requirements for movements of aquatic 
animals, where the movement rules laid down in this Regulation are not suffi cient or appropr iate to limit the 
spread of a particular listed disease, implemen ting powers should be confe rred on the Commission to lay down 
special movement rules or derogat ions for a limited period of time. 
(149) Union aquaculture production is extremely diverse as regar ds species and production systems, and this diversifi ­
cation is rapidly increasing. This may require the adoptio n at Member State level of national measures concer ning 
diseases other than those regar ded as liste d diseases in accordance with this Regulation. However , such national 
measures should be justified, necessar y and propor tionate to the goals to be achieve d. Further more, they should 
not affect movements between Member State s unless they are necessar y in order to prevent the introduction, or 
to control the spread, of disease. National measures affecting trade between Member State s should be appro ved 
and regularly reviewed at Union level. 
(150)  Currently , liste d diseases concer n animal species other than those defined by this Regulation as terrestr ial and 
aquatic species, such as reptiles, amph ibians, insects and others, only to a very limite d extent. It is theref ore not 
appropr iate to require that all the provisions of this Regulation should apply to those animal species. However , if 
a disease whic h concer ns species other than terrestrial and aquatic species should become listed, the relevant 
animal health requirements of this Regulation should apply to those species, in order to ensure that adequate and 
propor tionate disease prevention and control measures may be take n. 
(151)  In order to ensure the possibility of laying down movement rules for animals that are not defined as terrestr ial or 
aquatic animals by this Regulation, and germinal products and products of animal origin deriving from such 
animals, when a risk so warrants, the power to adopt acts in accordance with Article 290 TFEU should be 
delegat ed to the Commission concer ning the registration and appro val of establishments, record-kee ping and 
register s, identification and registration and traceability movement requirements, animal health certificat ion and 
self–declaration and movement notificati on oblig ations in respect of animals, germinal products and products of 
animal origin deriving from those species. 
(152)  Whenever necessar y in order to ensure unif orm conditions for the implementation of the animal health 
requirements for those other animal species and germinal products and products of animal origin deriving from 
them, implementing powers should be conferr ed on the Commission to lay down detailed rules concer ning those 
requirements. 
(153)  In order to prevent the introduction of listed diseases and emerging diseases into the Union, it is necessar y to 
have in place efficient rules on the entr y into the Union of animals, germinal products and products of animal 
origin that may transmit such diseases. 
(154)  In order to guarant ee the health status of the Union, this Regulation lays down provisions concer ning 
movements of animals and products within the Union. It is theref ore appropr iate, so as not to jeopardise that 
status, to impose conditions for the entr y of animals and products into the Union that are no less strict than 
those applicable to movements within the Union. 31.3.2016 L 84/19 Official Jour nal of the European Union EN     (155)  In order to ensure that animals, germinal products and products of animal origin from third countr ies or 
territories fulfil animal health requirements that provide guarantees equivalent to those provided for in Union 
legislation, it is essential that they be subject to appropr iate controls by the compet ent author ity of the third 
countr y or territory from whic h they are expor ted to the Union. Where relevant, the health status of a third 
countr y or territory of origin should be verified prior to accepti ng entr y into the Union of such animals, 
germinal products and products of animal origin. Consequently , only third countr ies and territori es which can 
demonstrate that they meet the animal health standards for entr y of the animals and products into the Union 
should be eligible to expor t them to the Union and be listed for that purpose. 
(156)  For some species and categor ies of animals, germinal products and products of animal origin, the Union lists of 
third countr ies and territories from whic h entr y into the Union is permitted have not been established in Union 
acts adopt ed prior to the date of adop tion of this Regulation. In those cases, pending the adop tion of rules 
pursuant to this Regulation, Member State s should be permitte d to determine from which countr ies and 
territories those animals, germinal products and products of animal origin may be permitted to enter their 
territory. In so deter mining, Member States should take into account the criteria laid down in this Regulation for 
the Union lists of third countr ies and territories. 
(157)  In order to ensure that the animal health requirements for entr y into the Union provided for in this Regulation 
are complied with, and that they are in line with the principles of the OIE Codes, all animals, germinal products 
and products of animal origin entering the Union should be accompan ied by an animal health certificate issued 
by the compe tent author ity of the third countr y or territory of origin conf irming that all the animal health 
requirements for entr y into the Union are complied with. However , deviation from this rule should be permitted 
in respect of commodities which pose a low animal health risk. 
(158)  Animal health certificates may stand on their own, but certificat ion is often required in Union legislation for 
other purposes, for example in order to certify that public health or animal welfare requirements of animals or 
products have been compl ied with. This has to be take n 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 legislation concer ning food and feed safety and animal welf are. 
(159)  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, transpor t containers, hay, straw , plant products, 
mate rials that may have been in contact with infected animals and equipment may also spread disease. Where 
necessar y, measures should be taken to prevent disease transmission by those means. 
(160)  In order to ensure the appropr iate level of detail for the requirements for entr y into the Union, the power to 
adopt acts in accordance with Article 290 TFEU should be delega ted to the Commission in respect of the 
adopt ion of supplementar y rules for the appro val of establishments in third countr ies and territori es and 
deroga tions, animal health requirements for the entr y into the Union of consignments from third countr ies and 
territories and animal health requirements for disease agents, other mater ials, means of transpor t and equipment 
whic h may transmit animal diseases. 
(161)  In order to ensure unif orm conditions for the implementation of animal health requirements for the entr y into 
the Union of consignments of animals, germinal products and products of animal origin, imple menting powers 
should be conferred on the Commission to lay down rules on, inter alia, the list of third countr ies and territories 
from which the entr y into the Union of animals, germinal products and products of animal origin is allowed and 
on the contents and format of model animal health certificates. 
(162)  Past exper ience has shown that when an outbreak of a serious disease occurs in Member States or in third 
countr ies or territories from which animals or products enter the Union, disease prevention and control 
measures have to be taken immediately to prevent its introduction and limit its spread. Such an emerge ncy may 31.3.2016 L 84/20 Official Jour nal of the European Union EN     involve listed diseases, emerging diseases or other animal health hazards. In that cont ext, it should be made clear 
whic h disease prevention and control measures provided for by this Regulation may be used in the event of the 
occur rence of a listed or emerging disease or hazard. In all such cases, it is essential that measures can be taken at 
very shor t notice and without any dela y. As such measures would restr ict movement within or into the Union, 
they should be implement ed at Union level whenever possible. 
(163)  In order to ensure an effective and quic k reaction to emerging risks, implementing powers should be confe rred 
on the Commission to lay down emergency measures. 
(164)  The Commission should adopt immediately applicable implementing acts in duly justified cases relating to, inter 
alia, measures regar ding emerging diseases, the stoc king, supply , stora ge, deliver y and other procedures of Union 
antig en, vaccine and diagnostic reage nt banks, the laying down of special disease control measures and 
deroga tions for a limited period of time, special rules on movements for terrestr ial and aquatic animals applying 
for a limite d period of time, emergency measures, and the listing of third countr ies and territories for the 
purposes of entr y into the Union. 
(165)  This Regulation lays down general and specifi c 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, notificati on, surveillance, registration and appro val or traceability , the Member 
States should be allowed or encourag ed 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 set out in 
this Regulation and are not inconsiste nt with the rules laid down herein, and provided that they do not hinder 
movements of animals and products between Member States, unless this is necessar y in order to prevent the 
introduction, or to control the spread, of disease. 
(166)  The national measures referred to in recital 165 should be subject to a simplified notification procedure in order 
to reduce the administrative burden. Exper ience has shown that the general notifi cation procedure laid down in 
Directive 98/34/EC of the European Parliament and of the Council (1) has been an important tool for guiding and 
improving the quality of national technical regulations — in term s of increased transparency , readability and 
effectiveness — in non–har monised or partly harmonised areas. It is theref ore appropr iate that this general 
notification procedure applies. 
(167)  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 adopt ed pursuant to them: 
Directive 64/432/EEC, Council Directive 77/391/EEC (2), Council Directive 78/52/EEC (3), Council Directive 
80/1095/EEC (4), Council Directive 82/894/EEC (5), Council Directive 88/407/EEC (6), Council Directive 
89/556/EEC (7), Council Directive 90/429/EEC (8), 31.3.2016 L 84/21 Official Jour nal of the European Union EN     
(1)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 (OJ L 204, 21.7.1998, p. 37). 
(2)Council Directive 77/391/EEC of 17 May 1977 introducing Community measures for the eradication of brucellosis, tuberculosis and 
leucosis in cattle (OJ L 145, 13.6.1977, p. 44). 
(3)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 leuk osis in cattle (OJ L 15, 19.1.1978, p. 34). 
(4)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 (OJ L 325, 1.12.1980, p. 1). 
(5)Council Directive 82/894/EEC of 21 December 1982 on the notifi cation of animal diseases within the Community (OJ L 378, 
31.12.1982, p. 58). 
(6)Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra–Community trade in and 
impo rts of semen of domestic animals of the bovine species (OJ L 194, 22.7.1988, p. 10). 
(7)Council Directive 89/556/EEC of 25 Sept ember 1989 on animal health conditions governing intra–Community trade in and 
impo rtation from third countr ies of embr yos of domestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1). 
(8)Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra–Community trade in and 
impo rts of semen of domestic animals of the porcine species (OJ L 224, 18.8.1990, p. 62). Directive 91/68/EEC, Council Decision 91/666/EEC (1), Council Directive 92/35/EEC (2), Directive 92/65/EEC, 
Council Directive 92/66/EEC (3), Council Directive 92/118/EEC (4), Council Directive 92/119/EEC (5), Council 
Decision 95/410/EC (6), Council Directive 2000/75/EC (7), Council Decision 2000/258/EC (8), Council Directive 
2001/89/EC (9), 
Council Directive 2002/60/EC (10), Council Directive 2002/99/EC (11), Council Directive 2003/85/EC (12), Council 
Regulation (EC) No 21/2004 (13), Council Directive 2004/68/EC (14), Council Directive 2005/94/EC (15), Directive 
2006/88/EC, Council Directive 2008/71/EC (16), Directive 2009/156/EC, Directive 2009/158/EC, Regulation (EU) 
No 576/2013 of the European Parliament and of the Council (17). 
(168)  This Regulation provides for the rules on the identif ication and registration of bovine animals while rules for beef 
labelling remain outside of its scope. Regulation (EC) No 1760/2000 of the European Parliament and of the 
Council (18) provides for the rules on the identif ication and registration of bovine animals and for the rules on 
beef labelling. It should thus be amended to repeal its provisions on the identif ication and registration of bovine 
animals while those concer ning beef labelling would have to remain in force. 
(169)  With a view to guaranteeing the reliability of the arrange ments provided for in existing Regulations establishing 
system s for the identif ication and registration of bovine, ovine and capr ine animals, that legislation requires the 
Member States to carry out adequat e and efficient control measures. Such adequate and efficient official control 
measures should also be preser ved in the future. As part of the ‘Smar ter rules for safer food’ packag e of 
proposals, this Regulation does not envisage provisions on official controls since those rules should be provided 
for in the framewor k of the proposed horizontal legislation on official controls. However , even if the proposed 
new horizontal rules on official controls were not to enter into force at the same time as this Regulation, the 31.3.2016 L 84/22 Official Jour nal of the European Union EN     
(1)Council Decision 91/666/ EEC of 11 December 1991 establishing Community reser ves of foot–and–mouth disease vaccines (OJ L 368, 
31.12.1991, p. 21). 
(2)Council Directive 92/35/EEC of 29 Apr il 1992 laying down control rules and measures to combat African horse sickness (OJ L 157, 
10.6.1992, p. 19). 
(3)Council Directive 92/66/EEC of 14 July 1992 introducing Community measures for the control of Newcastle disease (OJ L 260, 
5.9.1992, p. 1). 
(4)Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and 
impo rts 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 (OJ L 62, 15.3.1993, p. 49). 
(5)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 (OJ L 62, 15.3.1993, p. 69). 
(6)Council Decision 95/410/EC of 22 June 1995 laying down the rules for the microbiological testing by sampling in the establishment of 
origin of poultr y for slaught er intended for Finland and Sweden (OJ L 243, 11.10.1995, p. 25). 
(7)Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control and eradication of bluetongue 
(OJ L 327, 22.12.2000, p. 74). 
(8)Council Decision 2000/258/EC of 20 March 2000 designating a specific institute responsible for establishing the criteria necessar y for 
standardising the serological tests to monit or the effectiveness of rabies vaccines (OJ L 79, 30.3.2000, p. 40). 
(9)Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (OJ L 316, 
1.12.2001, p. 5). 
(10)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 regar ds Teschen disease and African swine fever (OJ L 192, 20.7.2002, p. 27). 
(11)Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, 
distr ibution and introduction of products of animal origin for human consump tion (OJ L 18, 23.1.2003, p. 11). 
(12)Council Directive 2003/85/EC of 29 of Sept ember 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 (OJ L 306, 22.11.2003, p. 1). 
(13)Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identif ication and registration of ovine and 
capr ine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC (OJ L 5, 9.1.2004, p. 8). 
(14)Council Directive 2004/68/EC of 26 Apr il 2004 laying down animal health rules for the impor tation into and transit through the 
Community of certain live ungulat e animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC 
(OJ L 139, 30.4.2004, p. 321). 
(15)Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing 
Directive 92/40/EEC (OJ L 10, 14.1.2006, p. 16). 
(16)Council Directive 2008/71/EC of 15 July 2008 on the identif ication and registration of pigs (OJ L 213, 8.8.2008, p. 31). 
(17)Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non–commercial movement of 
pet animals and repealing Regulation (EC) No 998/2003 (OJ L 178, 28.6.2013, p. 1). 
(18)Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identifi ­
cation and registration of bovine animals and regar ding the labelling of beef and beef products and repealing Council Regulation (EC) 
No 820/97 (OJ L 204, 11.8.2000, p. 1). existing horizontal rules on official controls would allow the Commission to ensure an equivalent level of 
control. 
(170)  The rules laid down in the legislative acts referred to in recital 167 are to be replaced by this Regulation and by 
subsequent Commission acts to be adopt ed pursuant to this Regulation. According ly, those legislative acts should 
be repealed. However , to ensure lega l clarity and avoid a legal vacuum, the repeal should in the first place take 
effect only when the relevant delegat ed and implementing acts are adopt ed pursuant to this Regulation. It is 
theref ore necessar y to empo wer the Commission to determine the date s when the repeal of those legislative acts 
is to take effect, while the legislator should set a deadline. 
(171)  The following Council acts in the area of animal health are obsolete and should be expressly repealed in the 
inter ests of clarity of Union legislation: Council Decision 78/642/EEC (1), Council Directive 79/110/EEC (2), 
Council Directive 81/6/EEC (3), Council Decision 89/455/EEC (4), Council Directive 90/423/EEC (5), Council 
Decision 90/678/EEC (6), Council Directive 92/36/EEC (7), Council Directive 98/99/EC (8). 
(172)  The requirements set out in this Regulation should not apply until the key delegat ed and implementing acts have 
been adopt ed by the Commission pursuant to this Regulation, allowing a period of 24 months from the adoptio n 
of the key acts until the date when they start to apply , thus permitting Member State s and operat ors to duly 
adap t to the new rules. In addition, it is appropr iate to provide for a period of at least 36 months for the 
Commission to elaborat e the new rules. 
(173)  In order to ensure legal certainty as regards the application of rules for the identif ication and registration of 
animals and disease control measures for certain animal diseases and zoonoses, the power to adopt acts in 
accordance with Article 290 TFEU should be delegat ed to the Commission in respect of the date on whic h 
Regulation (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 are to cease to apply , whilst a deadline in that regard should be set in this 
Regulation. 
(174)  In line with the preventive approach to animal health that is promote d by this Regulation, the special measures 
concer ning salmonella that applied to live animals dispatch ed to Finland and Sweden prior to 20 Apr il 2016 
should continue to apply and Regulation (EC) No 2160/2003 should be amended according ly. 
(175)  Consider ing the recent adopt ion of Regulation (EU) No 576/2013, it is desirable to allow for a long transitional 
period before the corresponding rules set out in this Regulation start to apply . 
(176)  The imple menting powers provided for in this Regulation should be exer cised in accordance with Regulation (EU) 
No 182/2011 of the European Parliament and of the Council (9). 31.3.2016 L 84/23 Official Jour nal of the European Union EN     
(1)Council Decision 78/642/EEC of 25 July 1978 on health protection measures in respect of the Republic of Botswana (OJ L 213, 
3.8.1978, p. 15). 
(2)Council Directive 79/110/EEC of 24 Januar y 1979 author izing the Italian Republic to postpone the notifi cation and implem entation of 
its national plans for the accelerated eradication of brucellosis and tuberculosis in cattle (OJ L 29, 3.2.1979, p. 24). 
(3)Council Directive 81/6/EEC of 1 Januar y 1981 author izing the Hellenic Republic to communicate and to implement its national plans 
for the accelerated eradication of brucellosis and tuberculosis in cattle (OJ L 14, 16.1.1981, p. 22). 
(4)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 (OJ L 223, 2.8.1989, p. 19). 
(5)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, Directive 64/432/EEC on animal health problems affecting intra- Community trade in bovine animals and 
swine and Directive 72/462/EEC on health and veterinar y inspection problems upon impor tation of bovine animals and swine and fresh 
meat or meat products from third countr ies (OJ L 224, 18.8.1990, p. 13). 
(6)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 (OJ L 373, 31.12.1990, p. 29). 
(7)Council Directive 92/36/EEC of 29 Apr il 1992 amending, with regar d to African horse sickness, Directive 90/426/EEC on animal health 
conditions governing the movement and impo rt from third countr ies of equidae (OJ L 157, 10.6.1992, p. 28). 
(8)Council Directive 98/99/EC of 14 December 1998 amending Directive 97/12/EC amending and updating Directive 64/432/EEC on 
health problems affecting intra–Community trade in bovine animals and swine (OJ L 358, 31.12.1998, p. 107). 
(9)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general 
principles concer ning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 
28.2.2011, p. 13). (177)  It is of particular importance that the Commission carry out appropr iate consultations during its preparat ory 
work, including at exper t level. The Commission, when prepar ing and drawing up delega ted acts, should ensure a 
simultaneous, timely and appropr iate transmission of relevant documents to the European Parliament and to the 
Council. 
(178)  This Regulation should not creat e a dispropor tionate 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 derogat ion from the 
requirements of this Regulation for such enterprises has not been considered, in view of the public policy 
objectives of prote cting animal health and public health. However , a number of derogations for such enterprises 
should be provided for in relation to the diffe rent requirements of this Regulation, taking into account the risks 
involved. 
(179)  Since 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 mat erial that may be involved in the spread of transmissible 
animal diseases, cannot be sufficiently achi eved by the Member State s but can rather be better achi eved at Union 
level through a common and coordinated legal framework for animal health, the Union may adopt measures, in 
accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty on European Union. In 
accordance with the principle of propor tionality as set out in that Article, this Regulation does not go beyond 
what is necessar y in order to achieve those objectives, 
HAVE ADOPTED THIS REGUL ATION: 
PART I 
GENERAL RULES 
CHAPTER 1 
Subject matter , aim, scope and definitions 
Article 1 
Subject matter and aim 
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 categor isation of diseases of Union concer n and for the establishment of responsibilities for 
animal health (Par t I: Articles 1 to 17); 
(b)  the early detection, notification and repor ting of diseases, surveillance, eradication programmes and disease–free 
status (Par t II: Articles 18 to 42); 
(c)  disease aware ness, preparedness and control (Par t III: Articles 43 to 83); 
(d)  the registration and appro val of establishments and transpor ters, movements and traceability of animals, germinal 
products and products of animal origin within the Union (Par t IV: Articles 84 to 228; and Part VI: Articles 244 
to 248 and 252 to 256); 
(e)  the entr y of animals, germinal products, and products of animal origin into the Union and the expor t of such 
consignments from the Union (Part V: Articles 229 to 243; and Part VI: Articles 244 to 246 and 252 to 256); 
(f)  non–commercial movements of pet animals into a Member State from another Member State or from a third 
countr y or territory , (Part VI: Articles 244 to 256); 
(g)  the emerge ncy measures to be take n in the event of a disease emergency situation (Par t VII: Articles 257 to 262). 31.3.2016 L 84/24 Official Jour nal of the European Union EN     2. The rules refer red to in paragraph 1: 
(a)  aim to ensure: 
(i)  improved animal health to suppor t sustainable agricultural and aquaculture production in the Union; 
(ii)  the effective functioning of the internal market ; 
(iii)  a reduction in the adverse effects on animal health, public health and the envi ronment of: 
—  certain diseases; 
—  the measures take n to prevent and control diseases; 
(b)  take into account: 
(i)  the relationship between animal health and: 
—  public health; 
—  the envi ronment, including biodiversity and valuable genetic resources, as well as the impact of climat e 
change ; 
—  food and feed safety ; 
—  animal welf are, including the spar ing of any avoidable pain, distress or suffering; 
—  antimicrobial resistance; 
—  food secur ity; 
(ii)  the economic, social, cultural and environmental consequences arising from the application of disease control 
and prevention measures; 
(iii)  relevant intern ational standards. 
Article 2 
Scope 
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 transpor t, equipment and all other paths of infec tion and mater ial involved or poten tially 
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 1082/2013/EU; 
(b)  Regulation (EC) No 999/2001; 
(c)  Directive 2003/99/EC; 
(d)  Regulation (EC) No 2160/2003. 31.3.2016 L 84/25 Official Jour nal of the European Union EN     Article 3 
Scope of Parts IV, V and VI 
1. Title I of Part IV (Articles 84 to 171) shall apply to: 
(a)  terrestrial animals, and animals which are not terrestr ial 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 (Articles 172 to 226) shall apply to: 
(a)  aquatic animals, and animals whic h 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 (Articles 227 and 228) shall apply to: 
(a)  other animals; 
(b)  germinal products and products of animal origin from the other animals refer red to in point (a). 
4. Parts IV and V shall not apply to non–commercial movements of pet animals as refer red to in paragraph 6 of this 
Article or to non–commercial movements of pet animals within a Member State. 
5. Movements of pet animals, other than non–commercial movements, shall comply with the animal health 
requirements laid down in Parts IV and V. 
The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning the adaptations which are 
necessar y in order to ensure that Parts IV and V are correctly applied to pet animals, in particular to take account of the 
fact that pet animals are kept in households by pet keepe rs. 
6. Part VI shall only apply to non–commercial movements of pet animals that compl y with the requirements laid 
down in Articles 245 and 246 as regards the maximum number of animals that may accompan y their owner and the 
maximum number of days elapsing between the movement of the owner and the movement of the animal. 
Article 4 
Def initions 
For the purposes of this Regulation, the following definit ions apply:  
(1) ‘animals’ means vertebr ate and invertebrate animals;  
(2) ‘terrestr ial animals’ means birds, terrestrial mammals, bees and bumble bees;  
(3) ‘aquatic animals’ means animals of the following species, at all life stages, including eggs, sper m and gam etes: 
(a)  fish belonging to the superclass Agnatha and to the classes Chondr ichthy es, Sarcopter ygii and Actinopte rygii; 
(b)  aquatic molluscs belonging to the phylum Mollusca; 
(c)  aquatic crustaceans belonging to the subphylum Crustacea;  
(4) ‘other animals’ means animals of species other than those falling within the definition of terrestrial or aquatic 
animals; 31.3.2016 L 84/26 Official Jour nal of the European Union EN     (5) ‘kept animals’ means animals which are kept by humans, including, in the case of aquatic animals, aquaculture 
animals;  
(6) ‘aquaculture’ means the keeping of aquatic animals where the animals remain the proper ty of one or more natural 
or legal persons throughout the rear ing or culture stages , up to and including harvesting, excl uding the harvesting 
or catchi ng for the purposes of human consump tion of wild aquatic animals which are subsequently temporar ily 
kept while awaitin g slaughter without being fed;  
(7) ‘aquaculture animals’ means any aquatic animals subject to aquaculture,  
(8) ‘wild animals’ means animals which are not kept animals;  
(9) ‘poultr y’ means birds that are reared or kept in captivity for: 
(a)  the production of: 
(i)  meat ; 
(ii)  eggs for consump tion; 
(iii)  other products; 
(b)  restocking supplies of game birds; 
(c)  the purpose of breeding of birds used for the types of production refer red to in points (a) and (b);  
(10) ‘cap tive birds’ means any birds other than poultr y that are kept in captivi ty for any reason other than those 
referred to in point (9), including those that are kept for shows, races, exhibitions, compet itions, breeding or 
selling;  
(11) ‘pet animal’ means a kept animal of the species listed in Annex I which is kept for private non–commercial 
purposes;  
(12) ‘pet keeper ’ means a natural person, and may include a pet owner , keep ing a pet animal;  
(13) ‘pet owner ’ means a natural person indicated as the owner in the identification document refer red to in point (c) of 
Article 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2);  
(14) ‘non–commercial movement ’ means any movement of a pet animal accompan ying its owner and which 
(a)  does not have as its aim either the sale of or another form of transfer of ownership of the pet animal 
concer ned; and 
(b)  is part of the movement of the pet owner: 
(i)  either under his direct responsibility ; or 
(ii)  under the responsibility of an author ised person, in cases where the pet animal is physically separated from 
the pet owner ;  
(15) ‘author ised person’ means any natural person who has author isation in writing from the pet owner to carry out 
the non–commercial movement of the pet animal on behalf of the pet owner;  
(16) ‘disease’ means the occur rence of infections and infestations in animals, with or without clinical or pathological 
manifes tations, caused by one or more disease agents;  
(17) ‘disease agent’ means a pathogen transmissible to animals or to humans whic h is capable of causing a disease in 
animals;  
(18) ‘liste d diseases’ means diseases liste d in accordance with Article 5(1);  
(19) ‘disease prof ile’ means the criteria of a disease refer red to in point (a) of Article 7; 31.3.2016 L 84/27 Official Jour nal of the European Union EN     (20) ‘liste d species’ means an animal species or group of animal species listed in accordance with Article 8(2), or, in the 
case of emerging diseases, an animal species or group of animal species whic h meets the criteria for listed species 
laid down in Article 8(2);  
(21) ‘hazard’ means a disease agent in, or a condition of, an animal or product with the poten tial to have an adverse 
effect on the health of humans or animals;  
(22) ‘risk’ means the likelihood of the occur rence and the likely magnitude of the biological and economic 
consequences of an adverse effect on animal or public health;  
(23) ‘biosecur ity’ means the sum of manage ment 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, compar tment, means of transpor t or any other facilities, premises or location;  
(24) ‘operat or’ means any natural or legal person having animals or products under his responsibility , including for a 
limite d duration of time, but excluding pet keepers and veterinar ians;  
(25) ‘transpor ter’ means an operat or transpor ting animals on his own account or on account of a third party;  
(26) ‘animal professiona l’ means a natural or legal person having an occupational relationship with animals or products, 
other than operat ors or veterinar ians;  
(27) ‘establishment’ means any premises, structure, or, in the case of open-air farming, any environment or place, where 
animals or germinal products are kept, on a temporar y or permanent basis, excep t for: 
(a)  households where pet animals are kept; 
(b)  veterinar y practices or clinics;  
(28) ‘germinal products’ means: 
(a)  semen, oocyte s and embr yos intended for artificial reproduction; 
(b)  hatch ing eggs;  
(29) ‘products of animal origin’ means: 
(a)  food of animal origin, including honey and blood; 
(b)  live bivalve molluscs, live echinode rms, live tunicate s and live mar ine gastropods, intended for human 
consum ption; and 
(c)  animals other than those referred to in point (b) intended to be prepared with a view to being supplied live to 
the final consumer;  
(30) ‘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 consump tion, excluding germinal products;  
(31) ‘derived products’ means products obtained from one or more treatments, transf ormations or steps in the 
processing of animal by–products;  
(32) ‘products’ means: 
(a)  germinal products; 
(b)  products of animal origin; 
(c)  animal by–products and derived products; 31.3.2016 L 84/28 Official Jour nal of the European Union EN     (33) ‘official control’ means any form of control carried out by a compet ent author ity for the purpose of verifying 
compl iance with this Regulation;  
(34) ‘health status’ means the disease status as regards the liste d diseases relevant for a particular listed species with 
respect to: 
(a)  an animal; 
(b)  animals within: 
(i)  an epidemiological unit ; 
(ii)  an establishment ; 
(iii)  a zone; 
(iv)  a compar tment ; 
(v)  a Member State; 
(vi)  a third countr y or territory ;  
(35) ‘zone’ means: 
(a)  for terrestr ial animals, an area of a Member State, third countr y or territory with a precise geographical 
delimitation, containing an animal subpopulation with a distinct health status with respect to a specific disease 
or specifi c diseases subject to appropr iate surveillance, disease control and biosecur ity measures; 
(b)  for aquatic animals, a contiguous hydrological system with a distinct health status with respect to a specifi c 
disease or specifi c diseases that forms an area that is refer red to in one of the following: 
(i)  an entire water catchment from the source of a water way to the estuar y or lake; 
(ii)  more than one water catch ment ; 
(iii)  part of a water catchment from the source of a wate rway 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 estuar y with a precise geographical delimitation;  
(36) ‘wat er catchm ent’ means an area or basin of land bounded by natural features such as hills or mountains, into 
whic h all run–off water flows;  
(37) ‘com partment’ 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 biosecur ity manag ement system with a 
distinct health status with respect to a specifi c disease or specifi c diseases subject to appropr iate surveillance, 
disease control and biosecur ity measures;  
(38) ‘quarantine’ means the keeping of animals in isolation with no direct or indirect contact with animals outside the 
epidemiological unit, for the purpose of ensur ing that there is no spread of one or more specif ied diseases while 
the animals in isolation are undergoing obser vation for a specifi ed length of time and, if appropr iate, testing and 
treatment ;  
(39) ‘epidemiological unit ’ means a group of animals with the same likelihood of exposure to a disease agent;  
(40) ‘outbreak’ means the officiall y conf irmed occur rence of a listed disease or an emerging disease in one or more 
animals in an establishment or other place where animals are kept or locat ed;  
(41) ‘restr icted zone’ means a zone in which restr ictions 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 restr ictions are applied; a restr icted zone may, when relevant, include protection and surveillance zones; 31.3.2016 L 84/29 Official Jour nal of the European Union EN     (42) ‘protect ion zone’ means a zone around and including the location of an outbreak , where disease control measures 
are applied in order to prevent the spread of the disease from that zone;  
(43) ‘surveillance zone’ means a zone whic h is established around the protection zone, and where disease control 
measures are applied in order to prevent the spread of the disease from the protection zone;  
(44) ‘hatc hing eggs’ means eggs, laid by poultr y or captive birds, intended for incubation;  
(45) ‘ungulat es’ means the animals listed in Annex III;  
(46) ‘germinal product establishment’ means: 
(a)  in relation to semen, an establishment where semen is collect ed, produced, processed or store d; 
(b)  in relation to oocyte s and embr yos, a group of profes sionals or structure super vised by a team veterinar ian 
compet ent to perf orm the collection, production, processing and storage of oocytes and embr yos; 
(c)  in relation to hatc hing eggs, a hatche ry;  
(47) ‘hatc hery’ means an establishment whic h collects, stores, incubates and hatch es eggs for the supply of: 
(a)  hatch ing eggs; 
(b)  day–old chic ks or hatch lings of other species;  
(48) ‘confined establishment’ means any permanent, geographically limited establishment, created on a voluntar y basis 
and appro ved for the purpose of movements, where the animals are: 
(a)  kept or bred for the purposes of exhibitions, education, the conser vation of species or research; 
(b)  confined and separated from the surrounding environment ; and 
(c)  subject to animal health surveillance and biosecur ity measures;  
(49) ‘assembly operation’ means the assembling of kept terrestr ial animals from more than one establishment for a 
period shor ter than the required residency period for the species of animals concer ned;  
(50) ‘residency period’ means the minimum period necessar y in order to ensure that an animal whic h has been 
introduced into an establishment is not of a lower health status than that of the animals in that establishment ;  
(51) ‘Traces’ means the integrat ed comput erised vete rinar y syste m with a sing le architecture provided for in Decisions 
2003/24/EC and 2004/292/EC;  
(52) ‘disease control aquatic food establishment’ means a food business appro ved in accordance with Article 179;  
(53) ‘official veter inar ian’ means a veteri narian author ised by the compet ent author ity and appropr iately qualified to 
perf orm official activities in accordance with this Regulation;  
(54) ‘official vete rinar ian in a third countr y or territory ’ means a veterinar ian in a third countr y or territory 
corresponding to an official veterinar ian as referred to in point (53);  
(55) ‘com petent author ity’ means the central vete rinar y author ity of a Member State responsible for the organisation of 
official controls and any other official activities in accordance with this Regulation or any other author ity to which 
that responsibility has been delega ted;  
(56) ‘com petent author ity of a third countr y or territory’ means the author ity in a third countr y or territory 
corresponding to the compet ent author ities refer red to in point (55). 31.3.2016 L 84/30 Official Jour nal of the European Union EN     CHAPTER 2 
Listed diseases and emerging diseases and listed species 
Article 5 
Listing of diseases 
1. The disease-specif ic rules for the prevention and control of diseases provided for in this Regulation shall apply to: 
(a)  the following listed diseases: 
(i)  foot and mouth disease; 
(ii)  classical swine fever; 
(iii)  African swine fever; 
(iv)  highly pathogen ic avian influenza; 
(v)  African horse sickness ; and 
(b)  the liste d diseases set out in the list in Annex II. 
2. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning amendments to the list 
referred to in point (b) of paragraph 1 of this Article. 
3. A disease shall be included on the list referred to in point (b) of paragraph 1 of this Article if it has been assessed 
in accordance with Article 7 and it meets: 
(a)  all of the following criteria: 
(i)  scientific evidence indicates that the disease is transmissible; 
(ii)  animal species are either suscep tible to the disease or vect ors and reser voirs thereof exist in the Union; 
(iii)  the disease causes negative effects on animal health or poses a risk to public health due to its zoonotic 
charact er; 
(iv)  diagnostic tools are available for the disease; and 
(v)  risk-mitig ating measures and, where relevant, surveillance of the disease are effective and propor tionate to the 
risks posed by the disease in the Union; and 
(b)  at least one of the following criteria: 
(i)  the disease causes or could cause signif icant negative effects in the Union on animal health, or poses or could 
pose a signif icant risk to public health due to its zoonotic charact er; 
(ii)  the disease agent has developed resistance to treatments whic h poses a signif icant dange r to public and/or 
animal health in the Union; 
(iii)  the disease causes or could cause a significant negative economic impact affecting agriculture or aquaculture 
production in the Union; 
(iv)  the disease has the poten tial to generat e a crisis or the disease agent could be used for the purpose of 
biot errorism; or 
(v)  the disease has or could have a signif icant negative impact on the environment, including biodiversity , of the 
Union. 
4. The Commission shall adopt deleg ated acts in accordance with Article 264 concer ning the remo val of a disease 
from the list refer red to in point (b) of paragraph 1 of this Article when that disease no longer fulfils the criteria 
provided for in paragraph 3 of this Article. 31.3.2016 L 84/31 Official Jour nal of the European Union EN     5. The Commission shall review the listing of each disease in the light of newly available significant scientific data. 
Article 6 
Emerging diseases 
1. The rules for the prevention and control of diseases shall apply to emerging diseases as provided for in this 
Regulation. 
2. A disease other than a listed disease shall be considered to be an emerging disease (‘emerging disease’) provided it 
has the potential to meet the criteria for listing diseases provided for in Article 5(3) and: 
(a)  results from the evolution or chang e of an existing disease agent ; 
(b)  is a kno wn disease spreading to a new geographic area, species or population; 
(c)  is diagnosed for the first time in the Union; or 
(d)  is caused by an unrecognised or a previously unrecognised disease agent. 
3. The Commission shall, by means of implementing acts, take the necessar y measures regar ding an emerging disease 
whic h fulfils the criteria set out in paragraph 2 of this Article. Those implementing acts shall be adopt ed in accordance 
with the examination procedure refer red to in Article 266(2). 
4. On duly justif ied imperative grounds of urgency relating to a disease representing an emerging risk having a highly 
signif icant impa ct, the Commission shall adopt immediately applicable implementing acts in accordance with the 
procedure refer red to in Article 266(3). 
5. Any obligation on operat ors in respect of an emerging disease, as set out in this Regulation, shall only apply if the 
Commission has adopt ed an implementing act for that disease in accordance with paragraph 3 of this Article or if the 
disease is covered by a contingency plan in accordance with Article 43. 
Article 7 
Assessment parameters for the listing of diseases 
The Commission shall use the following assessment parameter s in order to deter mine whether a disease meets the 
conditions requir ing it to be liste d in accordance with Article 5(2): 
(a)  the disease prof ile, whic h shall compr ise the following: 
(i)  the animal species concer ned by the disease; 
(ii)  the morbidity and mor tality rates of the disease in animal populations; 
(iii)  the zoonotic character of the disease; 
(iv)  the resistance to treatments, including antimicrobial resistance; 
(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 distr ibution 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; 31.3.2016 L 84/32 Official Jour nal of the European Union EN     (b)  the impact of the disease on: 
(i)  agricultural and aquaculture production and other parts of the econom y, as regar ds: 
—  the level of presence of the disease in the Union; 
—  the loss of production due to the disease; 
—  other losses; 
(ii)  human health, as regar ds: 
—  transmissibility between animals and humans; 
—  transmissibility between humans; 
—  the sever ity of human forms of the disease; 
—  the availability of effective prevention or medical treatment in humans; 
(iii)  animal welfare; 
(iv)  biodiversity and the environment ; 
(c)  its poten tial to generat e a crisis situation and its poten tial use in biote rrorism; 
(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)  biosecur ity measures; 
(v)  restr ictions on the movement of animals and products; 
(vi)  killing of animals; 
(vii)  disposal of carcasses and other relevant animal by–produc ts; 
(e)  the impact of disease prevention and control measures, as regards: 
(i)  the direct and indirect costs for the affected sectors and the econom y as a whole; 
(ii)  their societal acceptance; 
(iii)  the welf are of affected subpopulations of kept and wild animals; 
(iv)  the environment and biodiversity . 
Article 8 
Listing of species 
1. The disease-specific rules for listed diseases provided for in this Regulation and the rules adopt ed pursuant to this 
Regulation shall apply to listed species. 
2. The Commission shall, by means of imp lementing acts, establish a list of species as referred to in paragraph 1 of 
this Article that fulfil the criteria set out in paragraph 3 of this Article. Those implementing acts shall be adopt ed in 
accordance with the examination procedure referred to in Article 266(2). 
That list shall compr ise those animal species, or groups of animal species which pose a considerable risk for the spread 
of specifi c listed diseases, based on the following criteria: 
(a)  the susceptibility of the animal population at risk; 31.3.2016 L 84/33 Official Jour nal of the European Union EN     (b)  the duration of the incubation period and infective period for the animals concer ned; 
(c)  the capability of those animals to carry those specific diseases. 
3. Animal species or groups of animal species shall be added to the list if they are affected or if they pose a risk for 
the spread of a specif ic listed disease because: 
(a)  they are suscep tible to a specifi c listed disease or scientific evidence indicates that such susceptibi lity is likely ; or 
(b)  they are vect or species or reser voirs for that disease, or scientific evidence indicates that such role is likely. 
4. The Commission shall, by means of implementing acts, remo ve animal species or groups of animal species from 
the list when: 
(a)  the relevant listed disease in relation to whic h the animal species or group of animal species concer ned has been 
liste d has been remo ved from the list of diseases; or 
(b)  scientific evidence indicates that the species or group of species concer ned no longer fulfils the criteria set out in 
paragraph 3. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 9 
Disease prev ention and control rules to be applied to different categor ies of listed diseases 
1. Disease prevention and control rules shall apply to liste d diseases as follows: 
(a)  As regards listed diseases that do not normally occur in the Union and for whic h immediate eradication measures 
must be taken as soon as they are detect ed, the following rules shall apply , as relevant : 
(i)  the rules for disease awar eness and preparedness provided for in Title I of Part III (Articles 43 to 52); 
(ii)  the disease control measures provided for in Chapt er 1 of Title II of Part III (Articles 53 to 71); and 
(iii)  the rules for compar tmentalisation provided for in Article 37(1). 
For those liste d diseases, the measures refer red to in point (b), as appropr iate, as well as points (d) and (e), shall also 
apply , as relevant. 
(b)  As regar ds liste d diseases whic h must be controlled in all Member States with the goal of eradicating them 
throughout the Union, the following rules shall apply , as relevant: 
(i)  the rules for compul sory eradication programmes provided for in Article 31(1); 
(ii)  the rules for disease–free Member State s and zones provided for in Article 36; 
(iii)  the rules for compar tmentalisation provided for in Article 37(2); and 
(iv)  the disease control measures provided for in Articles 72 to 75, Articles 77 to 79 and Articles 81 and 83. 
For those listed diseases, the measures refer red to in points (d) and (e) shall also apply , as relevant. 
(c)  As regar ds listed diseases whic h are of relevance to some Member States and for which measures are needed to 
prevent them from spreading to parts of the Union that are officially disease-free or that have eradication 
programmes for the liste d disease concer ned, the following rules shall apply , as relevant : 
(i)  the rules for optional eradication provided for in Article 31(2); 
(ii)  the rules for disease–free Member State s and zones provided for in Article 36; 31.3.2016 L 84/34 Official Jour nal of the European Union EN     (iii)  the rules for compar tmentalisation provided for in Article 37(2); and 
(iv)  the rules for disease control measures provided for in Articles 76, 77, 78, 80, 82 and 83. 
For those listed diseases, the measures refer red to in points (d) and (e) shall also apply , as relevant. 
(d)  As regards listed diseases for whic h measures are needed to prevent them from spreading on account of their entr y 
into the Union or movements between Member States, the following rules shall apply , as relevant: 
(i)  the rules for movement within the Union provided for in Chapt ers 3 to 6 of Title I (Articles 124 to 169), 
Chapt ers 2 and 3 of Title II of Part IV (Articles 191 to 225) and Chapt ers 2 and 3 of Part VI (Articles 247 
to 251); and 
(ii)  the rules for entr y into the Union and expor t from the Union provided for in Part V (Articles 229 to 243). 
The liste d diseases refer red to in points (a), (b) and (c) shall also be considered as listed diseases under this point, as 
well as those refer red to in point (e), where the risk posed by the disease in question can be effectively and propor ­
tionately mitig ated by measures concer ning movements of animals and products. 
(e)  As regards listed diseases for which there is a need for surveillance within the Union, the following rules shall apply , 
as relevant: 
(i)  the rules for notificati on and repor ting provided for in Chapt er 1 of Part II (Articles 18 to 23); and 
(ii)  the rules for surveillance provided for in Chapt er 2 of Part II (Articles 24 to 30). 
The listed diseases refer red to in points (a), (b) and (c) shall also be considered as liste d diseases under this point. 
2. The Commission shall, by means of implementing acts, determine the application of the disease prevention and 
control rules refer red to in paragraph 1 to the respective listed diseases on the basis of the criteria set out in Annex IV, 
also in the light of newly available signif icant scientifi c data. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
3. The Commission shall, by means of implementing acts, modify the application of the disease prevention and 
control rules refer red to in paragraph 2 to the respective listed diseases when the disease in question no long er fulfils the 
criteria laid down in the relevant Section of Annex IV, also in the light of newly available signif icant scientific data. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
4. On duly justif ied imperative grounds of urgency relating to a listed disease representing an emerging risk having a 
highly signif icant impact, the Commission shall adop t immediate ly applicable implementing acts in accordance with the 
procedure refer red to in Article 266(3). 
CHAPTER 3 
Responsibilities for animal health 
Section 1 
Operators, animal prof essionals and pet keep ers 
Article 10 
Responsibilities for animal health and biosecur ity measures 
1. Operato rs shall: 
(a)  as rega rds kept animals and products under their responsibility , be responsible for: 
(i)  the health of kept animals; 31.3.2016 L 84/35 Official Jour nal of the European Union EN     (ii) prudent and responsible use of veteri nary medicines, without prejudice to the role and responsibility of veterina ­
rians, 
(iii)  minimising the risk of the spread of diseases; 
(iv)  good animal husbandr y; 
(b)  where appropr iate, take such biosecur ity measures regar ding kept animals, and products under their responsibility , 
as are appropr iate for: 
(i)  the species and catego ries of kept animals and products; 
(ii)  the type of production; and 
(iii)  the risks involved, taking into account : 
—  geographical location and climatic conditions; and 
—  local circumstances and practices; 
(c)  where appropr iate, take biosecur ity measures regarding wild animals. 
2. Animal professionals shall take action to minimise the risk of the spread of diseases in the cont ext of their 
occupational relationship with animals and products. 
3. Point (a) of paragraph 1 shall also apply to pet keepers. 
4. The biosecur ity measures refer red to in point (b) of paragraph 1 shall be implement ed, as appropr iate, through: 
(a)  physical prot ection measures, whic h may include: 
(i)  enclosing, fencing, roofing, netting, as appropr iate; 
(ii)  cleaning, disinf ection and control of insects and rodents; 
(iii)  in the case of aquatic animals, where appropr iate: 
—  measures concer ning the water supply and disc harge; 
—  natural or artificial barriers to surrounding water courses that prevent aquatic animals from entering or 
leav ing the establishment concer ned, including measures against flooding or infiltration of water from 
surrounding water courses; 
(b)  manage ment measures, which may include: 
(i)  procedures for entering and exiting the establishment for animals, products, vehicles and persons; 
(ii)  procedures for using equipment ; 
(iii)  conditions for movement based on the risks involved; 
(iv)  conditions for introducing animals or products into the establishment ; 
(v)  quarantine, isolation or separation of newly introduced or sick animals; 
(vi)  a system for safe disposal of dead animals and other animal by–products. 
5. Operato rs, animal professionals and pet keepers shall cooperate with the compet ent author ity and veteri narians in 
the application of the disease prevention and control measures provided for in this Regulation. 
6. The Commission may, by means of implementing acts, lay down minimum requirements necessar y for the 
unif orm application of this Article. 31.3.2016 L 84/36 Official Jour nal of the European Union EN     Such implementing acts shall reflect the matte rs refer red to in point (b) of paragraph 1. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 11 
Kno wledge of animal health 
1. Operato rs and animal professionals shall have adequate kno wledge of: 
(a)  animal diseases, including those that are transmissible to humans; 
(b)  biosecur ity principles; 
(c)  the intera ction between animal health, animal welf are and human health; 
(d)  good practice of animal husbandr y for the animal species under their care; 
(e)  resistance to treatments, including antimicrobial resistance, and its implications. 
2. The content and the level of kno wledge required in accordance with paragraph 1 shall depend on: 
(a) the species and categor ies of kept animals or products under the responsibility of the operat ors and animal profes ­
sionals concer ned and the nature of their occupational relationship with those animals or products; 
(b)  the type of production; 
(c)  the tasks performed. 
3. The kno wledge provided for in paragraph 1 shall be acquired in one of the following ways: 
(a)  professional exper ience or training; 
(b)  existing programmes in agricultural or aquaculture sector s that are relevant for animal health; 
(c)  formal education; 
(d)  other exper ience or other training whic h results in the same level of kno wledge as that covered by points (a), (b) 
or (c). 
4. Operato rs selling or other wise transferr ing the ownership of future pet animals shall provide basic information to 
the future pet keeper , regar ding the matters referred to in paragraph 1, as relevant for the pet animal in question. 
Section 2 
Veter inar ians and aquatic animal health prof essionals 
Article 12 
Responsibilities of veter inar ians and aquatic animal health professionals 
1. Veterinar ians shall in the course of their activities which fall within the scope of this Regulation: 
(a)  take all appropr iate measures to prevent the introduction, development and spread of diseases; 
(b)  take action to ensure the early detec tion of diseases by carrying out proper diagnosis and differential diagnosis to 
rule out or conf irm a disease; 31.3.2016 L 84/37 Official Jour nal of the European Union EN     (c)  play an active role in: 
(i)  raising animal health awar eness, and awar eness of the inter action between animal health, animal welfare and 
human health; 
(ii)  disease prevention; 
(iii)  the early detection of, and rapid response to, diseases. 
(iv)  raising aware ness of resistance to treatments, including antimicrobial resistance, and its implicati ons; 
(d)  cooperate with the compet ent author ity, operators, animal profe ssionals and pet keepers in the application of the 
disease prevention and control measures provided for in this Regulation. 
2. Aquatic animal health professionals may under take activities assigned to veterinar ians under this Regulation in 
relation to aquatic animals provided that they are author ised to do so by the Member State concer ned under national 
law. In that event, paragraph 1 shall apply to those aquatic animal health professionals. 
3. Veterinar ians and aquatic animal health professionals shall maintain and develop their professional capacities 
relat ed to their areas of activities whic h fall within the scope of this Regulation. 
Section 3 
Member Sta tes 
Article 13 
Member States' responsibilities 
1. In order to ensure that the compe tent author ity for animal health has the capability to take the necessar y and 
appropr iate measures, and to carry out the activities, required by this Regulation, each Member State shall, at the 
appropr iate administrative level, ensure that compet ent author ity has: 
(a)  qualifi ed personnel, facilities, equipment, financia l resources and an effective organisation covering the whole 
territory of the Member State; 
(b)  access to laborat ories with the qualified personnel, facilities, equipment and financial resources needed to ensure the 
rapid and accurate diagnosis and differ ential diagnosis of liste d diseases and emerging diseases; 
(c)  suffi ciently trained veteri narians involved in performin g the activities referred to in Article 12. 
2. Member State s shall encourage operat ors and animal professionals to acquire, maintain and develop the adequate 
kno wledge of animal health provided for in Article 11 through relevant programmes in agricultural or aquaculture 
sector s or formal education. 
Article 14 
Delegation by a competent author ity of official activities 
1. The compet ent author ity may delegat e one or more of the following activities to veterinar ians other than official 
veterinar ians: 
(a)  practical application of measures under the eradication programmes provided for in Article 32; 
(b)  suppor ting the compet ent author ity in carrying out surveillance as provided for in Article 26 or in relation to 
surveillance programmes as provided for in Article 28; 31.3.2016 L 84/38 Official Jour nal of the European Union EN     (c)  activities relat ed to: 
(i)  disease awar eness, preparedness and control as provided for in Part III, concer ning: 
—  sam pling activities and implementation of inve stigations and epidemiological enquir ies within the 
framew ork of Article 54, points (b) to (g) of Article 55(1), and Articles 57, 73, 74, 79 and 80 in the event 
of the suspect ed presence of a disease, and any implementing and delegat ed acts adopt ed pursuant to those 
Articles; 
—  carrying out activities relating to disease control measures in the event of an outbreak of disease, as regar ds 
activities listed in Article 61, points (a), (b), (e), (f) and (i) of Article 65(1), Article 70(1), Articles 79 and 80, 
and Article 81(1) and (2), and any implementing and delegat ed acts adop ted pursuant to those Articles; 
—  carrying out emergency vaccination in accordance with Article 69; 
(ii)  registration, appro val, traceability and movements as provided for in Part IV; 
(iii)  issuing and completing the identification documents for pet animals as provided for in point (c) of Article 247, 
point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2); 
(iv)  the application and use of means of identification as referred to in point (a)(ii) of Article 252(1). 
2. Member States may provide for natural or legal persons to be author ised to perform activities refer red to in 
points (a), (b) and (c)(i), (ii) and (iv) of paragraph 1 for specifi cally identified task s for which those persons have 
suffi cient specifi c kno wledge. In that event, paragraph 1 of this Article and the responsibilities laid down in Article 12 
shall apply to those persons. 
3. The Commission shall be empo wered to adop t delegat ed acts in accordance with Article 264 concer ning other 
activities which may be delegat ed to veteri narians in addition to those provided for in paragraph 1, and, as appropr iate, 
to prescr ibe the necessar y circumstances and conditions for such delegatio n. 
The Commission shall take account of the nature of those activities and of relevant intern ational standards when 
adoptin g those delegat ed acts. 
Article 15 
Public informa tion 
Where there are reasonable grounds to suspect that animals or products originating from within the Union or entering 
from outside the Union may present a risk, the compet ent author ity shall take appropr iate steps to inform the public of 
the nature of the risk and the measures which are take n or about to be take n to prevent or control that risk, taking into 
account the nature, seriousness and exte nt of that risk and the public interest in being informed. 
Section 4 
Laborator ies, facilities and other natural and legal persons handling disease 
agents, vaccines and other biological products 
Article 16 
Obligations of laborat ories, 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 any 
relevant intern ational standards: 
(a)  take appropr iate biosecur ity, biosaf ety 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 those 
purposes; 31.3.2016 L 84/39 Official Jour nal of the European Union EN     (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 delegat ed acts in accordance with Article 264 concer ning the safet y 
measures for the prevention and control of listed and emerging diseases as regards laboratori es, facilities and other 
natural or lega l persons handling the disease agents, vaccines and other biological products in relation to: 
(a)  biosecur ity, biosaf ety and bio–containment measures; 
(b)  movement requirements for disease agents, vaccines and other biological products. 
Article 17 
Animal health laborato ries 
1. Official laboratori es for animal health, consisting of Union reference laboratori es, national reference laborat ories 
and official animal health laboratori es, shall, in fulfilling their tasks and responsibilities, cooperat e within a network of 
Union animal health laboratories. 
2. The laboratories referred to in paragraph 1 shall cooperat e under the coordination of the Union reference 
laborat ories, to ensure that the surveillance, notifi cation and repor ting of diseases, eradication programmes, the 
definit ion of disease–free status, and the movements of animals and products within the Union, their entr y into the 
Union and expor ts to third countr ies or territories provided for in this Regulation, are based on state–of–the–ar t, solid 
and reliable laboratory analyses, tests and diagnoses. 
3. The results and repor ts provided by the official laborat ories shall be subject to the principles of professional 
secrecy and confidentiality and the duty of notification to the compet ent author ity whic h designat ed them, irrespective 
of the natural or legal person who request ed the laboratory analyses, tests or diagnoses. 
4. In the event that an official laboratory in one Member State conducts diagnostic analyses on samples from animals 
originating in another Member State, that official laboratory shall notify the compet ent author ity of the Member State 
from whic h the sample s originated: 
(a)  immediately of any results indicating the suspicion or detection of a liste d disease as refer red to in point (a) of 
Article 9(1); 
(b)  without undue dela y of any results indicating the suspicion or detection of a liste d disease as referred to in point (e) 
of Article 9(1) other than those refer red to in point (a) of Article 9(1). 
PART II 
DISEASE NOTIFIC ATION AND REPORTING, SUR VEILL ANCE, ERADIC ATION PROGRAMMES, 
DISEASE–FREE STATUS 
CHAPTER 1 
Disease notification and repor ting 
Article 18 
Notif ication within Member States 
1. Member States shall ensure that operators and other relevant natural or legal persons: 
(a)  immediately notify the compet ent author ity where there are any reasons to suspect the presence in animals of a 
liste d disease as refer red to in point (a) of Article 9(1), or where the presence of such a disease is detec ted in animals; 31.3.2016 L 84/40 Official Jour nal of the European Union EN     (b)  as soon as practicable notify the compe tent author ity where there are any reasons to suspect the presence in animals 
of a listed disease as referred to in point (e) of Article 9(1) other than those referred to in point (a) of Article 9(1), or 
where the presence of such a disease is detect ed in animals; 
(c)  notify a veteri narian of abnor mal mor talities and other signs of serious disease or signif icant decreased production 
rates with an undeterm ined cause, for further investig ation, including sampling for laboratory examination when the 
situation so requires. 
2. Member States may decide that the notifi cations provided for in point (c) of paragraph 1 may be direct ed to the 
compet ent author ity. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  criteria to determine whether the circumstances requir ing notifi cation descr ibed in point (c) of paragraph 1 occur; 
(b)  detailed rules for the further investigation provided for in point (c) of paragraph 1. 
Article 19 
Union notif ication 
1. Member States shall immediate ly notify the Commission and the other Member States of any outbreaks of listed 
diseases as refer red to in point (e) of Article 9(1) for which an immediate notifi cation is required in order to ensure the 
timely imp lementation of necessar y risk manag ement measures, taking into account the disease profile. 
2. The notifi cation provided for in paragraph 1 shall contain the following information on the outbreak: 
(a)  the disease agent and, where relevant, the subtype; 
(b)  the relevant dates, in particular those of the suspicion and the confir mation of the outbreak; 
(c)  the type and location of the outbreak; 
(d)  any relat ed outbreak s; 
(e)  the animals involved in the outbreak; 
(f)  any disease control measures take n in relation to the outbreak; 
(g)  the possible or kno wn origin of the liste d disease; 
(h)  the diagnostic methods used. 
Article 20 
Union repor ting 
1. Member States shall repor t to the Commission and to the other Member States the information on listed diseases 
referred to in in point (e) of Article 9(1) for which: 
(a)  immediate notifi cation of an outbreak is not required under Article 19(1); 
(b)  immediate notifi cation of an outbreak is required under Article 19(1), but additional information is required to be 
repor ted to the Commission and the other Member States on: 
(i)  surveillance in accordance with the rules laid down in an implementing act adopt ed in accordance with 
Article 30; 
(ii)  an eradication programme in accordance with the rules laid down in an implementing act adopt ed in accordance 
with Article 35. 31.3.2016 L 84/41 Official Jour nal of the European Union EN     2. The repor ts provided for in paragraph 1 shall include information on: 
(a)  the detec tion of the listed diseases refer red to in paragraph 1; 
(b)  the results of surveillance when required in accordance with rules adopt ed in accordance with point (d)(ii) of 
Article 29 or point (b)(ii) of Article 30(1); 
(c)  the results of surveillance programmes when required in accordance with Article 28(3) and rules adopt ed in 
accordance with point (d)(ii) of Article 29 or point (b)(ii) of Article 30(1); 
(d)  eradication programmes when required in accordance with Article 34 and rules laid down in an implementing act 
adopt ed in accordance with Article 35. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
provisions supplementing the requirements of paragraph 2 and repor ting on other matters concer ning surveillance and 
eradication programmes where necessar y in order to ensure an efficient application of the disease prevention rules and 
control rules laid down in this Regulation. 
Article 21 
Notif ication and repor ting regions 
The Member States shall establish notification and repor ting regions for the purpose of the notificati on and repor ting 
provided for in Articles 19 and 20. 
Article 22 
Computer ised informa tion system for Union notif ication and Union repor ting of diseases 
The Commission shall set up and manage a comput erised information system for the operation of the mech anisms and 
tools for the notification and repor ting requirements provided for in Articles 19, 20 and 21. 
Article 23 
Implementing powers concer ning Union notif ication and Union repor ting and the computer ised 
information system 
The Commission shall, by means of implementing acts, lay down rules for the notificati on and repor ting requirements 
and the comput erised information syste m provided for in Articles 19 to 22 with respect to: 
(a)  those listed diseases refer red to in point (e) of Article 9(1) whic h are to be subject to immediate notification by the 
Member States as well as the necessar y measures relating to the notificati on, in accordance with Article 19; 
(b)  the information to be provided by the Member States in the repor ting provided for in Article 20; 
(c)  procedures for the establishment and use of the comput erised information system provided for in Article 22 and 
transitional measures for the migration of the data and the information from existing systems into the new system 
and its full operability ; 
(d)  the format and structure of the data to be entered into the comput erised information system provided for in 
Article 22; 
(e)  the deadlines and frequencies of the notification and repor ting provided for in Articles 19 and 20, whic h shall be 
done at times and frequencies whic h ensure transparency and the timely application of the necessar y risk 
manage ment measures, based on the disease prof ile and the type of outbreak . 
(f)  the listing of notification and repor ting regions provided for in Article 21. 31.3.2016 L 84/42 Official Jour nal of the European Union EN     Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 2 
Surveillance 
Article 24 
Operators' surveillance obligation 
For the purpose of detecting the presence of listed diseases and emerging diseases, operators shall: 
(a)  obser ve the health and behaviour of animals under their responsibility ; 
(b)  obser ve any chang es in the normal production parameter s 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 abnor mal mor talities and other signs of serious disease in animals under their responsibility . 
Article 25 
Animal health visits 
1. Operato rs shall ensure that establishments under their responsibility receive animal health visits from a 
veterinar ian when appropr iate due to the risks posed by the establishment in question, taking into account: 
(a)  the type of establishment ; 
(b)  the species and categor ies of kept animals on the establishment ; 
(c)  the epidemiological situation in the zone or region as regards liste d and emerging diseases to which the animals in 
the establishment are susceptible; 
(d)  any other relevant surveillance, or official controls to whic h the kept animals and type of establishment are subject. 
Such animal health visits shall take place at frequencies that are propor tionat e to the risks posed by the establishment 
concer ned. 
They may be combined with visits for other purposes. 
2. The animal health visits provided for in paragraph 1 shall be made for the purpose of disease prevention, in 
particular through: 
(a)  the provision of advice to the operator concer ned on biosecur ity and other animal health matt ers, as relevant for the 
type of establishment and the species and catego ries of kept animals on the establishment. 
(b)  the detec tion of, and information on, signs indicative of the occur rence of liste d diseases or emerging diseases; 
3. The Commission may, by means of implementing acts, lay down minimum requirements necessar y for the 
unif orm application of this Article. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 26 
The competent author ity's surveillance obligation 
1. The compe tent author ity shall conduct surveillance to detect the presence of listed diseases as refer red to in 
point (e) of Article 9(1) and relevant emerging diseases. 31.3.2016 L 84/43 Official Jour nal of the European Union EN     2. The surveillance shall be designed in such a way as to ensure the timely detection of the presence of the listed 
diseases refer red to in point (e) of Article 9(1) and emerging diseases by means of the collection, collation and analysis 
of relevant information relating to the disease situation. 
3. The compet ent author ity shall, whenever possible and appropr iate, make use of the results of the surveillance 
conduct ed by operat ors and the information obtained through animal health visits in accordance with Articles 24 
and 25, respectively . 
4. The compet ent author ity shall ensure that surveillance meets the requirements provided for in Article 27 and in 
any rules adopt ed pursuant to point (a) of Article 29. 
5. The compet ent author ity shall ensure that the information obtained through the surveillance provided for in 
paragraph 1 is collect ed and used in an effective and efficient manner . 
Article 27 
Methodology , frequency and intensity of surveillance 
The design, means, diagnostic methods, frequency , intensi ty, targe ted animal population, and sampling patter ns of the 
surveillance provided for in Article 26 shall be appropr iate and propor tionate to the objectives of the surveillance, 
taking into account : 
(a)  the disease prof ile; 
(b)  the risk factors involved; 
(c)  the health status in: 
(i)  the Member State , zone or compar tment thereof subject to the surveillance; 
(ii)  the Member States and third countr ies or territori es which either border on, or from whic h animals and 
products enter into, that Member State, zone or compar tment thereof; 
(d)  surveillance conduct ed by operat ors in accordance with Article 24, including animal health visits as refer red to in 
Article 25, or by other public author ities. 
Article 28 
Union surveillance prog rammes 
1. The compet ent author ity shall under take surveillance as provided for in Article 26(1) within the framew ork of a 
surveillance programme when a disease is relevant for the Union in accordance with point (c) of Article 29. 
2. Member States establishing a surveillance programme in accordance with paragraph 1 shall submit it to the 
Commission. 
3. Member States implementing a surveillance programme in accordance with paragraph 1 shall submit regular 
repor ts on the results of the implementation of that programme to the Commission. 
Article 29 
Delegation of powers 
The Commission shall be empo wered to adopt delega ted acts in accordance with Article 264 concer ning: 
(a)  the design, means, diagnostic methods, frequency , intensity , targe ted animal population, and sampling patte rns of 
the surveillance provided for in Article 27; 31.3.2016 L 84/44 Official Jour nal of the European Union EN     (b)  the criteria for the official conf irmation and case definitions of listed diseases as referred to in point (e) of 
Article 9(1), and, where relevant, of emerging diseases; 
(c)  the criteria used to establish the relevance of a disease which is to be subject to a surveillance programme relevant 
for the Union for the purposes of point (a) of Article 30(1), taking into account the disease profile and the risk 
factors involved; 
(d)  requirements for surveillance programmes as provided for in Article 28(1) regarding: 
(i)  the conte nts of surveillance programmes; 
(ii)  the information to be included in the submission of surveillance programmes in accordance with Article 28(2) 
and regular repor ts in accordance with Article 28(3); 
(iii)  the period of application of surveillance programmes. 
Article 30 
Implementing powers 
1. The Commission shall, by means of imple menting acts, lay down requirements concer ning surveillance and 
surveillance programmes as provided for in Articles 26 and 28 and in the rules adopt ed pursuant to Article 29, as 
regar ds: 
(a)  establishing whic h of the listed diseases refer red to in point (e) of Article 9(1) are to be subject to surveillance 
programmes in accordance with Article 28, including the geographical scope of such programmes; 
(b)  the format and procedure for: 
(i)  the submission of those surveillance programmes for information to the Commission and other Member States; 
(ii)  the repor ting to the Commission on the results of the surveillance. 
2. The Commission may, by means of implementing acts, lay down the criteria to be used for evaluating the 
surveillance programmes refer red to in Article 28. 
3. The implementing acts refer red to in paragraphs 1 and 2 of this Article shall be adop ted in accordance with the 
examination procedure refer red to in Article 266(2). 
CHAPTER 3 
Eradication programmes 
Article 31 
Compulsor y and optional eradication prog rammes 
1. Member States which are not free, or not kno wn to be free, from one or more of the liste d diseases refer red to in 
point (b) of Article 9(1) throughout their territory, or in zones or compar tments thereof, shall: 
(a)  establish a programme for the eradication of, or demonstration of freedom from, that liste d disease, to be carried 
out in the animal populations concer ned by that disease and covering the relevant parts of their territory or the 
relevant zones or compar tments thereof (‘compulsory eradication programme’), to apply until the conditions for the 
grant of disease–free status in the territory of the Member State or zone concer ned, as provided for in Article 36(1), 
or compar tment, as provided for in Article 37(2), are fulfilled; 
(b)  submit the draf t compulsor y eradication programme to the Commission for appro val. 31.3.2016 L 84/45 Official Jour nal of the European Union EN     2. Member States which are not free, or not kno wn to be free, from one or more of the liste d diseases refer red to in 
point (c) of Article 9(1) and which decide to establish a programme for the eradication of that listed disease, to be 
carried out in the animal populations concer ned by the disease in question and covering the relevant parts of their 
territory or zones or compar tments thereof (‘optional eradication programme’), shall submit a draf t of that programme 
to the Commission for appro val, where the Member State concer ned asks for the recognition, within the Union, of 
animal health guarantees as regards the disease in question for movements of animals or products. 
Such an optional eradication programme shall apply until: 
(a)  the conditions for the grant of disease–free status in the territory of the Member State or zone concer ned, as 
provided for in Article 36(1), or compar tment, as provided for in Article 37(2), are fulfilled; or 
(b)  it is established that the conditions for the grant of disease–free status cannot be achieved and that the programme 
no longer fulfils its purpose; or 
(c)  the Member State concer ned withdra ws the programme. 
3. The Commission shall, by means of implemen ting acts, appro ve: 
(a)  draf t compul sory eradication programmes submitted to it for appro val in accordance with paragraph 1; 
(b)  draf t optional eradication programmes submitt ed to it for appro val in accordance with paragraph 2, 
if the conditions set out in this Chapt er are met. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
4. On duly justified imperative grounds of urgency relating to a liste d disease representing a risk having a highly 
signif icant impact, the Commission shall adop t immediate ly applicable implementing acts provided for in point (a) of 
paragraph 3 of this Article in accordance with the procedure referred to in Article 266(3). 
The Commission may, for duly justified reasons, by means of implementing acts, appro ve an amendment proposed by 
the Member State concer ned or withdraw the appro val of eradication programmes appro ved in accordance with 
points (a) and (b) of paragraph 3 of this Article. Those implementing acts shall be adop ted in accordance with the 
examination procedure refer red to in Article 266(2). 
5. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the disease control strateg ies, interm ediate and final targets for specifi c diseases, and period of application of 
eradication programmes; 
(b)  derogations from the requirement for the submission of eradication programmes for appro val, as provided for in 
point (b) of paragraph 1 of this Article and in paragraph 2 thereof, where such appro val is not necessar y due to the 
adoptio n of rules regarding those programmes in accordance with Articles 32(2) and 35; 
(c)  the information to be provided by Member States to the Commission and to the other Member States concer ning 
derogations from the requirement for appro val of eradication programmes as provided for in point (b) of this 
paragraph. 
The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 amending or discontinuing 
rules adop ted pursuant to point (b) of this paragraph. 
Article 32 
Measures under compulsor y and optional eradication prog rammes 
1. Eradication programmes shall consist of at least the following measures: 
(a)  disease control measures for the eradication of the disease agent from establishments, compar tments and zones in 
which a disease occurs and to prevent re–infection; 31.3.2016 L 84/46 Official Jour nal of the European Union EN     (b)  surveillance to be carried out in accordance with the rules laid down in Articles 26 to 30 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 adopt delega ted acts in accordance with Article 264 concer ning the following elements to 
ensure the effectiveness of eradication programmes: 
(a)  disease control measures as provided for in point (a) of paragraph 1; 
(b)  disease control measures to be taken to avoid re–infect ion of the target ed animal population with the disease in 
question in establishments, zones and compar tments; 
(c)  surveillance design, means, diagnostic methods, frequency , intensity , target ed animal population and sam pling 
patter ns; 
(d)  disease control measures to be taken in the event of positive surveillance results for the listed disease as provided for 
in point (c) of paragraph 1; 
(e)  criteria for vaccination, where relevant and appropr iate for the disease or species in question. 
Article 33 
Content of compulsor y and optional eradication prog rammes submitted for appro val to the 
Commission 
Member States shall include the following information in applications for appro val of compul sory and optional 
eradication programmes submitte d to the Commission in accordance with Article 31(1) and (2): 
(a)  a descr iption of the epidemiological situation of the listed disease covered by the compulsor y or optional eradication 
programme in question; 
(b)  a descr iption and demarcation of the geographical and administrative area or the compar tment covered by the 
eradication programme; 
(c)  a descr iption of the disease control measures of the eradication programme as provided for in Article 32(1) and in 
the rules adopt ed pursuant to Article 32(2); 
(d)  a descr iption of the organisati on, super vision and roles of the parties involved in the eradication programme; 
(e)  the estimated duration of the eradication programme; 
(f)  the interm ediate targets of, and the disease control strategies for imple menting, the eradication programme. 
Article 34 
Repor ting 
Member States implementing eradication programmes shall submit to the Commission: 
(a)  repor ts enabling the Commission to monitor achieve ment of the interm ediate targets of the on-going eradication 
programmes as refer red to in point (f) of Article 33; 
(b)  a final repor t after completion of the eradication programme in question. 31.3.2016 L 84/47 Official Jour nal of the European Union EN     Article 35 
Implementing powers 
The Commission shall, by means of implementing acts, lay down rules concer ning the information, format and 
procedural requirements provided for in Articles 31 to 34 as regar ds: 
(a)  the submission of draf t compulsor y and draf t optional eradication programmes for appro val; 
(b)  performa nce indicators ; 
(c)  repor ting to the Commission and other Member States on the results of the implementation of compulsor y or 
optional eradication programmes. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 4 
Disease–fr ee status 
Article 36 
Disease–free Member States and zones 
1. A Member State may apply to the Commission for appro val of disease–free status for one or more of the listed 
diseases referred to in points (b) and (c) of Article 9(1), for one or more of the relevant animal species, 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 anywhe re in the 
territory of the Member State concer ned or in the relevant zone or zones covered by the application; 
(b)  the disease agent is kno wn not to be able to survive in the entire territory of the Member State, or in the relevant 
zone or zones covered by the application, according to the criteria refer red to in point (a)(ii) of Article 39; 
(c)  in the case of listed diseases only transmitted by vect ors, none of the vect ors are present, or they are kno wn not to 
be able to survive in the entire territory of the Member State , or in the relevant zone or zones covered by the 
application, according to the criteria refer red to in point (a)(ii) of Article 39; 
(d)  freedom from the listed disease has been demonstrated by: 
(i)  an eradication programme compl ying with the rules laid down in Article 32(1) and rules adopt ed pursuant to 
paragraph 2 of that Article; or 
(ii)  histor ical and surveillance data. 
2. Applications by Member States for disease–free status shall include evidence demonstrating that the conditions for 
disease–free status laid down in paragraph 1 are fulfilled. 
3. A Member State may in certain specific cases apply to the Commission for appro val of disease–free status for one 
or more of the liste d diseases refer red to in point (a) of Article 9(1), and in particular for appro val of non–vaccination 
status for the entire territory , or for one or more zones thereof, provided that the following conditions are fulfilled : 
(a)  freedom from the listed disease has been demonstrated by: 
(i)  an eradication programme compl ying with the rules laid down in Article 32(1) and rules adopt ed pursuant to 
paragraph 2 of that Article; or 
(ii)  histor ical and surveillance data; 31.3.2016 L 84/48 Official Jour nal of the European Union EN     (b)  it has been demonstrated that vaccination against the disease would lead to costs which would exceed those 
resulting from maintaining freedom from disease without vaccination. 
4. The Commission shall, by means of implementing acts, appro ve, subject to amendments where necessar y, 
applications by Member States for disease–free status or non-vaccination status when the conditions referred to in 
paragraphs 1 and 2 and, as relevant, paragraph 3 are fulfilled. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 37 
Compar tments 
1. A Member State may apply to the Commission for recognition of the disease–free status of compar tments for 
listed diseases refer red to in point (a) of Article 9(1), and for the protection of the disease–free status of such a 
compar tment in the event of an outbreak 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 the application can be effectively prevent ed at 
compar tment level, taking into account the disease prof ile; 
(b)  the compar tment covered by the application is subject to a sing le common biosecur ity manag ement system designed 
to ensure the disease–free status of all establishments forming part of it; and 
(c)  the compar tment covered by the application has been appro ved by the compet ent author ity for the purposes of 
movements of animals and products thereof in accordance with: 
(i)  Articles 99 and 100 for compar tments keeping terrestrial animals and products thereof; 
(ii)  Articles 183 and 184 for compar tments keeping aquaculture animals and products thereof. 
2. A Member State may apply to the Commission for recognition of the disease–free status of compar tments for one 
or more of the listed diseases refer red to in points (b) and (c) of Article 9(1), provided that: 
(a)  the introduction of the listed disease or listed diseases covered by the application can be effectively prevent ed at 
compar tment level, taking into account the disease prof ile; 
(b)  one or more of the following conditions are compl ied with: 
(i)  the conditions laid down in Article 36(1) are fulfilled; 
(ii)  the establishments of the compar tment covered by the application have started or resumed their activities and 
have established a common biosecur ity manag ement system designed to ensure the freedom from disease of that 
compar tment ; 
(c)  the compar tment covered by the application is subject to a sing le common biosecur ity manag ement system designed 
to ensure the disease–free status of all establishments forming part of it; and 
(d)  the compar tment covered by the application has been appro ved by the compet ent author ity for the purposes of 
movements of animals and products thereof in accordance with: 
(i)  Articles 99 and 100 for compar tments keeping terrestrial animals and products thereof; 
(ii)  Articles 183 and 184 for compar tments keeping aquaculture animals and products thereof. 
3. Applications by Member States for recognition of the disease–free status of compar tments in accordance with 
paragraphs 1 and 2 shall include evidence demonstrating that the conditions laid down in those paragraphs are fulfilled. 31.3.2016 L 84/49 Official Jour nal of the European Union EN     4. The Commission shall, by means of implemen ting acts: 
(a)  recognise, subject to amendments where necessar y, the disease–free status of compar tments, when the conditions 
laid down in paragraph 1 or paragraph 2 and in paragraph 3 are fulfilled; 
(b)  determi ne for whic h of the listed diseases referred to in points (a), (b) and (c) of Article 9(1) the disease–free 
compar tments may be established. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
5. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
provisions supplementing those contained in this Article, on: 
(a)  the requirements for recognition of the disease-free status of compar tments as provided for in paragraphs 1 and 2 of 
this Article, based on the prof ile of the liste d diseases referred to in points (a), (b) and (c) of Article 9(1), concer ning 
at least: 
(i)  surveillance results and other evidence needed to substantiate freedom from disease; 
(ii)  biosecur ity measures; 
(b)  the detailed rules for the appro val by the compet ent author ity of the disease–free status of compar tments as 
provided for in paragraphs 1 and 2; and 
(c)  rules concer ning compar tments which are locat ed in the territory of more than one Member State. 
Article 38 
Lists of disease–free Member States, zones or compar tments 
Each Member State shall establish and maintain an up-to -date list of its territory or zones with disease–free status as 
provided for in Article 36(1) and (3), and of its compar tments with disease-free status, as provided for in Article 37(1) 
and (2), when applicable. 
Member States shall make those lists publicly available. The Commission shall assist the Member State s in making the 
information contained in those lists available to the public by providing on its internet page the link s to the internet– 
based information page s of the Member States. 
Article 39 
Delegation of powers concer ning the disease–free status of Member States and zones 
The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  detailed rules for the disease–free status of Member States and zones thereof, based on the diffe rent disease prof iles, 
concer ning: 
(i)  the criteria to be used to substantiate claims by Member States that no liste d species are present or able to 
survive in their territory and the evidence required to substantiate such claims, as provided for in point (a) of 
Article 36(1); 
(ii)  the criteria to be used, and the evidence required, to substantiate claims that a disease agent or vector is not 
able to survive, as provided for in points (b) and (c) of Article 36(1); 
(iii)  the criteria to be used, and the conditions to be applied, to deter mine freedom from the disease in question, as 
refer red to in point (d) of Article 36(1); 31.3.2016 L 84/50 Official Jour nal of the European Union EN     (iv)  surveillance results and other evidence needed to substantiate freedom from disease; 
(v)  biosecur ity measures; 
(vi)  restr ictions and conditions for vaccination in disease-free Member States and zones thereof; 
(vii)  the establishment of zones separating disease–free zones or zones under the eradication programme from 
restr icted zones (‘buff er zones ’); 
(viii)  zones whic h are locat ed in the territory of more than one Member State; 
(b)  derogations from the requirement for appro val by the Commission of disease–free status for one or more liste d 
diseases referred to in points (b) and (c) of Article 9(1), as laid down in Article 36(1), where such appro val is not 
necessar y on account of detailed rules for freedom from disease having been laid down in rules adopt ed 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 
declarations of disease–free status, without the adopt ion of an implementing act in accordance with Article 36(4), as 
provided for in point (b) of this Article. 
Article 40 
Implementing powers 
The Commission shall, by means of implementing acts, lay down detailed requirements concer ning the information to 
be provided by Member States to the Commission and the other Member States to substantiate declarations of disease– 
free status of territories, zones and compar tments in accordance with Articles 36 to 39, and the format and procedures 
for: 
(a)  applications for recognition of disease–free status of the entire territory of the Member State concer ned, or zones 
and compar tments thereof; 
(b)  exchanges of information between the Member State s and the Commission on disease-free Member States, or zones 
and compar tments thereof. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 41 
Maintenance of disease–free status 
1. Member States shall only maintain disease–free status for their territories, or zones or compar tments thereof, as 
long as: 
(a)  the conditions for disease–free status laid down in Article 36(1) and Article 37(1) and (2), and rules laid down 
pursuant to paragraph 3 of this Article and Article 39, continue to be fulfilled; 
(b)  surveillance, taking into account the requirements provided for in Article 27, is under taken to verify that the 
territory , zone or compar tment concer ned continues to be free of the listed disease for whic h it was appro ved or 
recognised as having disease–free status; 
(c)  restr ictions are applied on movements of animals, and where relevant products derived therefrom, of listed species 
for the listed disease for which the disease–free status was appro ved or recognised, into the territory , zone or 
compar tment concer ned, in accordance with the rules laid down in Parts IV and V; 31.3.2016 L 84/51 Official Jour nal of the European Union EN     (d)  other biosecur ity measures are applied to prevent the introduction of the listed disease for whic h it was appro ved or 
recognised as having disease–free status. 
2. A Member State shall immediately inform the Commission if the conditions refer red to in paragraph 1 for 
maintaining disease–free status are no longer met. 
3. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning the following conditions 
for maintaining disease–free status: 
(a)  surveillance as provided for in point (b) of paragraph 1; 
(b)  biosecur ity measures as provided for in point (d) of paragraph 1. 
Article 42 
Suspension, withdrawal and restoration of disease–free status 
1. Where a Member State becomes awar e, or has reason to suspect, that any of the conditions for maintaining its 
status as a disease–free Member State or zone or compar tment thereof, have been breac hed, it shall immediately: 
(a)  where relevant, depending on the risk, suspend or restr ict movements of the listed species, for the listed disease for 
which it was appro ved or recognised as having disease-free status, to other Member States, zones or compar tments 
with a higher health status for that listed disease; 
(b)  where relevant for the prevention of the spread of a listed disease for which disease–free status has been appro ved 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 investiga tion conf irms that: 
(a)  the suspecte d breac h has not taken place; or 
(b)  the suspected breach has not had a significant impact and the Member State concer ned can provide assurances that 
the conditions for maintaining its disease–free status are again fulfilled. 
3. Where further investigation by the Member State concer ned confir ms that there has been an outbreak of the listed 
disease for which it obtained disease–free status, or that other signif icant breac hes of the conditions for maintaining 
disease–free status as refer red to in Article 41(1) have occur red, or where there is a significant likelihood of this having 
occur red, the Member State shall immediately inform the Commission thereof. 
4. The Commission shall, by means of implementing acts, withdraw without undue dela y the appro val of the 
disease–free status of a Member State or zone grant ed in accordance with Article 36(4) or the recognition of the 
disease–free status of a compar tment grant ed in accordance with Article 37(4) after obtaining the information from the 
Member State concer ned that the conditions for maintaining the disease–free status are no longer met. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
5. On duly justif ied imperative grounds of extreme urgency , where the listed disease refer red to in paragraph 3 of this 
Article spreads in a rapid manner , carrying with it the risk of a highly significant impact on animal or public health, the 
econom y or society , the Commission shall adopt immediately applicable implemen ting acts in accordance with the 
procedure provided for in Article 266(3). 
6. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
provisions supplementing the rules for the suspension, withdra wal and restoration of disease–free status set out in 
paragraphs 1 and 2 of this Article. 31.3.2016 L 84/52 Official Jour nal of the European Union EN     PART III 
DISEASE AWARENESS, PREP AREDNESS AND CONTR OL 
TITLE I 
DISEASE AWARENESS AND PREP AREDNESS 
CHAPTER 1 
Conting ency plans and simulation exer cises 
Article 43 
Contingency plans 
1. The Member States shall, after appropr iate consultation of exper ts and relevant stakeholders, draw up, and keep up 
to date , contingenc y plans and, where necessar y, detailed instr uction manuals laying down the measures to be taken in 
the Member State concer ned in the event of the occur rence of a listed disease referred to in point (a) of Article 9(1) or, 
as the case may be, of an emerging disease, in order to ensure a high level of disease awareness and preparedness and 
the ability to launch a rapid response. 
2. Those contingenc y plans and, where applicable, detailed instr uction manuals shall cover at least the following 
matt ers: 
(a)  the establishment of a chain of command within the compet ent author ity and with other public author ities, to 
ensure a rapid and effective decision–making process at Member State , regional and local level; 
(b)  the framew ork for cooperation between the compet ent author ity and the other public author ities and relevant 
stake holders involved, to ensure that actions are take n in a coherent and coordinat ed manner ; 
(c)  access to: 
(i)  facilities; 
(ii)  laborat ories; 
(iii)  equipment ; 
(iv)  personnel; 
(v)  emerg ency funds; 
(vi)  all other appropr iate mater ials and resources necessar y for the rapid and efficient eradication of the listed 
diseases refer red to in point (a) of Article 9(1) or of emerging diseases; 
(d)  the availability of the following centres and groups with the necessar y exper tise to assist the compet ent author ity: 
(i)  a functional central disease control centre; 
(ii)  regional and local disease control centres, as appropr iate for the administrative and geographical situation of the 
Member State concer ned; 
(iii)  operational exper t groups; 
(e)  implementation of the disease control measures provided for in Chapt er 1 of Title II for the listed diseases refer red 
to in point (a) of Article 9(1) and for emerging diseases; 31.3.2016 L 84/53 Official Jour nal of the European Union EN     (f)  provisions on emerg ency vaccination, where appropr iate; 
(g)  principles for the geographical demarcation of the restr icted zones established by the compet ent author ity in 
accordance with Article 64(1); 
(h)  coordination with neighbour ing Member States and neighbour ing third countr ies and territories, where appropr iate. 
Article 44 
Implementing powers for contingency plans 
The Commission shall, by means of implementing acts, lay down necessar y measures concer ning the imp lementation in 
the Member States of the contingency plans provided for in Article 43(1). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 45 
Simulation exercises 
1. The compet ent author ity shall ensure that simulation exer cises concer ning the contingenc y plans provided for in 
Article 43(1) are carried out regularly or at appropr iate intervals: 
(a)  to ensure a high level of disease awareness and preparedness and the ability to launch a rapid response in the 
Member State concer ned; 
(b)  to verify the functionality of those contingenc y plans. 
2. Where feasible and appropr iate, simulation exercises shall be carried out in close collaboration with the compet ent 
author ities of neighbour ing Member States and neighbour ing third countr ies and territories. 
3. Member States shall mak e available to the Commission and to the other Member States, on request, a repor t on 
the main results of the simulation exer cises carried out. 
4. When appropr iate and necessar y, the Commission shall, by means of implementing acts, lay down rules 
concer ning the practical implementation of simulation exercises in the Member State s, relating to: 
(a)  the frequencies of simulation exercises; 
(b)  simulation exer cises covering more than one listed disease refer red to in point (a) of Article 9(1). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 2 
The use of veter inar y medicinal produ cts for disease prevention and control 
Article 46 
The use of veter inar y medicinal products for disease prev ention and control 
1. The Member State s may take measures concer ning the use of veteri nary medicinal products for listed diseases, to 
ensure the most efficient prevention or control of those diseases, provided that such measures are appropr iate or 
necessar y. 31.3.2016 L 84/54 Official Jour nal of the European Union EN     Those measures may cover the following: 
(a)  prohibitions and restr ictions on the use of veterinar y medicinal products; 
(b)  the compulso ry use of veteri nary medicinal products. 
2. Member State s shall take the following criteria into consideration when determining whether or not to use, and 
how to use, veteri nary medicinal products as prevention and control measures for a specif ic listed disease: 
(a)  the disease prof ile; 
(b)  the distr ibution of the listed disease in: 
(i)  the Member State concer ned; 
(ii)  the Union; 
(iii)  where relevant, neighbour ing third countr ies and territories; 
(iv)  third countr ies and territories from whic h animals and products are brought into the Union; 
(c)  the availabi lity and effectiveness of the veteri nary medicinal products in question, and the risks attachin g to them; 
(d)  the availability of diagnostic tests for detecting infections in animals treated with the veteri nary medicinal products 
concer ned; 
(e)  the economic, social, animal welfare and environmental impact of the use of the veterinar y medicinal products 
concer ned compared to other available disease prevention and control strateg ies. 
3. Member States shall take appropr iate preventive measures concer ning the use of vete rinar y medicinal products for 
scientific studies or for the purposes of developing and testing them under controlled conditions to prot ect animal and 
public health. 
Article 47 
Delegation of powers for the use of veter inar y medicinal products 
1. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning what 
might constitute appropr iate and necessar y measures as set out in Article 46, in relation to: 
(a)  prohibitions and restr ictions on the use of veterinar y medicinal products; 
(b)  specifi c conditions for the use of veterinar y medicinal products for a specifi c listed disease; 
(c)  risk-mitigation measures to prevent the spread of liste d diseases through animals treate d with the veteri nary 
medicinal products or products from such animals; 
(d)  surveillance for specific listed diseases following the use of vaccines and other veterinar y medicinal products. 
2. The Commission shall take into account the criteria set out 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 265 shall apply to rules adopt ed pursuant to paragraph 1 of this Article. 31.3.2016 L 84/55 Official Jour nal of the European Union EN     CHAPTER 3 
Antig en, vaccine and diagnostic reagent banks 
Article 48 
The establishment of Union antigen, vaccine and diagnostic reagent banks 
1. For liste d diseases refer red to in point (a) of Article 9(1) in respect of which vaccination is not prohibited by a 
delegat ed act adopt ed pursuant to Article 47, the Commission may establish and be responsible for managing Union 
antig en, vaccine and diagnostic reagent banks for the storag e and replacement of stoc ks of one or more of the following 
biological products: 
(a)  antig ens; 
(b)  vaccines; 
(c)  vaccine mast er seed–st ocks; 
(d)  diagnostic reagents. 
2. The Commission shall ensure that the Union antig en, vaccine and diagnostic reagent banks provided for in 
paragraph 1: 
(a)  store sufficient stoc ks of the appropr iate type of antig ens, vaccines, vaccine mast er seed–st ocks and diagnostic 
reagents for the specific liste d disease in question, taking into account the needs of Member States estimate d in the 
conte xt of the contingency plans provided for in Article 43(1); 
(b)  receive regular supplies and timely replacements of antig ens, vaccines, vaccine mast er seed–st ocks and diagnostic 
reagents; 
(c)  are maintained and moved in conf ormity with the appropr iate biosecur ity, biosafety and bio–containment 
requirements laid down in Article 16(1) and in accordance with delegat ed acts adopt ed pursuant to Article 16(2); 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the manag ement, stora ge and replacement of stoc ks of the Union antig en, vaccine and diagnostic reage nt banks as 
provided for in paragraphs 1 and 2 of this Article; 
(b)  the biosecur ity, biosaf ety and bio–containment requirements for the operation of those banks, respecting the 
requirements provided for in Article 16(1) and taking into account the delegat ed acts adopt ed pursuant to 
Article 16(2). 
Article 49 
Access to the Union antigen, vaccine and diagnosti c reagent banks 
1. The Commission shall, upon request, provide for the deliver y of the biological products refer red to in Article 48(1) 
from the Union antigen, vaccine and diagnostic reage nt banks , provided that stoc ks are available, to: 
(a)  in the first place, Member States; and 
(b)  third countr ies or territori es, provided that such deliver y is primar ily intended to prevent the spread of a disease into 
the Union. 
2. The Commission shall, in the event of the limited availabi lity of stoc ks, prioritise access to the stoc ks to be 
delivered pursuant to paragraph 1 based on: 
(a)  the disease circumstances under which the request is made; 31.3.2016 L 84/56 Official Jour nal of the European Union EN     (b)  the existen ce of a national antig en, vaccine and diagnostic reagent bank in the requesting Member State or third 
countr y or territory ; 
(c)  the existen ce of Union measures for compul sory vaccination laid down in deleg ated acts adopt ed pursuant to 
Article 47. 
Article 50 
Implementing powers concer ning the Union antigen, vaccine and diagnostic reagent banks 
1. The Commission shall, by means of implementing acts, lay down rules for Union antig en, vaccine and diagnostic 
reagent banks, specifying for the biological products refer red to in Article 48(1): 
(a)  which of those biological products are to be included in the Union antig en, vaccine and diagnostic reagent banks 
and for which of the listed diseases referred to in point (a) of Article 9(1); 
(b)  the types of those biological products that are to be included in the Union antig en, vaccine and diagnostic reagent 
banks and in what quantities for each specifi c listed disease refer red to in point (a) of Article 9(1) for which the bank 
in question exists; 
(c)  the requirements concer ning the supply , storag e and replacement of those biological products; 
(d)  the deliver y of those biological products from the Union antigen, vaccine and diagnostic reagent banks to the 
Member States and to third countr ies and territories; 
(e)  procedural and technical requirements for the inclusion of those biological products in the Union antig en, vaccine 
and diagnostic reage nt banks and for requesting access to them. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
2. On duly justified imperativ e grounds of urgency relating to a listed disease referred to in point (a) of Article 9(1) 
representing a risk of a highly significant impact, the Commission shall adopt immediat ely applicable implementing acts 
in accordance with the procedure provided for in Article 266(3). 
Article 51 
Conf identiality of informa tion concer ning the Union antigen, vaccine and diagnosti c reagent banks 
Information on the quantities and subtypes of the biological products referred to in Article 48(1) stored in the Union 
antig en, vaccine and diagnostic reagent banks shall be treated by the Commission as classified information and shall not 
be published. 
Article 52 
National antigen, vaccine and diagnost ic reagent bank s 
1. Member States that have established national antig en, vaccine and diagnostic reage nt banks for liste d diseases 
referred to in point (a) of Article 9(1) for which Union antigen, vaccine and diagnostic reagent banks exist, shall ensure 
that their national antigen, vaccine and diagnostic reagent banks comply with the biosecur ity, biosaf ety and bio– 
containment requirements laid down in point (a) of Article 16(1) and in delegat ed acts adopt ed in accordance with 
Article 16(2) and point (b) of Article 48(3). 
2. Member States shall provide the Commission with up–t o–date information on: 
(a)  the existence or the establishment of the national antigen, vaccine and diagnostic reage nt banks refer red to 
paragraph 1; 31.3.2016 L 84/57 Official Jour nal of the European Union EN     (b)  the types of antig ens, vaccines, vaccine mast er-seed stoc ks and diagnostic reagents and the quantities thereof held in 
such banks; 
(c)  any chang es in the operation of such banks . 
That information shall be treated as classif ied information by the Commission and shall not be published. 
3. The Commission may, by means of imple menting acts, lay down rules specifying the cont ent, frequency and 
format of the submission of the information provided for in paragraph 2. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
TITLE II 
DISEASE CONTR OL MEASURES 
CHAPTER 1 
Disease control measur es for listed diseases as referred to in point (a) of Article 9(1) 
Section 1 
Disease control measures in the event of suspicion of a liste d disease in kept 
animals 
Article 53 
Obligations on operators and other relevant natural and legal persons concer ned 
1. In the event of suspicion of a liste d disease as referred to in point (a) of Article 9(1) in kept animals, in addition to 
compl ying with the notification oblig ation laid down in Article 18(1) and pending any disease control measures being 
take n by the compet ent author ity in accordance with Articles 54(1) and 55(1), Member States shall take measures to 
ensure that operators and other relevant natural and legal persons concer ned take the appropr iate disease control 
measures provided for in points (c), (d) and (e) of Article 55(1), to prevent the spread of that listed disease from the 
affected animals, establishments and locations under their responsibility to other unaffect ed animals or to humans. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning detailed 
rules for supplementing the disease control measures provided for in paragraph 1 of this Article. 
Article 54 
Investigat ion by the competent author ity in the event of suspicion of a listed disease 
1. In the event of suspicion of a listed disease as refer red to in point (a) of Article 9(1) in kept animals, the compe tent 
author ity shall conduct without dela y an investigat ion to conf irm or rule out the presence of that listed disease. 
2. For the purpose of the investigation provided for in paragraph 1, the compet ent author ity shall, when appropr iate, 
ensure that: 
(a)  official vete rinar ians carry out a clinical examination of a representative sample of the kept animals of listed species 
for the listed disease in question; 
(b)  official veterinar ians take appropr iate sam ples from those kept animals of liste d species and other samples for 
examination in laborat ories designated for that purpose by the compe tent author ity; 31.3.2016 L 84/58 Official Jour nal of the European Union EN     (c)  such designated laboratori es carry out examinations to conf irm or rule out the presence of the listed disease in 
question. 
3. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning detailed rules supple ­
menting the rules for investig ations by compet ent author ities as provided for in paragraph 1 of this Article. 
Article 55 
Preliminar y disease control measures by competent author ities 
1. The compet ent author ity shall, in the event that it suspects the presence of a listed disease as refer red to in 
point (a) of Article 9(1) in kept animals, carry out the following preliminar y disease control measures, subject to 
national requirements for gaining access to private residences, pending the results of the investigat ion provided for in 
Article 54(1) and the carrying-out of the disease control measures provided for in Article 61(1): 
(a)  place the establishment, food and feed business or animal by–products establishment concer ned, or any other 
location where the disease is suspect ed of having occur red, including locations where the suspected disease may have 
originated, under official surveillance; 
(b)  compile an invent ory of: 
(i)  the kept animals in the establishment, food and feed business, or animal by–products establishment concer ned, 
or in any other location; 
(ii)  the products in that establishment, food and feed business, or animal by–products establishment, or in any other 
location, where relevant for the spread of that listed disease; 
(c)  ensure that appropr iate biosecur ity measures are applied to prevent the spreading of that listed disease agent to 
other animals or to humans; 
(d)  when appropr iate to prevent the further spread of the disease agent, ensure that the kept animals of listed species 
for that listed disease are isolated, and that they are prevented from coming into contact with wildlif e; 
(e)  restr ict the movements of kept animals, products and, if appropr iate, people, vehicles and any mater ial or other 
means by which the disease agent could have spread to or from the establishment, food and feed business or animal 
by–pr oducts establishment, or from any other location where that liste d disease is suspect ed, as far as necessar y to 
prevent its spread; 
(f)  take any other necessar y disease control measures, taking into account the disease control measures provided for in 
Section 4 of this Chapt er, concer ning: 
(i)  the application of the inve stigation by the compet ent author ity provided for in Article 54(1) and disease control 
measures provided for in points (a) to (d) of this paragraph to other establishments, food and feed businesses, or 
animal by–products establishments, or to any other location; 
(ii)  the establishment of any temporar y restr icted zones which are appropr iate, taking into account the disease 
prof ile; 
(g)  initiate the epidemiological enquir y provided for in Article 57(1). 
2. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning detailed rules supple ­
menting those laid down in paragraph 1 of this Article as regar ds the specific and detailed disease control measures to 
be taken depending on the listed disease refer red to in point (a) of Article 9(1), based on the risks involved for: 
(a)  the species or catego ry of animals concer ned; 
(b)  the type of production concer ned. 31.3.2016 L 84/59 Official Jour nal of the European Union EN     Article 56 
Review and extension of the preliminar y disease control measures 
The disease control measures provided for in Article 55(1) shall be: 
(a)  reviewed by the compe tent author ity, as appropr iate, following the findings of: 
(i)  the investig ation provided for in Article 54(1); 
(ii)  the epidemiological enquir y provided for in Article 57(1); 
(b)  further extende d to other locations as referred to in point (a) of Article 55(1), where necessar y. 
Section 2 
Epidemiological enquir y 
Article 57 
Epidemiological enquir y 
1. The compet ent author ity shall carry out an epidemiological enquir y in the event of the conf irmation of a liste d 
disease as refer red to in point (a) of Article 9(1) in animals. 
2. The epidemiological enquir y provided for in paragraph 1 shall aim to: 
(a)  identify the likely origin of the liste d disease in question and the means of its spread; 
(b)  calculat e the likely length of time that the listed disease has been present ; 
(c)  identify establishments and epidemiological units therein, food and feed businesses or animal by–products 
establishments, or other locations, where animals of listed species for the suspecte d liste d disease may have become 
infected, infest ed or contaminated ; 
(d)  obtain information on the movements of kept animals, persons, products, vehicles, any mater ial or other means by 
which the disease agent could have been spread during the relevant period preceding the notificati on of the 
suspicion or confir mation of the listed disease; 
(e)  obtain information on the likely spread of the listed disease in the surrounding environment, including the presence 
and distr ibution of disease vect ors. 
Section 3 
Disease conf irmation in kept animals 
Article 58 
Official conf irmation by the competent author ity of a listed disease as refer red to in point (a) of 
Article 9(1) 
1. The compet ent author ity shall base an official conf irmation of a liste d disease as refer red to in point (a) of 
Article 9(1) on the following information: 
(a)  the results of the clinical and laboratory examinations provided for in Article 54(2); 31.3.2016 L 84/60 Official Jour nal of the European Union EN     (b)  the preliminar y or final results of the epidemiological enquir y provided for in Article 57(1); 
(c)  other available epidemiological data. 
2. The Commission shall adop t delega ted acts in accordance with Article 264 concer ning the requirements to be 
fulfilled for the official conf irmation referred to in paragraph 1 of this Article. 
Article 59 
Lifting of preliminar y disease control measures where the presence of the listed disease has been 
ruled out 
The compet ent author ity shall continue to apply the preliminar y disease control measures provided for in Article 55(1) 
and Article 56 until the presence of the listed disease in question, as referred to in point (a) of Article 9(1), has been 
ruled out on the basis of the information refer red to in Article 58(1) or rules adop ted pursuant to Article 58(2). 
Section 4 
Disease control measures in the event of conf irmation of disease in kept animals 
Article 60 
Immediate disease control measures to be taken by the competent author ity 
In the event of an official confir mation in accordance with Article 58(1) of an outbreak of a liste d disease as refer red to 
in point (a) of Article 9(1) in kept animals, the compet ent author ity shall immediat ely: 
(a)  declare the affect ed establishment, food or feed business, animal by–products establishment or other location as 
official ly infected with that listed disease; 
(b)  establish a restr icted zone appropr iate for that listed disease; 
(c)  imp lement 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 as refer red to in point (a) of Article 9(1) in kept animals, the 
compet ent author ity shall immediately take one or more of the following disease control measures, subject to national 
requirements for gaining access to private residences, in an establishment, food or feed business, animal by–products 
establishment, or any other location refer red to in point (a) of Article 60, in order to prevent the further spread of that 
listed disease: 
(a)  the imposition of restr ictions on movements of persons, animals, products, vehicles or any other mater ial or 
substance that may be contaminated and contr ibut e to the spread of the listed disease; 
(b)  the killing and disposal or slaughteri ng of animals that may be contaminated or contr ibut e to the spread of the 
listed disease; 31.3.2016 L 84/61 Official Jour nal of the European Union EN     (c)  the destr uction, processing, transf ormation or treatment of products, feed, or any other substances, or the treatment 
of equipment, means of transpor t, plants or plant products, or wate r which may be contaminate d, as appropr iate to 
ensure that any disease agent or vect or of the disease agent is destro yed; 
(d)  the vaccination or treatment with other veter inar y medicinal products of kept animals in accordance with 
Article 46(1) and Article 69 and any delegat ed acts adop ted pursuant to Article 47; 
(e)  the isolation, quarantine or treatment of animals and products that are likely to be contaminate d and contr ibute to 
the spread of the listed disease; 
(f)  the cleaning, disinf ection, control of insects and rodents, or other necessar y biosecur ity measures to be applied to 
the affected establishment, 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 suffi cient number of appropr iate samples needed to compl ete the epidemiological enquir y provided 
for in Article 57(1); 
(h)  the laboratory examination of samples; 
(i)  any other appropr iate measures. 
2. When determining which of the disease control measures provided for in paragraph 1 are appropr iate to take, the 
compet ent author ity shall take the following into account: 
(a)  the disease prof ile; 
(b)  the type of production, and epidemiological units within the affected establishment, food or feed business, animal 
by–pr oducts establishment or other location; 
3. The compet ent author ity shall only author ise the repopulation of the establishment concer ned, or of any other 
location, when: 
(a)  all appropr iate disease control measures and laborat ory examinations provided for in paragraph 1 have been 
successfully compl eted; 
(b)  a suffi cient period of time has elapsed to prevent re–contamination of the affected establishment, food or feed 
business, animal by–products establishment or other location with the listed disease that caused the outbreak 
refer red to in paragraph 1. 
Article 62 
Epidemiologically linked establishments and locations 
1. The compet ent author ity shall extend the disease control measures provided for in Article 61(1) to other 
establishments, epidemiological units therein, food or feed businesses, or animal by–products establishments, or any 
other location, or means of transpor t where the epidemiological enquir y provided for in Article 57(1) or the results of 
clinical or laboratory investig ations or other epidemiological data, give reason to suspect the spread to, from or through 
them of the listed disease refer red to in point (a) of Article 9(1) in respect of which such measures were taken. 
2. If the epidemiological enquir y provided for in Article 57(1) shows that the likely origin of the listed disease 
referred to in point (a) of Article 9(1) is another Member State, or if it is likely that that liste d disease has spread to 
another Member State, the compet ent author ity shall inform that Member State and the Commission without dela y. 
3. Should any of the events referred to in paragraph 2 occur , the compet ent author ities of the diffe rent Member 
States shall cooperate in a further epidemiological enquir y and in the application of disease control measures. 31.3.2016 L 84/62 Official Jour nal of the European Union EN     Article 63 
Delegation of powers in respect of disease control measures in affected and epidemiologically 
link ed establishments and other locations 
The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning detailed rules on the disease 
control measures to be taken by the compet ent author ity in accordance with Articles 61 and 62 in affected and 
epidemiologically linked establishments, food or feed businesses, or animal by–products establishments, and other 
locations in respect of any listed disease refer red to in point (a) of Article 9(1), including rules on whic h disease control 
measures refer red to in Article 61(1) are to be applied in relation to each listed disease. 
Those detailed rules shall cover the following matte rs: 
(a)  the conditions and requirements for the disease control measures provided for in points (a) to (e) of Article 61(1); 
(b)  the procedures for cleaning, disinfection, control of insects and rodents, or other necessar y biosecur ity measures as 
provided for in point (f) of Article 61(1), specifying, where appropr iate, the use of biocidal products for those 
purposes; 
(c)  the conditions and requirements for sampli ng and laborat ory examination as provided for in points (g) and (h) of 
Article 61(1); 
(d)  the detailed conditions and requirements in respect of repopulation as provided for in Article 61(3); 
(e)  the carrying-out of the necessar y disease control measures provided for in Article 62 in epidemiologically linked 
establishments, other locations and means of transpor t. 
Article 64 
Establishment of restricted zones by the competent author ity 
1. The compet ent author ity shall establish a restr icted zone as refer red to in point (b) of Article 60 around the 
affected establishment, food or feed business, animal by–products establishment or other location where the outbreak of 
a liste d disease as refer red to in point (a) of Article 9(1) in kept animals has occur red, where appropr iate taking into 
account: 
(a)  the disease prof ile; 
(b)  the geographical situation of the restr icted zone; 
(c)  the ecological and hydrological factors of the restr icted zone; 
(d)  the mete orological conditions; 
(e)  the presence, distr ibution and type of vect ors in the restr icted zone; 
(f) the results of the epidemiological enquir y provided for in Article 57(1) and other studies carried out and epidemiol ­
ogical data; 
(g)  the results of laborat ory tests; 
(h)  the disease control measures applied; 
(i)  other relevant epidemiological factors. 
The restr icted zone shall include, when appropr iate, a prote ction and surveillance zone of a defined size and 
conf iguration. 31.3.2016 L 84/63 Official Jour nal of the European Union EN     2. The compet ent author ity shall continuously assess and review the situation and, when appropr iate in order to 
prevent the spread of the listed disease refer red to in point (a) of Article 9(1), shall: 
(a)  adapt the boundar ies of the restr icted zone; 
(b)  establish additional restr icted zones. 
3. Where restr icted zones as provided for in paragraph 1 are situated in the territory of more than one Member State, 
the compet ent author ities of those Member States shall cooperate in establishing them. 
4. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning detailed rules for the 
establishment and modification of restr icted zones, including protection or surveillance zones. 
Article 65 
Disease control measures in rest ricted zones 
1. The compet ent author ity shall ensure that, subject to national requirements for gaining access to private residences, 
one or more of the following disease control measures are taken in the restr icted zone concer ned, in order to prevent 
the further spread of a listed disease as referred to in point (a) of Article 9(1): 
(a)  the identif ication of establishments, food or feed businesses, animal by–products establishments or other locations 
with kept animals of listed species for that liste d disease; 
(b)  visits to establishments, food or feed businesses, animal by–products establishments or other locations with kept 
animals of listed species for that listed disease, and, where necessar y, examinations, sampling and laborat ory 
examination of the sam ples take n; 
(c)  the imposition of conditions for the movement of persons, animals, products, feed, vehicles and any other mate rial 
or substance that may be contaminated or contr ibute to the spread of that listed disease within and from the 
restr icted zone and transpor t through the restr icted zone; 
(d)  biosecur ity requirements for: 
(i)  the production, processing and distr ibution of products of animal origin; 
(ii)  the collection and disposal of animal by–products; 
(iii)  the collection, storag e and handling of germinal products; 
(e)  the vaccination and treatment with other veteri nary medicinal products of kept animals in accordance with 
Article 46(1) and any delegat ed acts adopt ed pursuant to Article 47; 
(f)  cleaning, disinf ection, control of insects and rodents, or other necessar y biosecur ity measures; 
(g)  the designation or where relevant, appro val of a food business establishment for the purposes of the slaughter ing of 
animals or the treatment of products of animal origin originating from the restr icted zone; 
(h)  the identif ication and traceability requirements for the movement of animals, germinal products or products of 
animal origin; 
(i)  other necessar y biosecur ity and risk-mitig ating measures to minimise the risk of the spread of that listed disease. 
2. The compet ent author ity shall: 
(a)  take all necessar y measures to fully inform persons in the restr icted zone of the restr ictions in force and the nature 
of the disease control measures; 
(b)  imp ose the necessar y obligations on operat ors in order to prevent the further spread of the listed disease in 
question. 31.3.2016 L 84/64 Official Jour nal of the European Union EN     3. When determining whic h of the disease control measures provided for in paragraph 1 are to be taken, the 
compet ent author ity shall take the following into account: 
(a)  the disease prof ile; 
(b)  the types of production; 
(c)  the feasibility , availability and effectiveness of those disease control measures. 
Article 66 
Operat ors' obligations regarding movements in rest ricted zones 
1. In restr icted zones as provided for in Article 64(1), operat ors shall only move the kept animals and products with 
the permission of the compet ent author ity and in accordance with any instr uctions given by that author ity. 
2. Operato rs keeping animals and products in a restr icted zone as provided for in Article 64(1) shall notify to the 
compet ent author ity intended movements of kept animals and products within or out of the restr icted zone in question. 
In so far as the compet ent author ity has imposed notifi cation oblig ations in accordance with point (b) of Article 65(2), 
the operat ors concer ned shall notify in accordance with those oblig ations. 
Article 67 
Delegation of powers concer ning disease control measures in rest ricted zones 
The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning detailed rules on the disease 
control measures to be taken in restr icted zones as provided for in Article 65(1) for each listed disease refer red to in 
point (a) of Article 9(1), including rules on whic h disease control measures referred to in Article 65(1) are to be applied 
in the case of each listed disease. 
Those detailed rules shall cover the following matte rs: 
(a)  the conditions and requirements for the disease control measures provided for in points (a), (c), (d), (e), (g), (h) and (i) 
of Article 65(1); 
(b)  the procedures for cleaning, disinfection, control of insects and rodents, or other necessar y biosecur ity measures as 
provided for in point (f) of Article 65(1), specifying, where appropr iate, the use of biocidal products for those 
purposes; 
(c)  the necessar y surveillance which is to be conduct ed following the application of the disease control measures and 
laboratory examinations provided for in point (b) of Article 65(1); 
(d)  other specifi c disease control measures to limit the spread of specif ic listed diseases as refer red to in point (a) of 
Article 9(1). 
Article 68 
Mainta ining disease control measures in rest ricted zones and delegated acts 
1. The compet ent author ity shall continue to apply the disease control measures provided for in this Section until the 
following conditions are met: 
(a)  the disease control measures appropr iate to the liste d disease refer red to in point (a) of Article 9(1) for whic h they 
were applied have been carried out; 
(b)  the final cleaning, disinf ection, control of insects and rodents, or other necessar y biosecur ity measures has been 
carried out as appropr iate for: 
(i)  the listed disease refer red to in point (a) of Article 9(1) for whic h the disease control measures have been 
applied; 31.3.2016 L 84/65 Official Jour nal of the European Union EN     (ii)  the affected species of kept animals; 
(iii)  the type of production; 
(c)  adequate surveillance, as appropr iate for the listed disease refer red to in point (a) of Article 9(1) for which the 
disease control measures have been applied, and for the type of establishment or location concer ned, has been 
carried out in the restr icted zone substantiating the eradication of that liste d disease. 
2. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning detailed rules for the 
disease control measures to be taken by the compet ent author ity, as provided for in paragraph 1, in relation to: 
(a)  the final procedures for cleaning, disinf ection, control of insects and rodents, or other necessar y biosecur ity 
measures and, where appropr iate, the use of biocidal products for those purposes; 
(b)  the design, means, methods, frequency , intensity , target ed animal population and sam pling patte rns of surveillance 
aimed at the restoration of disease–free status after the outbreak; 
(c)  repopulation of the restr icted zone concer ned 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). 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning detailed 
rules for the disease control measures to be taken by the compet ent author ity, as provided for in paragraph 1, in 
relation to other disease control measures necessar y for the restoration of disease–free status. 
Article 69 
Emergency vaccination 
1. Where relevant for the effective control of a listed disease as refer red to in point (a) of Article 9(1) for whic h 
disease control measures apply , the compet ent author ity may: 
(a)  develop a vaccination plan; 
(b)  establish vaccination zones. 
2. When deciding on the vaccination plan and the establishment of vaccination zones as provided for in paragraph 1, 
the compet ent author ity shall take the following into account: 
(a)  the requirements for emerg ency vaccination set out in the contingency plans provided for in Article 43; 
(b)  the requirements for the use of vaccines as provided for in Article 46(1) and any delegat ed acts adopt ed pursuant to 
Article 47. 
3. Vaccination zones as provided for in point (b) of paragraph 1 of this Article shall meet the requirements in respect 
of risk-mitig ating measures to prevent the spread of listed diseases and surveillance as laid down in any delegat ed acts 
adopt ed in accordance with points (c) and (d) of Article 47(1). 
Section 5 
Wild animals 
Article 70 
Wild animals 
1. Where the compet ent author ity of an affect ed Member State suspects or officially confir ms the presence of a liste d 
disease as refer red to in point (a) of Article 9(1) in wild animals, it shall: 
(a)  conduct, where relevant for that particular liste d disease, surveillance in the wild animal population; 
(b)  take the necessar y disease prevention and control measures. 31.3.2016 L 84/66 Official Jour nal of the European Union EN     2. The disease prevention and control measures provided for in point (b) of paragraph 1 of this Article may include 
one or more of the measures laid down in Article 53 to 69 and shall take into account the disease profile and the 
affected wild animals and the risk of transmission of diseases to animals and humans. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  criteria and procedures for surveillance pursuant to point (a) of paragraph 1 of this Article in the case of official 
conf irmation of a listed disease as referred to in point (a) of Article 9(1), in accordance with Article 27; 
(b)  detailed rules supplementing the disease prevention and control measures to be taken pursuant to point (b) of 
paragraph 1 of this Article in the case of official conf irmation of a listed disease as refer red to in point (a) of 
Article 9(1). 
When adopting those delegat ed acts, the Commission shall take into account the disease prof ile and the listed species for 
the liste d disease referred to paragraph 1 of this Article. 
Section 6 
Additional disease control measures by the Member States, coordination by the 
Commission and temporar y special disease control rules 
Article 71 
Addition al disease control measures, coordination of measures and temporar y special disease 
control rules concer ning Sections 1 to 5 (Articles 53 to 70) 
1. Member State s may take disease control measures additional to those provided for in Article 55, Article 61(1), 
Article 62, Article 65(1) and (2) and Article 68(1) and in any delegat ed acts adopt ed pursuant to Article 63, Article 67 
and Article 68(2), provided that such measures respect the rules laid down in this Regulation and are necessar y and 
propor tionate to control the spread of a listed disease as referred to in point (a) of Article 9(1), taking into account: 
(a)  the particular epidemiological circumstances; 
(b)  the type of establishments, other locations and production concer ned; 
(c)  the species and categor ies of animals involved; 
(d)  economic or social conditions. 
2. Member States shall inform the Commission without dela y of: 
(a)  the disease control measures taken by their compet ent author ity as provided for in Articles 58, 59, 61, 62, 64 
and 65, Article 68(1), Article 69 and Article 70(1) and (2) and in any delega ted acts adopt ed pursuant to Articles 63 
and 67 and Articles 68(2) and 70(3); 
(b)  any additional disease control measures taken by them as provided for in paragraph 1. 
3. The Commission shall review the disease situation and the disease control measures taken by the compet ent 
author ity and any additional disease control measures taken by the Member State concer ned, in accordance with this 
Chapt er, and may, by means of implementing acts, lay down special disease control measures for a limited period of 
time, under conditions appropr iate to the epidemiological situation, where: 
(a)  those disease control measures are found not to be suited to the epidemiological situation; 
(b)  the listed disease refer red to in point (a) of Article 9(1) appears to be spreading despite the disease control measures 
taken in accordance with this Chapt er. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
4. On duly justified imperative grounds of urgency relating to a disease representing an emerging risk of a highly 
signif icant impa ct, the Commission shall adopt immediately applicable implementing acts in accordance with the 
procedure refer red to in Article 266(3). 31.3.2016 L 84/67 Official Jour nal of the European Union EN     CHAPTER 2 
Disease control measur es for listed diseases as referred to in points (b) and (c) of Article 9(1) 
Section 1 
Disease control measures in the event of suspicion of disease in kept animals 
Article 72 
Obligations on operat ors and other relevant natural and legal persons concer ned in relation to 
listed diseases as refe rred to in point (b) of Article 9(1) 
1. In the event of suspicion of a listed disease as refer red to in point (b) of Article 9(1) in kept animals, in addition to 
compl ying with the notification oblig ation laid down in Article 18(1) and pending any disease control measures being 
take n by the compe tent author ity in accordance with Article 74(1), Member State s shall take measures to ensure that 
operat ors and other relevant natural and legal persons concer ned take disease control measures as refer red to in 
point (a) of Article 74(1) and in any delegat ed acts adopt ed pursuant to Article 74(4), to prevent the spread of that listed 
disease from the affected animals, establishments and other locations under their responsibility to other unaffect ed 
animals or to humans. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning detailed 
rules for supplementing the disease control measures as provided for in paragraph 1 of this Article. 
Article 73 
Investigation by the competent author ity in the event of suspicion of a listed disease as refer red to 
in point (b) of Article 9(1) 
1. In the event of suspicion of a liste d disease as refer red to in point (b) of Article 9(1) in kept animals, the 
compet ent author ity shall conduct without dela y an investigat ion to confir m or rule out the presence of that listed 
disease. 
2. For the purpose of the investigation provided for in paragraph 1, the compet ent author ity shall ensure that : 
(a)  official vete rinar ians carry out a clinical examination of a representative sample of the kept animals of listed species 
for the listed disease in question; 
(b)  official veterinar ians take appropr iate sam ples from those kept animals of liste d species and other samples for 
examination in laborat ories designated for that purpose by the compe tent author ity; 
(c)  such designated laboratori es carry out examinations to conf irm or rule out the presence of the listed disease in 
question. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning detailed 
rules supplementing the rules for investigat ions as provided for in paragraph 1 of this Article. 
Article 74 
Preliminar y disease control measures by the competent author ity for listed diseases as refer red to 
in point (b) of Article 9(1) 
1. The compet ent author ity shall, in the event that it suspects a listed disease as refer red to in point (b) of Article 9(1) 
in kept animals, carry out the following preliminar y disease control measures, subject to national requirements for 
gaining access to private residences, pending the results of the investig ation provided for in Article 73(1) and the 
carrying-out of the disease control measures provided for in Article 79: 
(a)  apply disease control measures to limit the spread of that listed disease from the affected territory , establishment, 
food or feed business, animal by–products establishment or other location; 31.3.2016 L 84/68 Official Jour nal of the European Union EN     (b)  initiate , where necessar y, an epidemiological enquir y, taking into account the rules for such enquir y laid down in 
Article 57(1). 
2. In addition to the measures referred to in paragraph 1, the compet ent author ity may, in the cases refer red to in 
that paragraph, take additional preliminar y disease control measures, provided that those measures respect the 
provisions of this Regulation and are in accordance with Union law. 
3. The preliminar y disease control measures provided for in paragraphs 1 and 2 shall be appropr iate and propor ­
tionate to the risk posed by the listed disease in question, taking into account the following: 
(a)  the disease prof ile; 
(b)  the kept animals affected; 
(c)  the health status of the Member State, zone, compar tment or establishment in whic h the liste d disease is suspect ed; 
(d)  the preliminar y disease control measures provided for in Article 55(1) and Article 56 and in any delegat ed act 
adopt ed pursuant to Article 55(2). 
4. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning rules for listed diseases as 
referred to in point (b) of Article 9(1) supplementing those laid down in paragraph 1 of this Article, while taking into 
account the matters referred to in paragraph 3, as regards: 
(a)  the preliminar y disease control measures to be taken to prevent the spread of the listed disease, as provided for in 
point (a) of paragraph 1; 
(b)  the application of the preliminar y disease control measures provided for in point (a) of paragraph 1 to other 
establishments, epidemiological units therein, food or feed businesses and animal by–products establishments or 
other locations; 
(c)  the establishment of temporar y restr icted zones which are appropr iate in light of the disease prof ile. 
Article 75 
Review and extension of the preliminar y disease control measures for listed diseases as referred to 
in point (b) of Article 9(1) 
The disease control measures provided for in Article 74(1) shall be: 
(a)  reviewed by the compet ent author ity, as appropr iate, following the findings of the investig ation provided for in 
Article 73(1) and, where relevant, the epidemiological enquir y provided for in point (b) of Article 74(1); 
(b)  further extende d to other locations, as referred to in point (b) of Article 74(4), where necessar y. 
Article 76 
Obligations of operat ors and other relevant natural and legal persons and measures to be taken by 
the competent author ity in the event of suspicion of listed diseases as refer red to in point (c) of 
Article 9(1) 
1. In the event of suspicion of a listed disease as referred to in point (c) of Article 9(1) in a Member State that has 
opted for the eradication programme covering the relevant parts of its territory or zones or compar tments thereof, as 
provided for in Article 31(2), that Member State shall take measures to ensure that operat ors and other relevant natural 
and legal persons concer ned take appropr iate measures as provided for in Article 72(1), pending any disease control 
measures being take n by the compet ent author ity in accordance with paragraph 2 of this Article. 
2. The compet ent author ity of a Member State that has opted for the eradication of a listed disease as referred to in 
paragraph 1 shall, in the event that it suspects the disease in question in kept animals: 
(a)  conduct without dela y an inve stigation to conf irm or rule out the presence of that listed disease in accordance with 
Article 73(1) and (2); 31.3.2016 L 84/69 Official Jour nal of the European Union EN     (b)  pending the results of the investigation provided for in point (a) and the carrying-out of disease control measures in 
accordance with Article 80(1), carry out the preliminar y disease control measures provided for in Article 74(1) 
and (2). 
3. The compet ent author ity shall review and exte nd the preliminar y disease control measures referred to in point (b) 
of paragraph 2, in accordance with Article 75. 
4. Paragraphs 1, 2 and 3 of this Article shall also apply to Member States or zones which have obtained disease–free 
status, in order to maintain that status, in accordance with Article 36, or to compar tments in accordance with 
Article 37(2). 
5. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning detailed 
rules supplementing rules in respect of: 
(a)  the disease control measures provided for in paragraph 1; 
(b)  the inve stigation provided for in point (a) of paragraph 2; 
(c)  the preliminar y disease control measures to be taken to prevent the spread of the listed disease, as provided for in 
point (b) of paragraph 2. 
Section 2 
Disease conf irmation in kept animals 
Article 77 
Official conf irmation of disease by the competent author ity 
1. The compet ent author ity shall base an official conf irmation of a listed disease as refer red to in point (b) or (c) of 
Article 9(1) on the following information: 
(a)  the results of the clinical and laboratory examinations provided for in Article 73(2); 
(b)  the epidemiological enquir y provided for in point (b) of Article 74(1), where relevant ; 
(c)  other available epidemiological data. 
2. The Commission shall adop t delega ted acts in accordance with Article 264 concer ning the requirements to be 
fulfilled for the official conf irmation referred to in paragraph 1. 
Article 78 
Lifting preliminar y disease control measures when the occur rence of a disease is ruled out 
The compet ent author ity shall continue to apply the preliminar y disease control measures provided for in Article 74(1), 
Article 75 and point (b) of Article 76(2) until the presence of the listed disease in question has been ruled out in 
accordance with Article 77(1) and any rules adopt ed pursuant to Article 77(2). 
Section 3 
Disease control measures in the event of conf irmation of disease in kept animals 
Article 79 
Disease control measures by the competent author ity for listed diseases as referred to in point (b) 
of Article 9(1) 
In the event of an official confir mation in accordance with Article 77(1) of an outbreak of a liste d disease as refer red to 
in point (b) of Article 9(1) in kept animals, the compet ent author ity shall, in a Member State, zone or compar tment, as 
relevant for that outbreak: 
(a)  apply the disease control measures laid down in the compul sory eradication programme provided for in 
Article 31(1) for that liste d disease; or 31.3.2016 L 84/70 Official Jour nal of the European Union EN     (b)  where the Member State or zone, or compar tment, has obtained disease–free status in accordance with Article 36 or 
Article 37 respectively: 
(i)  take one or more of the measures laid down in Articles 53 to 69 propor tionate to the risk posed by the liste d 
disease in question, and 
(ii)  where necessar y, initiat e the compul sory eradication programme for that listed disease. 
Article 80 
Disease control measures to be taken by the competent author ity for listed diseases refer red to in 
Article 9(1)(c) 
1. In the event of an official conf irmation in accordance with Article 77(1) of an outbreak of a listed disease as 
referred to in point (c) of Article 9(1) in kept animals in a Member State that has opted for an eradication programme 
covering the relevant parts of its territory or zones or compar tments thereof, as provided for in Article 31(2), as 
relevant for that liste d disease and that outbreak , the compe tent author ity shall apply the disease control measures laid 
down in the optional eradication programme. 
2. The compet ent author ity may take disease control measures additional to those provided for in paragraph 1 which 
may include one or more of the measures laid down in Articles 53 to 69 and shall be propor tionate to the risk posed 
by the listed disease in question and shall take into account: 
(a)  the disease prof ile; 
(b)  the kept animals affected; 
(c)  economic and social impacts. 
3. In the event of an official conf irmation in accordance with Article 77(1) of an outbreak of a listed disease as 
referred to in point (c) of Article 9(1) in kept animals in a Member State , zone or compar tment that has obtained 
disease–free status in accordance with Article 36 or Article 37, and in order to maintain that status, the compet ent 
author ity shall take one or more of the measures laid down in Articles 53 to 69. Those measures shall be propor tionat e 
to the risk posed by the listed disease in question and shall take into account: 
(a)  the disease prof ile; 
(b)  the kept animals affected; 
(c)  economic and social impacts. 
Section 4 
Wild animals 
Article 81 
Disease control measures for listed diseases as referred to in point (b) of Article 9(1) in wild 
animals 
In the event that the compet ent author ity of an affected Member State suspects or officially conf irms the outbreak of a 
listed disease as referred to in point (b) of Article 9(1) in wild animals, it shall throughout its territory , or in the area or 
zone concer ned, as relevant for that outbreak: 
(a)  apply the disease control measures laid down in the compul sory eradication programme provided for in 
Article 30(1) for that liste d disease; or 
(b)  initiate a compul sory eradication programme, where the eradication programme provided for in Article 31(1) for 
that listed disease has not yet been applied due to the previous absence of that disease or freedom from it, and if 
measures for wild animals are necessar y in order to control and prevent the spread of that disease. 31.3.2016 L 84/71 Official Jour nal of the European Union EN     Article 82 
Disease control measures for listed diseases as referred to in point (c) of Article 9(1) in wild 
animals 
1. In the event that a compet ent author ity suspects or officially confir ms a listed disease as refer red to in point (c) of 
Article 9(1) in wild animals and the affected Member State has opted for the eradication of the disease in question, and 
provided that measures for wild animals are envi saged in the optional eradication programme provided for in 
Article 31(2) for that listed disease, the compet ent author ity shall apply the disease control measures laid down in that 
optional eradication programme throughout the territory of the Member State, area or zone concer ned, as relevant for 
that suspicion or official confir mation. 
2. The compet ent author ity may take disease control measures additional to those provided for in paragraph 1, whic h 
may include one or more of the measures laid down in Articles 53 to 69 and shall be propor tionate to the risk posed 
by the listed disease in question and shall take into account: 
(a)  the disease prof ile; 
(b)  the affect ed wild animals and the risk of transmission of diseases to animals and humans; and 
(c)  economic, social and environmental impacts. 
3. In the event of an official confir mation of an outbreak of a listed disease as referred to in point (c) of Article 9(1) 
in wild animals in a Member State, zone or compar tment that has obtained disease–free status in accordance with 
Article 36 or Article 37, and in order to maintain that status, the compet ent author ity shall take one or more of the 
measures laid down in Articles 53 to 69. Those measures shall be propor tionate to the risk posed by the listed disease 
in question and shall take into account: 
(a)  the disease prof ile; 
(b)  the affect ed wild animals and the risk of transmission of diseases to animals and humans; 
(c)  the relevance of the presence of the disease in wild animals in relation to the health status of kept animals; and 
(d)  economic, social and environmental impacts. 
Section 5 
Coordination by the Commission and temporar y special disease control rules 
Article 83 
Coordination of measures by the Commission and temporar y special rules concer ning 
Sections 1 to 4 
1. Member States shall inform the Commission of: 
(a)  disease control measures taken by their compet ent author ities in accordance with Articles 77(1), 78, 79 and 81 and 
with any delegat ed acts adopt ed pursuant to Article 77(2) in respect of a listed disease as refer red to in point (b) of 
Article 9(1); 
(b)  disease control measures take n by their compet ent author ities in accordance with Articles 77(1), 78, 80(1) and 82 
and with any delegat ed acts adopt ed pursuant to Article 77(2) in respect of a listed disease as refer red to in point (c) 
of Article 9(1). 
2. The Commission shall review the disease situation and the disease control measures taken by the compet ent 
author ity in accordance with this Chapt er 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 as referred to in point (b) or point (c) of 
Article 9(1), under conditions appropr iate to the epidemiological situation, where: 
(a) those disease control measures taken by the compet ent author ity in question are found not to be suited to the epi­
demiological situation; 31.3.2016 L 84/72 Official Jour nal of the European Union EN     (b)  that listed disease appears to be spreading despite the disease control measures taken in accordance with this 
Chapt er, where relevant. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
3. On duly justif ied imperative grounds of urgency relating to a listed disease as referred to in point (b) or point (c) of 
Article 9(1) representing an emerging risk of a highly significant impact, the Commission shall adopt immediately 
applicable implementing acts in accordance with the procedure refer red to in Article 266(3). 
PART IV 
REGISTRA TION , APPR OVAL, TRA CEABILIT Y AND MO VEMENTS 
TITLE I 
TERRESTRIAL ANIMALS, GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN FROM 
TERRESTRIAL ANIMALS 
CHAPTER 1 
Registr ation, approv al, recor d-keeping and registers 
Section 1 
Registrati on of est ablishments and cer tain types of operators 
Article 84 
Obligation of operators to register establishments 
1. Operato rs of establishments keeping terrestrial animals or collecting, producing, processing or storing germinal 
products shall, in order for their establishments to be registere d in accordance with Article 93, before they commence 
such activities: 
(a)  inform the compet ent author ity of any such establishment under their responsibility ; 
(b)  provide the compet ent author ity with the following information: 
(i)  the name and address of the operat or concer ned; 
(ii)  the location of the establishment and a descr iption of its facilities; 
(iii)  the categor ies, species and numbers or quantities of kept terrestr ial animals or germinal products which they 
intend to keep on the establishment, and the capacity of the establishment ; 
(iv)  the type of establishment ; and 
(v)  any other aspects of the establishment whic h are relevant for the purpose of determining the risk posed by it. 
2. Operato rs of establishments refer red to in paragraph 1 shall inform the compet ent author ity of: 
(a)  any chang es in the establishment in question concer ning the matte rs referred to in point (b) of paragraph 1; 
(b)  any cessation of activity by the operat or or establishment concer ned. 
3. Establishments whic h are subject to appro val in accordance with Article 94(1) shall not be required to provide the 
information refer red to in paragraph 1 of this Article. 
Article 85 
Derogations from the obligation of operat ors to regis ter establishments 
By way of derog ation from Article 84(1), Member State s may exempt from the registration requirement certain 
catego ries of establishments posing an insignif icant risk, as provided for in an implementing act adopt ed in accordance 
with Article 86(2). Member States shall inform the Commission of such exem ptions. 31.3.2016 L 84/73 Official Jour nal of the European Union EN     Article 86 
Implementing powers concer ning the obligation of operators to register establishments 
1. The Commission may, by means of implementing acts, lay down rules concer ning the information to be provided 
by operat ors for the purpose of the registration of establishments as provided for in Article 84(1), including the time- 
limits by which such information is to be provided. 
2. The Commission shall, by means of implementing acts, lay down rules concer ning the types of establishments that 
may be exem pted by the Member State s from the registration requirement in accordance with Article 85, on the basis 
of: 
(a)  the species, cate gories and numbers of kept terrestrial animals and germinal products on the establishment in 
question and the capacity of that establishment ; 
(b)  the type of establishment ; and 
(c)  the movements of kept terrestr ial animals or germinal products into and out of the establishment. 
3. The implementing acts referred to in this Article shall be adopt ed in accordance with the examination procedure 
referred to in Article 266(2). 
Article 87 
Registration obligations of transpor ters of kep t ungulates and delegated acts 
1. Transpor ters of kept ungulates engag ed in the transpor tation of those animals between Member States or between 
a Member State and a third countr y shall, in order to be registered in accordance with Article 93, before they commence 
such activities: 
(a)  inform the compet ent author ity of their activity ; 
(b)  provide that compet ent author ity with information on: 
(i)  the name and address of the transpor ter concer ned; 
(ii)  the catego ries, species and numbers of kept ungulates for whic h transpor tation is planned; 
(iii)  the type of transpor t; 
(iv)  the means of transpor t. 
2. Transpor ters as refer red to in paragraph 1 shall inform the compet ent author ity of: 
(a)  any chang es concer ning the matt ers refer red to in point (b) of paragraph 1; 
(b)  any cessation of the transpor t activity . 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 supplementing the 
rules provided for in paragraph 1 of this Article, requir ing other types of transpor ters whose transpor t activity poses 
specific and signif icant risks for certain species or catego ries of animals to provide adequate information for the 
purposes of registration of their activity . 
Article 88 
Derogations from the regis tration obligation of transpor ters of kept ungulates 
By way of derog ation from Article 87(1), Member State s may exempt from the registration requirement certain 
catego ries of transpor ters whose transpor t activity poses an insignif icant risk, as provided for in an implementing act 
adopt ed in accordance with Article 89(2). Member States shall inform the Commission of such exem ptions. 31.3.2016 L 84/74 Official Jour nal of the European Union EN     Article 89 
Implementing powers concer ning the regis tration obligation of transpor ters 
1. The Commission may, by means of implementing acts, lay down rules concer ning the information to be provided 
by transpor ters for the purposes of registration of their activity , as provided for in Article 87(1) and (3), including the 
time-limits by which such information is to be provided. 
2. The Commission shall, by means of implementing acts, lay down rules concer ning the types of transpor ters that 
may be exempted by Member States from the registration requirement in accordance with Article 86, on the basis of: 
(a)  the distances over which they transpor t the ungulates in question; and 
(b)  the categor ies, species and number of ungulates which they transpor t. 
3. The implementing acts referred to in this Article shall be adopt ed in accordance with the examination procedure 
referred to in Article 266(2). 
Article 90 
Regis tration obligation of operators conducting assembly operations independently of an 
establishment 
1. Operato rs conducting assembly operations for kept ungulates and poultr y, independently of an establishment, 
including those who buy and sell animals, shall, in order to be registere d in accordance with Article 93, before they 
commence their activities, provide the compet ent author ity with information on: 
(a)  the name and address of the operator concer ned; 
(b)  the species and categor ies of kept ungulates and poultr y covered by their activity . 
2. Operato rs as referred to in paragraph 1 shall inform the compet ent author ity of: 
(a)  any chang es concer ning the matt ers refer red to in paragraph 1; 
(b)  any cessation of activity by the operat or concer ned. 
Article 91 
Derogations from the registrati on obligation of operat ors conducting assembly operations 
By way of derog ation from Article 90(1), Member State s may exempt from the registration requirement certain 
catego ries of operators conducting assembly operations posing an insignif icant risk, as provided for in an imple menting 
act adopt ed in accordance with Article 92(2). Member States shall inform the Commission of such exem ptions. 
Article 92 
Implementing powers concer ning the registration obligation of operat ors conducting assembly 
operations 
1. The Commission may, by means of implementing acts, lay down rules concer ning the information to be provided 
by operators for the purpose of registration as provided for in Article 90(1), including the time-limits by which such 
information is to be provided. 
2. The Commission shall, by means of implementing acts, lay down rules concer ning the types of operat ors that may 
be exem pted by Member States from the registration requirement in accordance with Article 91, provided that the 
activity of such operat ors poses an insignificant risk and on the basis of species, the catego ries and numbers of kept 
terrestr ial animals covered by their activity . 31.3.2016 L 84/75 Official Jour nal of the European Union EN     3. The implementing acts referred to in this Article shall be adopt ed in accordance with the examination procedure 
referred to in Article 266(2). 
Article 93 
Obligation of the competent author ity concer ning registration 
A compe tent author ity shall register: 
(a)  establishments in the register provided for in Article 101(1), where the operator concer ned has provided the 
information required in accordance with Article 84(1); 
(b)  transpor ters in the register provided for in Article 101(1), where the transpor ter concer ned has provided the 
information required in accordance with Article 87(1) and (3); 
(c)  operat ors conducting assembly operations independently of an establishment, in the register provided for in 
Article 101(1), where the operat or concer ned has provided the information required in accordance with 
Article 90(1). 
The compet ent author ity shall assign each establishment, transpor ter and operat or as refer red to in points (a) to (c) of 
the first paragraph with a unique registration number . 
Section 2 
Appro val of cer tain types of establishments 
Article 94 
Appro val of certain establishments and delegated acts 
1. Operato rs of the following types of establishments shall apply to the compet ent author ity for appro val in 
accordance with Article 96(1) and shall not commence their activities until their establishment has been appro ved in 
accordance with Article 97(1): 
(a)  establishments for assembly operations of ungulates and poultr y from whic h those animals are moved to another 
Member State or which receive animals from another Member State; 
(b)  germinal product establishments for bovine, porcine, ovine, capr ine and equine animals from which germinal 
products of those animals are moved to another Member State; 
(c)  hatche ries from which hatching eggs or poultr y are moved to another Member State; 
(d)  establishments keeping poultr y from whic h poultr y 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 whic h poses a signif icant risk and is required to be 
appro ved in accordance with rules laid down in a delegat ed act adop ted in accordance with point (b) of paragraph 3. 
2. Operato rs shall cease activity at an establishment as refer red to in paragraph 1 where: 
(a)  the compet ent author ity withdraws or suspends its appro val in accordance with Article 100(2); or 
(b)  in the event of conditional appro val, granted in accordance with Article 99(3), the establishment in question fails to 
compl y with the outstanding requirements referred to in Article 99(3) and does not obtain a final appro val in 
accordance with Article 97(1). 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  derogations from the requirement for operators of the types of establishments refer red to in points (a) to (d) of 
paragraph 1 to apply to the compet ent author ity for appro val, where those establishments pose an insignif icant risk; 31.3.2016 L 84/76 Official Jour nal of the European Union EN     (b)  the types of establishments whic h must be appro ved in accordance with point (e) of paragraph 1; 
(c)  special rules for the cessation of activities for germinal product establishments as referred to in point (b) of 
paragraph 1. 
4. When adopt ing delega ted acts as provided for in paragraph 3, the Commission shall base those acts on the 
following criteria: 
(a)  the species and categor ies of kept terrestrial animals or germinal products in an establishment ; 
(b)  the number of species and number of kept terrestr ial animals or germinal products kept in an establishment ; 
(c)  the type of establishment and type of production; and 
(d)  the movements of kept terrestr ial animals or germinal products into and out of those types of establishments. 
Article 95 
Appro val of status of conf ined establishments 
Operato rs of establishments wishing to obtain the status of a conf ined establishment shall: 
(a)  apply to the compet ent author ity for appro val in accordance with Article 96(1); 
(b)  move kept animals to or from their establishment in accordance with the requirements provided for in 
Article 137(1) and any delegat ed acts adop ted in accordance with Article 137(2) only after their establishment has 
obtained an appro val of that status from the compe tent author ity in accordance with Articles 97 and 99. 
Article 96 
Obligation of operators to provide informa tion with a view to obtaining appro val and 
implementing acts 
1. Operato rs shall, for the purposes of their application for appro val of their establishment as provided for in 
Article 94(1) and point (a) of Article 95, provide the compet ent author ity with the following information: 
(a)  the name and address of the operator concer ned; 
(b)  the location of the establishment concer ned and a descr iption of its facilities; 
(c)  the cate gories, species and number of kept terrestrial animals or germinal products relevant for the appro val which 
are kept on the establishment ; 
(d)  the type of establishment ; 
(e)  other aspects of the establishment, related to its specific ity, which are relevant in deter mining the risk, if any, posed 
by it. 
2. Operato rs of establishments as refer red to in paragraph 1 shall inform the compet ent author ity of: 
(a)  any chang es in the establishments concer ning the matt ers refer red to in points (a), (b) or (c) of paragraph 1; 
(b)  any cessation of activity by the operat or or establishment concer ned. 
3. The Commission may, by means of implementing acts, lay down rules concer ning the information to be provided 
by operat ors in their application for appro val of their establishment in accordance with paragraph 1, and the time-limits 
by which the information referred to in paragraph 1 and in point (b) of paragraph 2 is to be provided. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 31.3.2016 L 84/77 Official Jour nal of the European Union EN     Article 97 
Granting of, and conditions for, appro val of establishments and delegated acts 
1. Com petent author ities shall only grant appro val of establishments as provided for in Article 94(1) and point (a) of 
Article 95 where such establishments: 
(a)  compl y with the following requirements, where appropr iate, in relation to: 
(i)  quarantine, isolation and other biosecur ity measures taking into account the requirements provided for in 
point (b) of Article 10(1) and any rules adopt ed pursuant to Article 10(2); 
(ii)  surveillance requirements as provided for in Article 24 and, where relevant for the type of establishment 
concer ned and the risk involved, in Article 25; 
(iii)  record-kee ping as provided for in Articles 102 and 103 and any rules adopt ed pursuant to Articles 106 
and 107; 
(b)  have facilities and equipment that are: 
(i)  adequate to reduce the risk of the introduction and spread of diseases to an acceptab le level, taking into account 
the type of establishment concer ned; 
(ii)  of a capacity adequat e for the number of kept terrestr ial animals or the volume of germinal products concer ned; 
(c)  do not pose an unaccep table risk as regards the spread of diseases, taking into account the risk-mitig ation measures 
in place; 
(d)  have adequate ly trained personnel for the activity of the establishment concer ned; 
(e)  have in place a system whic h enables the operat or concer ned to demonstrat e to the compe tent author ity compl iance 
with points (a) to (d). 
2. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  quarantine, isolation and other biosecur ity measures as referred to in point (a)(i) of paragraph 1; 
(b)  surveillance as refer red to in point (a)(ii) of paragraph 1; 
(c)  facilities and equipment as referred to in point (b) of paragraph 1; 
(d)  responsibilities, compe tence and specialised training of personnel and veteri narians as provided for in point (d) of 
paragraph 1 for the activity of germinal products establishments and establishments for assembly operations of 
ungulates and poultr y; 
(e)  the necessar y super vision by the compet ent author ity of germinal products establishments and establishments for 
assembly operations of ungulate s and poultr y. 
3. When establishing the rules to be laid down in the delegat ed acts to be adop ted pursuant to paragraph 2, the 
Commission shall base those rules on the following matt ers: 
(a)  the risks posed by each type of establishment ; 
(b)  the species and categor ies of kept terrestrial animals relevant for the appro val; 
(c)  the type of production concer ned; 
(d)  typical movement patter ns of the type of establishment and species and catego ries of animals kept in those 
establishments. 31.3.2016 L 84/78 Official Jour nal of the European Union EN     Article 98 
Scope of the appro val of establishments 
The compet ent author ity shall expressly specify in the appro val of an establishment granted pursuant to Article 97(1), 
following an application made in accordance with Article 94(1) or point (a) of Article 95: 
(a)  for whic h of the types of establishments referred to in Article 94(1) and Article 95, and in the rules adopt ed 
pursuant to point (b) of Article 94(3), the appro val applies; 
(b)  for which species and cate gories of kept terrestrial animals or germinal products of those species the appro val 
applies. 
Article 99 
Procedures for the granting of appro val by the competent author ity 
1. The compet ent author ity shall establish procedures for operators to follow when applying for appro val of their 
establishments in accordance with Article 94(1), Article 95 or Article 96(1). 
2. Upon receipt of an application for appro val from an operator , the compet ent author ity shall, in accordance with 
Article 94(1) or point (a) of Article 95, make an on–sit e visit. 
3. Provided that the requirements refer red to in Article 97 and paragraphs (1) and (2) of this Article are fulfilled, the 
compet ent author ity shall grant the appro val. 
4. Where an establishment does not fulfil all requirements for appro val as refer red to in Article 97, the compet ent 
author ity may grant conditional appro val of an establishment if it appears, on the basis of the application by the 
operat or concer ned and the subsequent on–sit e visit as provided for in paragraph 2 of this Article, that the establishment 
meets all the main requirements that provide suffi cient guarantees that the establishment does not pose a signif icant 
risk. 
5. Where conditional appro val has been granted by the compet ent author ity in accordance with paragraph 4 of this 
Article, it shall grant full appro val only where it appears from another on–site visit to the establishment, carried out 
within three months of the date of the grant of conditional appro val, or from documentation provided by the operat or 
within three months from that date , that the establishment meets all the requirements for appro val provided for in 
Article 97(1) and the rules adopt ed pursuant to Article 97(2). 
Where the on–sit e visit or the documentation referred to in the first subparagraph shows that clear progress has been 
made but that the establishment still does not meet all of those requirements, the compet ent author ity may prolong the 
conditional appro val. However , conditional appro val shall not be grant ed for a period exceed ing, in total, six months. 
Article 100 
Review , suspension and withdrawal of appro vals by the competent author ity 
1. The compet ent author ity shall keep appro vals of establishments granted in accordance with Articles 97 and 99 
under review , at appropr iate inter vals based on the risk involved. 
2. Where a compet ent author ity identifies serious deficiencies in an establishment as regards compl iance with the 
requirements laid down in Article 97(1) and the rules adopt ed pursuant to Article 97(2), and the operat or of that 
establishment is not able to provide adequate guarant ees that those deficiencies will be eliminated, the compet ent 
author ity shall initiat e procedures to withdraw the appro val of the establishment. 
However , the compet ent author ity may merely suspend, rather than withdra w, appro val of an establishment where the 
operat or can guarant ee that it will eliminate those deficien cies within a reasonable period of time. 31.3.2016 L 84/79 Official Jour nal of the European Union EN     3. Appro val shall only be grant ed after withdrawal or restored after suspension in accordance with paragraph 2 when 
the compet ent author ity is satisfied that the establishment fully complies with all the requirements of this Regulation 
appropr iate for that type of establishment. 
Section 3 
Regist ers of the competent author ity 
Article 101 
Regis ters to be kept by the competent author ity 
1. Each compet ent author ity shall establish and keep up to date registers of: 
(a)  all establishments and operat ors registered with it pursuant to Article 93; 
(b)  all establishments appro ved by it in accordance with Articles 97 and 99. 
It shall make the registe rs refer red to in points (a) and (b) of the first subparagraph available to the Commission and to 
the compe tent author ities of other Member States in so far as the information contained therein is relevant for 
movements of kept terrestrial animals and germinal products thereof between Member States. 
It shall make the register of appro ved establishments as referred to in point (b) of the first subparagraph available to the 
public in so far as the information contained therein is relevant for movements of kept terrestr ial animals and germinal 
products thereof between Member States. 
2. Where appropr iate and relevant, a compet ent author ity may combine the registration refer red to in point (a) of the 
first subparagraph of paragraph 1 and the appro vals refer red to in point (b) of the first subparagraph of paragraph 1 
with registration for other purposes. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
detailed information to be included in the registers provided for in points (a) and (b) of the first subparagraph of 
paragraph 1, and the availabi lity to the public of the register provided for in point (b) of the first subparagraph of 
paragraph 1. 
Section 4 
Record-keeping 
Article 102 
Record-keepin g obligations of operators of establishments other than germinal products 
establishments 
1. Operato rs of establishments subject to the requirement of registration in accordance with Article 93, or appro val 
in accordance with Article 97(1), shall keep and maintain records containing at least the following information: 
(a)  the species, catego ries, number and, where applicable, identif ication of kept terrestrial animals on their 
establishment ; 
(b)  movements of kept terrestr ial animals into and out of their establishment, stating as appropr iate: 
(i)  their place of origin or destination; 
(ii)  the date of such movements; 
(c)  the documents required to accompan y kept terrestr ial animals arriving at or leav ing their establishment in 
accordance with point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of 
Article 115, point (b) of Article 117, Article 143(1) and (2), Article 164(2) and any rules adopt ed pursuant to 
Articles 118 and 120 and points (b) and (c) of Article 144(1); 
(d)  mor tality of kept terrestrial animals on their establishment ; 31.3.2016 L 84/80 Official Jour nal of the European Union EN     (e)  biosecur ity measures, surveillance, treatments, test results and other relevant information as appropr iate for: 
(i)  the species and catego ries of kept terrestrial animals in 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 25(1). 
The records shall be kept and maintained in paper or electronic form. 
2. Establishments presenting a low risk of spreading listed or emerging diseases may be exem pted by the Member 
State concer ned from the requirement to keep records of all or some of the information listed in paragraph 1. 
3. Operato rs of establishments shall keep the records provided for in paragraphs 1 and 2 on their establishment 
concer ned and shall: 
(a)  make them immediately available to the compet ent author ity on request ; 
(b)  retain them for a minimum period to be prescr ibed by the compet ent author ity, whic h may not be less than three 
years. 
4. By way of derogat ion from paragraph 3, operators may be exem pted from the oblig ation to keep records of some 
or all of the matte rs provided for in paragraph 1 when the operat or concer ned: 
(a)  has access to the comput erised database refer red to in Article 109 for the relevant species and the database already 
contains the information to be included in the records; and 
(b)  has the up–to–dat e information entered directly into the comput erised database. 
Article 103 
Record-keeping obligations of germinal product establishments 
1. Operato rs of germinal product establishments shall keep and maintain records containing at least the following 
information: 
(a)  the breed, age, identif ication and health status of donor animals used for the production of germinal products; 
(b)  the time and place of collection, and the processing and stora ge, of germinal products collect ed, produced or 
processed; 
(c)  the identif ication of the germinal products together with details of their place of destination, if kno wn; 
(d)  the documents required to accompan y germinal products arriving at or leav ing the establishment in question in 
accordance with Article 162 and Article 164(2) and any rules adop ted pursuant to Article 162(3) and (4); 
(e)  where relevant, the results of clinical and laboratory tests; 
(f)  laboratory techniques used. 
2. Establishments presenting a low risk of spreading listed or emerging diseases may be exem pted by the Member 
State concer ned from the requirement to keep records of all or some of the information listed in paragraph 1. 
3. Operato rs of germinal product establishments shall keep the records provided for in paragraphs 1 and 2 on their 
establishment and: 
(a)  make them immediately available to the compet ent author ity on request ; 
(b)  retain them for a minimum period to be prescr ibed by the compet ent author ity, whic h may not be less than three 
years. 31.3.2016 L 84/81 Official Jour nal of the European Union EN     Article 104 
Record-k eeping obligations of transpor ters 
1. Transpor ters shall keep and maintain records containing at least the following information: 
(a)  the establishments visited by them; 
(b)  the categor ies, species and number of kept terrestrial animals transpor ted by them; 
(c)  the cleaning, disinfection and disinf estation of the means of transpor t used; 
(d)  details of the documents accompan ying the animals in question, including their document numbers. 
The records shall be kept and maintained in paper or electronic form. 
2. Transpor ters presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State 
concer ned from the requirement to keep records of all or some of the information listed in paragraph 1. 
3. Transpor ters shall keep the records provided for in paragraphs 1 and 2: 
(a)  in such a manner that they can be made immediate ly available to the compet ent author ity on request ; 
(b)  for a minimum period to be prescr ibed by the compet ent author ity, which may not be less than three years. 
Article 105 
Record-kee ping obligations of operat ors conducting assembly operations 
1. Operato rs conducting assembly operations subject to the registration requirement laid down in Article 93 shall 
keep and maintain records containing at least the following information: 
(a)  the species, categor ies, numbers and identif ication of kept terrestr ial animals under their responsibility ; 
(b)  movements of kept terrestr ial animals under their responsibility , stating as appropr iate: 
(i)  their place of origin and destination; 
(ii)  the date of such movements; 
(c)  the documents required to accompan y kept terrestr ial animals moved under their responsibility in accordance with 
point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115, point (b) of 
Article 117, Article 143(1) and (2), Article 164(2) and any rules adopt ed pursuant to Articles 118 and 120 and 
points (b) and (c) of Article 144(1); 
(d)  mor tality of kept terrestrial animals under their responsibility ; and 
(e)  biosecur ity measures, surveillance, treatments, test results and other relevant information as appropr iate for the 
species and categor ies of kept terrestrial animals under their responsibility . 
The records shall be kept and maintained in paper or electronic form. 
2. Operato rs whose activities present a low risk of spreading listed or emerging diseases may be exem pted by the 
Member State concer ned from the requirement to keep records of all or some of the information listed in paragraph 1. 
3. Operato rs shall: 
(a)  make the records referred to in paragraph 1 available to the compe tent author ity on request ; 
(b)  retain those records for a minimum period to be prescr ibed by the compet ent author ity, whic h may not be less than 
three years. 31.3.2016 L 84/82 Official Jour nal of the European Union EN     Article 106 
Delegation of powers concer ning record-keeping 
1. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning rules 
supplementing the record-ke eping requirements provided for in Articles 102, 103, 104 and 105, as regar ds: 
(a)  information to be recorded in addition to that provided for in Articles 102(1), 103(1), 104(1) and 105(1); 
(b)  additional requirements for record-keeping in respect of germinal products collect ed, produced or processed in a 
germinal products establishment after that establishment ceased its activities. 
2. When establishing the rules to be laid down in delegat ed acts as provided for in paragraph 1, the Commission 
shall base those rules on the following matt ers: 
(a)  the risks posed by each type of establishment or activity ; 
(b)  the species and cate gories of kept terrestr ial animals or germinal products in the establishment concer ned, or 
transpor ted to or from that establishment ; 
(c)  the type of production on the establishment or the type of activity ; 
(d)  the typical movement patt erns and catego ries of the animals concer ned; 
(e)  the number of kept terrestrial animals or volume of germinal products under the responsibility of the operat or 
concer ned. 
Article 107 
Implementing powers concer ning exemp tions from the record-keepin g requirements 
The Commission may, by means of implementing acts, lay down rules concer ning the types of establishments and 
operat ors that may be exem pted by Member States from the record-kee ping requirements provided for in Articles 102, 
103, 104 and 105, as regards: 
(a)  establishments keeping, or operat ors handling or transpor ting, a small number of kept terrestrial animals or a small 
volume or number of germinal products; 
(b)  species or catego ries of kept terrestrial animals or germinal products. 
When adopt ing those imple menting acts, the Commission shall base those acts on the criteria laid down in 
Article 106(2). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 2 
Traceability requir ements for kept terrestr ial animals and germinal produ cts 
Section 1 
Kept ter restr ial animals 
Article 108 
Member States' responsibility for establishing a system for the identif ication and registration of 
kept terrestr ial animals 
1. Member State s shall have in place a system for the identification and registration of those species of kept terrestrial 
animals for which such a system is required by this Regulation and by any rules adopt ed pursuant to it. Such a system 
shall, when appropr iate, provide for the recording of the movements of such animals. 31.3.2016 L 84/83 Official Jour nal of the European Union EN     2. When establishing the system referred to in paragraph 1, Member States shall take into account: 
(a)  the species or catego ries of kept terrestrial animals concer ned; 
(b)  the risk posed by that species or cate gory. 
3. 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)  identif ication documents, movement documents and other documents for identifying and tracing kept terrestrial 
animals as referred to in Article 110; 
(c)  up–t o–date records in establishments as provided for in points (a) and (b) of Article 102(1); 
(d)  a comput er database of kept terrestrial animals as provided for in Article 109(1). 
4. The system provided for in paragraph 1 shall be designed in such 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 entr y into the Union; 
(c)  ensures the efficient inter operability , integration and compat ibility of the elements of that system; 
(d)  ensures that the system, to the extent appropr iate, is adapt ed to: 
(i)  the comput erised information system for Union notification and repor ting provided for in Article 22; 
(ii)  TRA CES; 
(e)  ensures a coherent approach in respect of the different animal species covered by the system. 
5. Member States may when appropr iate: 
(a)  use the whole or part of the system provided for in paragraph 1 for purposes other than those refer red to in 
points (a) and (b) of paragraph 4; 
(b)  integrat e the identif ication documents, movement documents and other documents referred to in Article 110 with 
the animal health certificates or self–declaration document provided for in Article 143(1) and (2) and Article 151(1) 
and in any rules adopt ed pursuant to points (b) and (c) of Article 144(1) and Article 151(3) and (4); 
(c)  designate another author ity or author ise another body or a natural person to ensure the practical application of the 
identif ication and registration system provided for in paragraph 1 of this Article, including the issuing of identif i­
cation documents and the drawing-up of models as provided for in points (a), (b) and (c) of Article 110(1). 
Article 109 
Member States' obligation to establish and maintain a computer database of kept terrest rial 
animals 
1. The Member States shall establish and maintain a comput er database for the recording of at least: 
(a)  the following information related to kept animals of the bovine species: 
(i)  their individual identif ication as provided for in point (a) of Article 112; 
(ii)  the establishments keeping them; 
(iii)  their movements into and from those establishments; 31.3.2016 L 84/84 Official Jour nal of the European Union EN     (b)  the following information related to kept animals of the ovine and capr ine species: 
(i)  information on their identif ication as provided for in point (a) of Article 113(1) and the number of animals at 
the establishments keeping them; 
(ii)  the establishments keeping them; 
(iii)  their movements into and from those establishments; 
(c)  the following information related to kept animals of the porcine species: 
(i)  information on their identif ication as provided for in Article 115 and the number of animals at the 
establishments keeping them; 
(ii)  the establishments keeping them; 
(iii)  their movements into and from those establishments; 
(d)  the following information related to kept animals of the equine species: 
(i)  their unique code as provided for in Article 114; 
(ii)  the method of identif ication provided for in point (b) of Article 114(1) linking the animal concer ned with the 
identification document refer red to in point (iii) where relevant ; 
(iii)  the relevant identification details from the identif ication document provided for in point (c) of Article 114(1), as 
determined in the rules adopt ed pursuant to Articles 118 and 120; 
(iv)  the establishments where those animals are habitually kept; 
(e)  information relat ed to kept terrestrial animals of species other than those referred to in points (a), (b), (c) and (d) of 
this paragraph, when this is provided for in the rules adopt ed pursuant to paragraph 2. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
recording of information related to animal species other than those referred to in points (a), (b), (c) and (d) of 
paragraph 1 of this Article in the comput er database provided for in that paragraph where necessar y, due to the specifi c 
and significant risks posed by those species, in order to: 
(a)  ensure the efficient application of the disease prevention measures and control measures provided for in this 
Regulation; 
(b)  facilitate the traceability of kept terrestr ial animals, their movements between Member States and their entr y into the 
Union. 
Article 110 
Obligation of the competent author ity in respect of identif ication documents, movement 
documents and other documents for the identif ication and tracing of kept terrest rial animals 
1. Each compet ent author ity shall: 
(a)  issue identif ication documents in respect of kept terrestr ial animals where those documents are required by point (c) 
of Article 114(1) and point (b) of Article 117 and by rules adopt ed pursuant to Articles 118 and 120; 
(b)  issue identif ication documents in respect of bovine animals as required by point (b) of Article 112, unless Member 
State s exchange electronic data with other Member State s within the framewor k of an electronic exchange system 
from the date when the Commission recognises the full operability of that system ; 
(c)  draw up models of movement documents and other documents for the identif ication and tracing of kept terrestrial 
animals, when required by point (b) of Article 113(1), point (b) of Article 115, point (b) of Article 117 and any 
rules adopt ed pursuant to Articles 118 and 120. 31.3.2016 L 84/85 Official Jour nal of the European Union EN     2. Point (b) of paragraph (1) is without prejudice to the right of Member States to adopt national rules on the issuing 
of passpor ts for animals not intended for movement between Member State s. 
Article 111 
Public availability of information on means of identif ication 
Each compet ent author ity shall inform the Commission of, and make publicly available, information on: 
(a)  contact points for the comput er databases established by the Member States in accordance with Article 109(1); 
(b)  the author ities or bodies responsible for issuing identif ication documents, movement documents and other 
documents in accordance with Article 110, taking into account point (c) of Article 108(5); 
(c)  the means of identif ication that are to be used for each species and categor y of kept terrestr ial animals in accordance 
with point (a) of Article 112, point (a) of Article 113(1), Article 114(1), point (a) of Article 115, point (a) of 
Article 117 and any rules adopt ed pursuant to Articles 118 and 120; 
(d)  the prescr ibed format for the issuing of the identification documents and other documents refer red to in 
Article 110. 
Article 112 
Operat ors' obligations in respect of the identif ication of kept animals of the bovine species 
Operato rs keeping animals of the bovine species shall: 
(a)  ensure that those kept animals are identif ied individually by a physical means of identif ication; 
(b)  ensure that those kept animals, when they are moved between Member States, are issued with an identification 
document from the compet ent author ity or designat ed author ity or author ised body of origin, unless the conditions 
laid down in point (b) of Article 110(1) are met ; 
(c)  ensure that that identif ication document : 
(i)  is kept, correctly compl eted and update d by the operator concer ned; and 
(ii)  accompanies those kept terrestrial animals at the time of movement, when such document is required by 
point (b); 
(d)  transmit the information on movements of those kept animals from and to the establishment concer ned, and all 
births and deaths in that establishment, to the comput er database provided for in Article 109(1). 
Article 113 
Operato rs' obligations in respect of the identif ication of kept animals of the ovine and capr ine 
species 
1. Operato rs keeping kept animals of the ovine and capr ine species shall: 
(a)  ensure that those kept animals are each identified by a physical means of identif ication; 
(b)  ensure that those kept animals are accompan ied by a correctly compl eted movement document based on the model 
drawn up by the compet ent author ity in accordance with Article 110 when they are moved from the establishment 
keepin g those animals within the Member State concer ned; 31.3.2016 L 84/86 Official Jour nal of the European Union EN     (c)  transmit the information on movements of those kept animals from and to the establishment to the comput er 
database provided for in Article 109(1). 
2. Member States may exempt operat ors from the requirement to ensure that kept animals of the ovine and capr ine 
species are accompanied by movement documents during movements within their territory , provided that: 
(a)  the information contained in the relevant movement document is included in the comput er database provided for in 
Article 109(1); 
(b)  the system for the identif ication and registration of kept animals of the ovine and capr ine species provides level of 
traceability equivalent to that provided by movement documents. 
Article 114 
Operato rs' obligations in respect of the identif ication and regis tration of kept animals of the 
equine species 
1. Operato rs keeping kept animals of the equine species shall ensure that those animals are individually identified by: 
(a)  a unique code which is recorded in the comput er database provided for in Article 109(1); 
(b)  a physical means of identification or other method which unequivocally link s the kept animal with the identif ication 
document provided for in point (c) of this paragraph and issued by the compe tent author ity in accordance with 
Article 110; 
(c)  a correctly compl eted sing le lifetime identif ication document. 
2. Operato rs of kept animals of the equine species shall ensure that the information on those animals is transmitted 
to the comput er database provided for in Article 109(1). 
Article 115 
Operato rs' obligations in respect of the identif ication and regis tration of kept animals of the 
porcine species 
Operato rs keeping kept animals of the porcine species shall: 
(a)  ensure that those kept animals are each identified by a physical means of identif ication; 
(b)  ensure that those kept animals are accompan ied by a correctly compl eted movement document based on the model 
drawn up by the compet ent author ity in accordance with point (b) of Article 110(1) when they are moved from the 
establishment keepin g those animals within the Member State concer ned; 
(c)  transmit the information relating to the establishment keeping those animals to the comput er database provided for 
in Article 109(1). 
Article 116 
Derogations concer ning movements of kept animals of the porcine species 
By way of derogation from point (b) of Article 115, Member States may exempt operat ors from the requirement to 
ensure that kept animals of the porcine species are accompanied by correctly complet ed movement documents based on 
the model drawn up by the compet ent author ity for movements within the Member State concer ned, provided that: 
(a)  the information contained in such movement documents is included in the comput er database established by that 
Member State in accordance with Article 109(1); 
(b)  the system for the identif ication and registration of kept terrestrial animals of the porcine species provides a level of 
traceability equivalent to that provided by such movement documents. 31.3.2016 L 84/87 Official Jour nal of the European Union EN     Article 117 
Operato rs' obligation in respect of the identif ication of kept terrest rial animals other than animals 
of the bovine, ovine, capr ine, porcine and equine species 
Operato rs shall ensure that kept terrestrial animals of species other than those of the bovine, ovine, capr ine, porcine and 
equine species fulfil the following requirements, when required by the rules adop ted pursuant to Articles 118 and 120: 
(a)  they are identified, either individually or in groups; 
(b)  they are accompan ied by correctly compl eted and update d identif ication documents, movement documents or other 
documents for the identif ication and tracing of animals, as appropr iate for the animal species concer ned. 
Article 118 
Delegation of powers concer ning identif ication and registration 
1. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  detailed requirements for the means and methods of identification of kept terrestr ial animals provided for in 
point (a) of Article 112, point (a) of Article 113(1), Article 114(1), point (a) of Article 115 and point (a) of 
Article 117, including their application and use; 
(b)  rules on the information to be included in: 
(i)  the comput er databases provided for in points (a) to (d) of Article 109(1); 
(ii)  the identification and movement documents provided for in point (b) of Article 112, point (b) of Article 113(1), 
point (c) of Article 114(1), and point (b) of Article 115; 
(c)  rules on the exchang e of electronic data between comput er databases of Member State s as refer red to in point (b) of 
Article 110(1). 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  detailed requirements for alternati ve means and methods of identification to those refer red to in point (a) of 
paragraph 1 of this Article, as well as exem ptions and special provisions for certain categor ies of animals or circum ­
stances and conditions for such exem ptions; 
(b)  specifi c provisions for the identif ication or movement documents provided for in point (b) of Article 112, point (b) 
of Article 113(1), point (c) of Article 114(1), point (b) of Article 115 and point (b) of Article 117 that have to 
accompan y animals when they are moved; 
(c)  detailed requirements for the identif ication and registration of kept terrestr ial animals of species other than the 
bovine, ovine, capr ine, porcine and equine species where necessar y, taking into account the risks posed by the 
species concer ned, in order to: 
(i)  ensure the efficient application of the disease prevention and control measures provided for in this Regulation; 
(ii)  facilitat e the traceability of kept terrestr ial animals, and their movements within and between Member States and 
their entr y into the Union; 
(d)  rules on the information to be included in: 
(i)  the comput er databases provided for in point (e) of Article 109(1); 
(ii)  the identif ication and movement documents provided for in point (b) of Article 117; 
(e)  rules on the identif ication and registration of kept terrestr ial animals as referred to in Articles 112 to 117 after their 
entr y into the Union. 31.3.2016 L 84/88 Official Jour nal of the European Union EN     3. When establishing the rules to be laid down in the deleg ated acts provided for in this Article, the Commission 
shall base those rules on the considerations provided for in Article 119(2). 
Article 119 
Delegation of powers concer ning derogations from the traceability requirements 
1. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
derogat ions for operat ors from the identification and registration requirements provided for in Articles 112, 113, 114 
and 115: 
(a)  in cases where one or more of the elements listed in Article 108(3) are not necessar y in order to meet the 
requirements provided for in points (a) and (b) of Article 108(4); and 
(b)  when other traceability measures in place in the Member States guarantee that the level of traceability of the animals 
in question is not compr omised, 
as well as transitional measures required for the practical application of such derogations . 
2. When establishing the rules to be laid down in the delegat ed acts provided for in paragraph 1, the Commission 
shall base those rules on the following considerations: 
(a)  the species and categor ies of kept terrestrial animals concer ned; 
(b)  the risks involved for those kept terrestrial animals; 
(c)  the number of animals in the establishments concer ned; 
(d)  the type of production in the establishments where those terrestrial animals are kept; 
(e)  movement patter ns for the species and cate gories of kept terrestr ial animals concer ned; 
(f)  considerations concer ning the prot ection and conser vation of the species of kept terrestrial animals concer ned; 
(g)  the performa nce of the other traceability elements of the system for the identif ication and registration of kept 
terrestrial animals referred to in Article 108(3). 
Article 120 
Implementing powers concer ning the traceability of kept terrest rial animals 
1. The Commission shall, by means of implemen ting acts, adopt rules: 
(a)  for unif orm access to data contained in, and the technical specifications and operational rules of, the comput er 
databases refer red to in points (a) to (d) of Article 109(1); 
(b)  on the technical conditions and modalities for the exchang e of electronic data between comput er databases of 
Member States and the recognition of full operability of the data exchange syste ms refer red to in point (b) of 
Article 110(1). 
2. The Commission may, by means of imp lementing acts, adop t rules: 
(a)  for the unif orm application of the identif ication and registration system provided for in Article 108(1) for different 
species or catego ries of kept terrestr ial animals, in order to ensure its efficient operation; 
(b)  for the unif orm application of point (c) of Article 108(5) concer ning the author ised bodies or natural persons 
refer red to in Article 108(5) and the conditions for their designation; 
(c)  on the technical specifications and procedures, formats, design and operational rules for the means and methods of 
identif ication, including: 
(i)  the time periods for the application of the means and methods of identif ication; 31.3.2016 L 84/89 Official Jour nal of the European Union EN     (ii)  the remo val, modifi cation or replacement of the means and methods of identif ication and the deadlines for such 
operations; and 
(iii)  the configuration of the identif ication code; 
(d)  on the technical specifi cations, formats and operational rules for the identification and movement documents 
provided for in point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of 
Article 115 and point (b) of Article 117; 
(e)  for unif orm access to data contained in, and the technical specific ations and operational rules of, the comput er 
databases refer red to in point (e) of Article 109(1); 
(f)  on the deadlines, oblig ations and procedures for the transmission of information by operat ors or other natural or 
lega l persons and for the registration of kept terrestr ial animals in the comput er databases; 
(g)  on guidelines and procedures for electronic identif ication of animals, where relevant ; 
(h)  on the practical application of exemptions from the identification and registration requirements provided for in the 
rules adop ted pursuant to Article 119(1). 
3. The implementing acts referred to in this Article shall be adopt ed in accordance with the examination procedure 
referred to in Article 266(2). 
Section 2 
Ger minal products 
Article 121 
Traceability requirements for germinal products of kept animals of the bovine, ovine, capr ine, 
porcine and equine species 
1. Operato rs producing, processing or storing germinal products shall mark germinal products of kept animals of the 
bovine, capr ine, ovine, porcine and equine species in such a way that they can be clearly traced to: 
(a)  the donor animals; 
(b)  the date of collection; and 
(c)  the germinal product establishments where they were collect ed, produced, processed and store d. 
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, their movements within and between Member State s and their entr y into 
the Union. 
Article 122 
Delegation of powers concer ning traceability requirements for germinal products 
1. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning traceability requirements 
for germinal products of kept terrestr ial animals of the bovine, capr ine, ovine, porcine and equine species supplementing 
the rules laid down in Article 121; 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
traceability requirements for germinal products of kept terrestrial animals of species other than of the bovine, capr ine, 
ovine, porcine and equine species, where necessar y for: 
(a)  the efficient application of the disease prevention and control measures provided for in this Regulation; 31.3.2016 L 84/90 Official Jour nal of the European Union EN     (b)  the traceability of those germinal products, their movements within and between Member States and their entr y into 
the Union. 
3. When adopting the delega ted acts provided for in paragraph 1, the Commission shall base those acts on the 
following matt ers: 
(a)  the species of kept terrestrial animals from whic h 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, production, processing or stora ge of germinal products; 
(f)  the movement patter ns for the relevant species and categor ies of kept terrestrial animals and their germinal 
products; 
(g)  considerations concer ning the protection and conser vation of species of kept terrestr ial animals; 
(h)  other elements that may contr ibute to the traceability of germinal products. 
Article 123 
Implementing powers concer ning traceability requirements for germinal products 
The Commission shall, by means of implementing acts, lay down rules concer ning: 
(a)  technical requirements and specifications for marking as provided for in Article 121(1); 
(b)  operational requirements for the traceability provided for in delegat ed acts adop ted pursuant to Article 122(1). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 3 
Movements within the Union of kept terrestr ial animals 
Section 1 
General requirements for mo vements 
Article 124 
General requirements for movements of kept terrest rial animals 
1. Operato rs shall take appropr iate preventive measures to ensure that the movement of kept terrestr ial animals does 
not jeopardise the health status at the place of destination with regard to: 
(a)  the liste d diseases referred to in point (d) of Article 9(1); 
(b)  emerging diseases. 
2. Operato rs shall only move kept terrestrial animals from their establishments and receive such animals if the 
animals in question fulfil the following conditions: 
(a)  they come from establishments that have been: 
(i)  register ed by the compet ent author ity in accordance with Article 93; or 31.3.2016 L 84/91 Official Jour nal of the European Union EN     (ii)  appro ved by the compet ent author ity in accordance with Articles 97(1) and 98, when required by Article 94(1) 
or Article 95; or 
(iii)  grant ed a derogation from the registration requirement laid down in Article 84; 
(b)  they fulfil the identif ication and registration requirements laid down in Articles 112, 113, 114, 115 and 117 and the 
rules adopt ed pursuant to Articles 118 and 120. 
Article 125 
Disease prev ention measures in relation to transpor t 
1. Operato rs shall take the appropr iate and necessar y preventive measures to ensure that: 
(a)  the health status of kept terrestr ial animals is not jeopardised during transpor t; 
(b)  transpor t operations of kept terrestr ial animals do not cause the poten tial spread of listed diseases as refer red to in 
point (d) of Article 9(1) to humans and animals; 
(c)  cleaning and disinfection of, and control of insects and rodents with respect to, equipment and means of transpor t 
and other adequate biosecur ity measures are taken, as appropr iate to the risks involved with the transpor t 
operations concer ned. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the conditions and requirements for cleaning and disinf ection of, and control of insects and rodents with respect to, 
equipment and means of transpor t and the use of biocidal products for those purposes; 
(b)  other appropr iate biosecur ity measures as provided for in point (c) of paragraph 1 of this Article. 
Section 2 
Mo vements betw een Member Sta tes 
Article 126 
General requirements for movements of kept terrestr ial animals betw een Member States 
1. Operato rs shall only move kept terrestr ial animals to another Member State if the animals in question fulfil the 
following conditions: 
(a)  they show no disease symp toms; 
(b)  they come from a register ed or appro ved establishment: 
(i)  where there are no abnor mal mor talities with an undeterm ined cause; 
(ii)  whic h is not subject to movement restr ictions affecting the species to be moved in accordance with the rules 
laid down in Article 55(1), point (a) of Article 61(1), Article 62, point (c) of Article 65(1), Article 74(1) and 
Article 79 and the rules adopt ed pursuant to Article 55(2), Articles 63 and 67, Articles 71(3), 74(4), and 83(2) 
or the emergency measures provided for in Articles 257 and 258 and any rules adopt ed pursuant to 
Article 259, unless derogations from movement restr ictions have been granted in accordance with those rules; 
(iii)  whic h is not situated in a restr icted zone in accordance with rules laid down in point (f)(ii) of Article 55(1), 
Articles 64 and 65, Article 74(1), Article 79 and any rules adopt ed pursuant to Article 67, Article 71(3), 
Article 74(4) and Article 83(2) or the emergency measures provided for in Articles 257 and 258 and any rules 
adopt ed pursuant to Article 259, unless derog ations have been grant ed in accordance with those rules; 31.3.2016 L 84/92 Official Jour nal of the European Union EN     (c)  they have not been in contact with kept terrestr ial animals which are subject to movement restr ictions as refer red to 
in point (b)(ii) and (iii) or kept terrestrial animals of a liste d 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 liste d diseases and emerging diseases in question; 
(ii)  the type of establishment concer ned; 
(iii)  the species and catego ry of kept terrestr ial animals moved; 
(iv)  other epidemiological factors; 
(d)  they fulfil the relevant requirements provided for in Sections 3 to 8 (Articles 130 to 154). 
2. Operato rs shall take all necessar y measures to ensure that kept terrestr ial animals moved to another Member State 
are consigned directly to their place of destination in that other Member State unless they need to stop at a place of 
resting for animal welf are reasons. 
Article 127 
Obligations of operat ors at the place of destination 
1. Operato rs of establishments and slaughter houses receiving kept terrestrial animals from another Member State 
shall: 
(a)  check that: 
(i)  the means or methods of identif ication provided for in point (a) of Article 112, point (a) of Article 113(1), 
points (a) and (b) Article 114(1), point (a) of Article 115 and point (a) of Article 117 and the rules adopt ed 
pursuant to Articles 118 and 120 are in place; 
(ii)  the identification documents provided for in point (b) of Article 112, point (b) of Article 113(1), point (c) of 
Article 114(1), point (b) of Article 117 and the rules adopt ed pursuant to Articles 118 and 120 are in place and 
are correctly compl eted; 
(b)  check that the animal health certificates provided for in Article 143 and in any rules adopt ed pursuant to points (b) 
and (c) of Article 144(1) or the self–declaration documents provided for in Article 151 and the rules adopt ed 
pursuant to Article 151(3) and (4) are in place; 
(c)  inform the compet ent author ity of the place of destination, after chec king the kept terrestrial animals received, of 
any irregular ity with regar d to: 
(i)  the kept terrestr ial animals received; 
(ii)  the means or methods of identification referred to in point (a)(i); 
(iii)  the documents refer red to in points (a)(ii) and (b). 
2. In the event of any irregular ity as referred to in point (c) of paragraph 1, the operat or shall isolate the animals 
concer ned by that irregular ity until the compet ent author ity of the place of destination has take n a decision regarding 
them. 
Article 128 
Prohibition on movements of kept terrestr ial animals for disease eradication pur poses outside the 
territor y of a Member State 
Operato rs shall not move kept terrestrial animals intended to be slaughtered for disease eradication purposes as part of 
an eradication programme, as provided for in Article 31(1) or (2), to another Member State unless the Member State of 
destination and, where relevant, the Member State of passage author ise the movement in advance. 31.3.2016 L 84/93 Official Jour nal of the European Union EN     Article 129 
General requirement applicable to operat ors in respect of movements of kept terrestrial animals 
passing through Member States but intended for expor t from the Union to third countr ies or 
territories 
Operato rs shall ensure that kept terrestrial animals intende d for expor t to a third countr y or territory and passing 
through the territory of another Member State fulfil the requirements laid down in Articles 124, 125, 126 and 128. 
Section 3 
Specif ic requirements in respect of mo vements to other Member Sta tes of 
ungulates and poultr y 
Article 130 
Movements of kept ungulates and poultr y to other Member States 
Operato rs shall only move kept ungulates and poultr y from an establishment in one Member State to another Member 
State if the animals in question fulfil the following conditions as regar ds the listed diseases refer red to in point (d) of 
Article 9(1): 
(a)  they show no clinical symp toms or signs of liste d diseases as referred to in point (d) of Article 9(1) at the time of 
movement ; 
(b)  they have been subject to a residency period appropr iate to those liste d diseases, taking into account the species and 
catego ry of kept ungulates and poultr y to be moved; 
(c)  for a period of time appropr iate for those listed diseases and the species and catego ry of ungulate s or poultr y to be 
moved, no kept ungulates or poultr y have been introduced into the establishment of origin when a requirement to 
that effect is laid down in the rules adopt ed in accordance with Article 131 or Article 135; 
(d)  they are presumed not to pose a signif icant risk of spreading of those listed diseases at the place of destination, 
based on: 
(i)  the health status concer ning relevant diseases for species or catego ries of kept ungulates and poultr y moved, 
taking into account the health status at the place of destination; 
(ii)  the results of laborat ory or other examinations necessar y in order to provide guarant ees regarding the health 
status required for the movement in question; 
(iii)  the application of vaccination or other disease prevention or risk-mitig ation measures aimed at limiting the 
spread of the relevant disease to the places of destination or passage . 
Article 131 
Delegation of powers in respect of movements of kept ungulates and poultr y to other Member 
States 
1. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  residency periods as referred to in point (b) of Article 130; 
(b)  the period of time necessar y in order to limit the introduction of kept ungulates or poultr y into establishments prior 
to movement as provided for in point (c) of Article 130; 31.3.2016 L 84/94 Official Jour nal of the European Union EN     (c)  supplementar y requirements to ensure that kept ungulates and poultr y do not pose a signif icant risk for the spread 
of listed diseases as referred to in point (d) of Article 9(1), as provided for in point (d) of Article 130); 
(d)  other necessar y risk-mitigation measures supplementing the requirements laid down in Article 130. 
2. When establishing the rules to be laid down in the delegat ed acts provided for in paragraph 1, the Commission 
shall base those rules on the following considerations: 
(a)  the listed diseases referred to in point (d) of Article 9(1) relevant for the listed species or the catego ry of kept 
ungulates or poultr y to be moved; 
(b)  the health status as regards listed diseases referred to in point (d) of Article 9(1) in the establishments, 
compar tments, zones and Member States of origin and destination; 
(c)  the type of establishment concer ned and the type of production at the places of origin and destination; 
(d)  the type of movement concer ned; 
(e)  the species and categor ies of kept ungulates or poultr y to be moved; 
(f)  the age of the kept ungulate s or poultr y to be moved; 
(g)  other epidemiological factors. 
Article 132 
Kept ungulates and poultr y moved to another Member State and intended for slaughter 
1. Operato rs of slaughter houses receiving kept ungulates and poultr y 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 
delegat ed acts adopt ed pursuant to paragraph 2. 
2. The Commission shall adop t delegat ed acts in accordance with Article 264 concer ning the time of slaughter 
provided for in paragraph 1 of this Article. 
Section 4 
Assembly operations in respect of kept ungulates and poultr y 
Article 133 
Derogation in respect of assembly operations 
1. By way of deroga tion from Article 126(2), operators may subject kept ungulate s and poultr y to a maximum of 
three assembly operations during a movement from a Member State of origin to another Member State. 
2. The assembly operations provided for in paragraph 1 of this Article shall only take place in an establishment 
appro ved for that purpose in accordance with Article 97(1) and Article 99(3) and (4). 
However , the Member State of origin may allow an assembly operation on its territory to take place on a means of 
transpor t, collecting kept ungulates or poultr y directly from their establishments of origin, provided that those animals 
are not unloaded again during that operation and before arriving: 
(a)  at the establishment or final place of destination; or 
(b)  for the subsequent assembly operation in an establishment appro ved for that purpose in accordance with 
Article 97(1) and Article 99(4) and (5). 31.3.2016 L 84/95 Official Jour nal of the European Union EN     Article 134 
Disease prev ention requirements in respect of assembly operations 
Operato rs conducting assembly operations shall ensure that: 
(a)  the kept ungulates and poultr y assembled have the same health status; where they do not, the lower health status 
applies to all such animals assembled; 
(b)  the kept ungulates and poultr y are assembled and moved to their final place of destination in another Member State 
as soon as possible after leav ing their establishment of origin, and at the latest within a timeframe to be laid down in 
delegat ed acts adop ted pursuant to point (c) of Article 135; 
(c)  the necessar y biosecur ity measures are taken to ensure that the kept ungulate s and poultr y assembled: 
(i)  do not come into contact with kept ungulates or poultr y having a lower health status; 
(ii)  do not pose a signif icant risk for the spread of the listed diseases refer red to in point (d) of Article 9(1) to the 
kept ungulates or poultr y at the place where the assembly operation takes place; 
(d)  the kept ungulate s and poultr y are identified where so required by this Regulation and are accompanied by the 
following documents: 
(i)  the identif ication and movement documents as provided for in point (b) of Article 112, point (b) of 
Article 113(1), point (c) of Article 114(1), point (b) of Article 115 and point (b) of Article 117 and any rules 
adopt ed pursuant to Articles 118 and 120, unless derogations are provided for in accordance with 
Articles 113(2) and 119; 
(ii)  the animal health certificates as provided for in Article 143 and point (c) of Article 144(1), unless derog ations 
are provided for in the rules adopt ed pursuant to point (a) of Article 144(1); 
(iii)  the self–declaration document as provided for in Article 151. 
Article 135 
Delegation of powers concer ning assembly operations 
The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  specifi c rules for assembly operations, where other risk-mitig ation measures, in addition to those provided for in 
points (b) and (c) of Article 134, are in place; 
(b)  criteria under whic h Member States of origin may allow assembly operations to take place on means of transpor t, as 
provided for in the second subparagraph of Article 133(2); 
(c)  the timeframe between the time of depar ture of the kept ungulates or poultr y from their establishment of origin and 
their depar ture from the assembly operation to their final destination in another Member State, as refer red to in 
point (b) of Article 134; 
(d)  detailed rules as regards the biosecur ity measures provided for in point (c) of Article 134. 
Section 5 
Mo vements to other Member State s of kept ter rest rial animals other than kept 
ungulates and poultr y 
Article 136 
Movements of kept terrest rial animals other than kept ungulates and poultr y to other Member 
States and delegated acts 
1. Operato rs shall only move kept terrestrial animals other than kept ungulate s or poultr y from an establishment in 
one Member State to another Member State if the animals in question do not pose a signif icant risk for the spread of 
listed diseases as referred to in point (d) of Article 9(1) at the place of destination. 31.3.2016 L 84/96 Official Jour nal of the European Union EN     2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning detailed 
rules to ensure that kept terrestrial animals other than kept ungulates or poultr y do not pose a significant risk for the 
spread of liste d diseases as refer red to in point (d) of Article 9(1), as provided for in paragraph 1 of this Article. 
3. When establishing the detailed rules to be laid down in the delegat ed acts provided for in paragraph 2, the 
Commission shall base those rules on the following considerations: 
(a)  the listed diseases referred to in point (d) of Article 9(1) relevant for the listed species or the catego ry of kept 
terrestrial animals to be moved; 
(b)  the health status as regar ds the listed diseases referred to in point (d) of Article 9(1) in the establishments, 
compar tments, 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 the place of destination; 
(e)  the species and categor ies of kept terrestrial animals to be moved; 
(f)  the age of the kept terrestr ial animals to be moved; 
(g)  other epidemiological factors. 
Section 6 
DErogating from, and supplementing, risk-mitigation measures for mo vements of 
kept ter rest rial animals 
Article 137 
Kept terrestrial animals intended for conf ined establishments and delegated acts 
1. Operato rs shall only move kept terrestrial animals to a conf ined establishment if the animals in question fulfil the 
following conditions: 
(a)  they originate from another confined establishment ; 
(b)  they do not pose a significant risk for the spread of liste d diseases as referred to in point (d) of Article 9(1) to listed 
species or to catego ries of animals at the conf ined establishment of destination, excep t where the movement in 
question is author ised for scientifi c purposes. 
2. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  detailed rules for movements of kept terrestr ial animals into confined establishments in addition to those provided 
for in paragraph 1 of this Article; 
(b)  specifi c rules for movements of kept terrestr ial animals into conf ined establishments where the risk-mitig ation 
measures in place guarant ee that such movements do not pose a signif icant risk for the health of kept terrestrial 
animals within that conf ined establishment and the surrounding establishments. 
Article 138 
Movements of kept terrest rial animals for scientif ic pur poses and delegated acts 
1. The compet ent author ity of the place of destination may, subject to the agreement of the compet ent author ity of 
the place of origin, author ise movements of kept terrestrial animals into the territory of the Member State of destination, 
for scientifi c purposes, where those movements do not comply with the requirements of Sections 1 to 5 (Articles 124 
to 136), with the excep tion of Articles 124 and 125, point (b)(ii) of Article 126(1) and Article 127. 31.3.2016 L 84/97 Official Jour nal of the European Union EN     2. The compet ent author ity of the place of destination shall only grant derog ations as provided for in paragraph 1 
under the following conditions: 
(a)  the compet ent author ities of the places of destination and origin: 
(i)  have agreed on the conditions for such movements; 
(ii)  ensure that the necessar y risk-mitig ation measures are in place so that those movements do not jeopardise the 
health status in places en rout e and in the place of destination with regar d to the listed diseases referred to in 
point (d) of Article 9(1); and 
(iii)  have notified , where relevant, the compet ent author ities of the Member States of passage of the derog ation 
grant ed and of the conditions under whic h it is grant ed; and 
(b)  those movements of those animals take place under the super vision of the compet ent author ities of the places of 
origin and destination, and where relevant, the compe tent author ities of the Member States of passage . 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning rules for 
the granting of derogat ions by compet ent author ities, supplementing those provided for in paragraphs 1 and 2 of this 
Article. 
Article 139 
Derogations concer ning recreational use, spor ting and cultural events, work near borders and 
grazing 
1. The compet ent author ity of the place of destination may grant derogat ions from the requirements of Sections 2 
to 5 (Articles 126 to 136), with the excep tion of points (a),(b) and (c) of Article 126(1) and Articles 127 and 128, for 
intra–Un ion movements of kept terrestr ial animals between Member States where such movements are for: 
(a)  recreational use near borders; 
(b)  exhibitions, and spor ting, cultural and similar events, organised near borders; 
(c)  grazing of kept terrestr ial animals in grazing areas shared between Member States; or 
(d)  work done by kept terrestrial animals near borders of Member State s. 
2. Derog ations by the compet ent author ity 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 
appropr iate risk-mitig ation measures shall be take n to ensure that such movements do not pose a signif icant risk. 
3. The Member States referred to in paragraph 2 shall inform the Commission of the granting of derogat ions as 
provided for in paragraph 1. 
4. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning rules for 
the granting of derog ations by the compet ent author ity of the place of destination, supplementing those provided for in 
paragraph 1 of this Article. 
Article 140 
Delegation of power concer ning circuses, exhibitions, spor ting events and recreational use, zoos, 
pet shops, animal shelters and wholesalers 
The Commission shall be empo wered to adopt delega ted acts in accordance with Article 264 concer ning: 
(a)  specifi c requirements supplementing the rules laid down in Sections 2 to 5 (Articles 126 to 136) for movements of 
kept terrestr ial animals for the following purposes: 
(i)  circuses, zoos, pet shops, animal shelt ers and wholesalers; 
(ii)  exhibitions and spor ting, cultural and similar events; 31.3.2016 L 84/98 Official Jour nal of the European Union EN     (b)  derogations from Sections 2 to 5 (Articles 126 to 136), with the excep tion of points (a), (b) and (c) of Article 126(1) 
and Articles 127 and 128, for movements of kept terrestr ial animals as refer red to in point (a) of this Article. 
Article 141 
Implementing power to adopt temporar y rules for movements of specif ic species or categor ies of 
kept terrestr ial animals 
1. The Commission may, by means of implementing acts, lay down temporar y rules, by way of addition or alternati ve 
to those laid down in this Chapt er, for movements of specif ic species or catego ries of kept terrestr ial animals where: 
(a)  the movement requirements provided for in Article 130, Article 132(1), Articles 133 and 134, Articles 136(1), 
137(1) and 138(1) and (2) and Article 139 and the rules adopt ed pursuant to Articles 131(1) and 132(2), 
Article 135, Articles 136(2), 137(2), 138(3) and 139(4) and Article 140 are not effectively mitig ating the risks 
posed by the movement of such animals; or 
(b)  a listed disease as refer red to in point (d) of Article 9(1) appears to be spreading despite the movement requirements 
laid down in accordance with Sections 1 to 6 (Articles 124 to 142). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
2. On duly justif ied imperative grounds of urgency relating to diseases representing a risk of a highly significant 
impact and taking into account the matt ers refer red to in Article 142, the Commission shall adopt immediat ely 
applicable implementing acts in accordance with the procedure provided for in Article 266(3). 
Article 142 
Matters to be taken into account in the adoption of delegated and implementing acts as provided 
for in this Section 
When establishing the rules to be laid down in the deleg ated and imple menting acts provided for in Articles 137(2), 
138(3) and 139(4) and Articles 140 and 141, the Commission shall base those rules on the following matters: 
(a)  the risks involved with the movements refer red to in those provisions; 
(b)  the health status as regards the listed diseases refer red to in point (d) of Article 9(1) at the places of origin, passage 
and destination; 
(c)  liste d animal species for the listed diseases referred to in point (d) of Article 9(1); 
(d)  biosecur ity measures in place at the places of origin, passage and destination 
(e)  any specific conditions in establishments under which the kept terrestrial animals are kept; 
(f)  specifi c movement patter ns of the type of establishment and the species and cate gory of kept terrestrial animals 
concer ned; 
(g)  other epidemiological factors. 
Section 7 
Animal health cer tification 
Article 143 
Obligation of operat ors to ensure that animals are accompanied by an animal health certificate 
1. Operato rs shall only move the following species and catego ries of kept terrestr ial animals to another Member State 
if the animals in question are accompan ied by an animal health certificate issued by the compet ent author ity of the 
Member State of origin in accordance with Article 149(1): 
(a)  ungulates; 31.3.2016 L 84/99 Official Jour nal of the European Union EN     (b)  poultr y; 
(c)  kept terrestr ial animals other than ungulates and poultr y, intended for a conf ined establishment ; 
(d)  kept terrestr ial animals other than those refer red to in points (a), (b) and (c) of this paragraph, when required in 
accordance with delegat ed acts adopt ed pursuant to point (c) of Article 144(1). 
2. In cases where kept terrestrial animals are allowed to leave a restr icted zone as provided for in point (f)(ii) of 
Article 55(1), Article 56 and Article 64(1) and are subject to disease control measures as provided for in Articles 55(1), 
65(1), 74(1), Article 79 or Article 80 or rules adopt ed pursuant to Article 55(2), Article 67, Articles 71(3) and 74(4), 
Article 83(3) or Article 259, and the animals in question are of species subject to those disease control measures, 
operat ors shall only move such kept terrestr ial animals within a Member State or from one Member State to another 
Member State when the animals to be moved are accompan ied by an animal health certificate issued by the compet ent 
author ity of the Member State of origin in accordance with Article 149(1). 
The compet ent author ity may decide that such a certificate does not have to be issued for movements of kept terrestrial 
animals within the Member State in question when that author ity considers that an altern ative system is in place 
ensur ing that the consignment of such animals is traceable and that those animals fulfil the animal health requirements 
for such movement. 
3. Operato rs shall take all necessar y measures to ensure that the animal health certificate refer red to in paragraph 1 
of this Article accompan ies the kept terrestrial animals from their place of origin to their final place of destination, 
unless specific measures are provided for in rules adopt ed pursuant to Article 147. 
Article 144 
Delegation of powers concer ning the obligation of operat ors to ensure that animals are 
accompanied by an animal health certificate 
1. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  derogations from the animal health certification requirements provided for in Article 143(1), for movements of kept 
terrestrial animals whic h do not pose a significant risk for the spread of a disease on account of: 
(i)  the species or cate gories of the kept terrestrial animals that are being moved and the listed diseases referred to 
in point (d) of Article 9(1) for whic h they are listed species; 
(ii)  the methods of keeping and the type of production of those species and catego ries of kept terrestrial animals; 
(iii)  the intende d use of the kept terrestr ial animals; or 
(iv)  the place of destination of the kept terrestr ial animals; including those cases where their place of destination is 
in the same Member State as their place of origin but they pass through another Member State in order to reach 
their place of destination; 
(b)  special rules for animal health certification as provided for in Article 143(1) where specific risk-mitig ation measures 
concer ning surveillance or biosecur ity are take n, taking into account the matte rs provided for in paragraph 2 of this 
Article, which ensure: 
(i)  the traceability of the kept terrestrial animals being moved; 
(ii)  that the kept terrestr ial animals being moved fulfil the animal health requirements for movements provided for 
in Sections 1 to 6 (Articles 124 to 142); 
(c)  the requirement for animal health certification for movements of species and catego ries of kept terrestrial animals 
other than those referred to in points (a), (b) and (c) of Article 143(1) in cases where animal health certification is 
imp erative in order to ensure that the movement in question compl ies with the animal health requirements for 
movements provided for in Sections 1 to 6 (Articles 124 to 142). 31.3.2016 L 84/100 Official Jour nal of the European Union EN     2. When establishing the special rules provided for in point (b) of paragraph 1, the Commission shall take the 
following matt ers into account: 
(a)  the assessment by the compet ent author ity of the biosecur ity put in place by operat ors as provided for in point (b) 
of Article 10(1) and any rules adop ted pursuant Article 10(6); 
(b)  the ability of the compet ent author ity, in so far as may be necessar y and appropr iate, to take measures and to 
engag e in activities required by this Regulation as provided for in Article 13(1); 
(c)  the level of kno wledge of animal health as provided for in Article 11 and the encouragement thereof provided for in 
Article 13(2); 
(d)  the carrying-out of the animal health visits provided for in Article 25 or other relevant surveillance or official 
controls in place; 
(e)  the performa nce by the compet ent author ity of its oblig ations under the Union notifi cation and repor ting system 
provided for in Articles 19 to 22 and in the rules adopt ed pursuant to Article 20(3) and Article 23; 
(f)  the application of surveillance as provided for in Article 26 and surveillance programmes as provided for in 
Article 28 and in any rules adopt ed pursuant to Articles 29 and 30. 
3. The Commission shall take the matters refer red to in point (a)(i) to (iv) of paragraph 1 into account when 
establishing the requirements for animal health certificat ion provided for in point (c) of paragraph (1). 
Article 145 
Contents of animal health certificates 
1. The animal health certificate referred to in Article 143 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 concer ned; 
(b)  the means of transpor t and the transpor ter; 
(c)  a descr iption of the kept terrestr ial animals; 
(d)  the number of kept terrestrial animals; 
(e)  the identification and registration of kept terrestr ial animals, where required by Articles 112, 113, 114, 115 
and 117 and by any rules adop ted pursuant to Articles 118 and 120, unless derogations are provided for in 
accordance with Article 119; and 
(f)  the information needed to demonstrate that the kept terrestr ial animals fulfil the relevant animal health requirements 
in respect of movements provided for in Sections 1 to 6 (Articles 124 to 142). 
2. The animal health certificate may include other information required under other Union legislation. 
Article 146 
Delegation of powers and implementing acts concer ning the content of animal health certificates 
1. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  detailed rules on the conte nt of animal health certificates as provided for in Article 145(1) for different species and 
catego ries of kept terrestrial animals and for specific types of movements as provided for in the rules adop ted 
pursuant to Article 147; 
(b)  additional information to be contained in the animal health certificate provided for in Article 145(1). 31.3.2016 L 84/101 Official Jour nal of the European Union EN     2. The Commission may, by means of implementing acts, lay down rules for model forms of animal health 
certificates. Those implementing acts shall be adopt ed in accordance with the examination procedure refer red to in 
Article 266(2). 
Article 147 
Delegation of powers concer ning specif ic types of movements of kept terrestrial animals 
The Commission shall be emp owered to adopt delegat ed acts in accordance with Article 264 concer ning specifi c 
measures derogatin g from, or supplementing, the obligation of operat ors to ensure that animals are accompanied by an 
animal health certificate as provided for in Article 143 and in the rules adopt ed pursuant to Article 144, for the 
following types of movements of kept terrestrial animals: 
(a)  movements of kept ungulates and poultr y passing through the assembly operations provided for in Article 133 prior 
to reach ing their final place of destination; 
(b)  movements of kept terrestrial animals which are required to retur n to their place of origin or to be moved to a 
differ ent destination, for one or more of the following reasons: 
(i)  their intended jour ney was unexpectedly interr upted for animal welf are reasons; 
(ii)  unforeseen accidents or events during the jour ney; 
(iii)  they were rejected at the place of destination in a Member State or at the external border of the Union; 
(iv)  they were rejected at a place of assembly or resting; 
(v)  they were rejected in a third countr y or territory; 
(c)  movements of kept terrestr ial animals intende d for exhibitions, and spor ting, cultural and similar events, and their 
subsequent retur n to their place of origin. 
Article 148 
Operato rs' obligations to cooperate with the competent author ity for the pur poses of animal 
health certification 
Operato rs shall: 
(a)  provide the compe tent author ity with all the information necessar y to compl ete the animal health certificate 
provided for in Article 143(1) and (2) and in any rules adopt ed pursuant to Article 146(1) or Article 147, in 
advance of the intended movement ; 
(b)  where necessar y, ensure that the kept terrestr ial animals in question are subjecte d to documentar y, identity and 
physical checks as provided for in Article 149(3). 
Article 149 
Responsibility of the competent author ity for animal health certification 
1. The compet ent author ity shall, upon request by an operat or, issue an animal health certificate for the movement of 
kept terrestr ial animals, where required by Article 143 or by delegat ed acts adopt ed pursuant to Article 144(1), provided 
that the following movement requirements have been compl ied with: 
(a)  those provided for in Article 124, Article 125(1), Articles 126, 128, 129, 130, 133 and 134, Articles 136(1) 
and 137(1), Article 138 and Article 139; 31.3.2016 L 84/102 Official Jour nal of the European Union EN     (b)  those provided for in delegat ed acts adopt ed pursuant to Articles 125(2) and 131(1), Article 135, Articles 136(2), 
137(2), 138(4) and 139(4) and Article 140; 
(c)  those provided for in implementing acts adopt ed pursuant to Article 141. 
2. Animal health certificates shall: 
(a)  be verified, stam ped and signed by an official veterinar ian; 
(b)  remain valid for the period of time provided for in the rules adopt ed pursuant to point (c) of paragraph 4, during 
which the kept terrestr ial animals covered by it continue to fulfil the animal health guarant ees contained in it. 
3. Before signing an animal health certificate, the official veteri narian concer ned shall verify, by means of 
documentar y, identity and physical checks as provided for by delegat ed acts adopt ed pursuant to paragraph 4, that the 
kept terrestrial animals covered by it fulfil the requirements of this Chapt er. 
4. The Commission shall adopt delegat ed acts in accordance with Article 264 laying down rules concer ning: 
(a)  the types of documentar y, identity and physical chec ks and examinations in relation to different species and 
catego ries of kept terrestr ial animals that must be carried out by the official veteri narian in accordance with 
paragraph 3 in order to verify compliance with the requirements of this Chapt er; 
(b)  the timeframes for the carrying-out of such documentar y, identity and physical chec ks and examinations and the 
issuing of animal health certificates by the official veteri narian prior to the movement of consignments of kept 
terrestrial animals; 
(c)  the duration of the validity of animal health certificates. 
Article 150 
Electronic animal health certificates 
Electronic animal health certificates, produced, handled and transmitted by means of Traces, may replace accompan ying 
animal health certificates as provided for in Article 149(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 145 and any rules adopt ed pursuant to Article 146; 
(b)  the traceability of the kept terrestrial animals in question and the link between those animals and the electronic 
animal health certificate is ensured; 
(c)  the compet ent author ities of the Member States of origin, passage and destination are able to have access to the 
electronic documents at all times during the transpor t. 
Article 151 
Self–declaration by operators for movements to other Member States 
1. Operato rs 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 shall ensure 
that it accompan ies such animals, where they are not required to be accompan ied by an animal health certificate as 
provided for in Article 143(1) and (2). 
2. The self–declaration document provided for in paragraph 1 shall contain the following information concer ning the 
kept terrestrial animals in question: 
(a)  their place of origin, their place of destination and, when relevant, any places of assembly or rest; 
(b)  the means of transpor t and the transpor ter; 31.3.2016 L 84/103 Official Jour nal of the European Union EN     (c)  a descr iption of the kept terrestr ial animals, their species, cate gory and quantity ; 
(d)  identif ication and registration where required in accordance with Articles 112, 113, 114 and 115, point (a) of 
Article 117 and any rules adopt ed pursuant to Articles 118 and 120; 
(e)  the information needed to demonstrate that the kept terrestrial animals fulfil the animal health requirements for 
movements provided for in Sections 1 to 6 (Articles 124 to 142). 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  detailed rules on the content of the self–declaration document provided for in paragraph 2 of this Article for 
differ ent species and categor ies 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 imple menting acts, lay down rules for the model forms of the self–declaration 
document provided for in paragraph 2 of this Article. Those imple menting acts shall be adopt ed in accordance with the 
examination procedure refer red to in Article 266(2). 
Section 8 
Notif ication of mo vements of kept ter rest rial animals to other Member States 
Article 152 
Obligation of operat ors concer ning the notif ication of movements of kept terrest rial animals to 
other Member States 
Operato rs other than transpor ters shall notify the compet ent author ity in their Member State of origin in advance of 
intende d 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 compet ent author ity of the Member 
State of origin in accordance with Articles 149 and 150 and any rules adop ted pursuant to Article 149(4); 
(b)  the animals must be accompanied by an animal health certificate for kept terrestr ial animals where they are being 
moved from a restr icted zone and are subject to disease control measures as refer red to in Article 143(2); 
(c)  the animals are granted a deroga tion from the animal health certificat ion requirement provided for in point (a) of 
Article 144(1) or are subject to special rules as provided for in point (b) of Article 144(1); 
(d)  notificati on is required in accordance with delegat ed acts adop ted pursuant to Article 154(1). 
For the purposes of the first paragraph of this Article, operat ors shall provide the compet ent author ity of their Member 
State of origin with all the necessar y information to enable it to notify the movements of the kept terrestrial animals to 
the compet ent author ity of the Member State of destination in accordance with Article 153(1). 
Article 153 
Responsibility of the competent author ity to notify movements to other Member States 
1. The compet ent author ity of the Member State of origin shall notify the compet ent author ity of the Member State 
of destination of movements of kept terrestrial animals as refer red to in Article 152. 
2. The notifi cation refer red to in paragraph 1 shall be carried out prior to the movement in question and, whenever 
possible, through Traces. 31.3.2016 L 84/104 Official Jour nal of the European Union EN     3. Member States shall designat e regions for the managemen t of notifications of movements as provided for in 
paragraph 1. 
4. By way of derogation from paragraph 1, the compet ent author ity of the Member State of origin may author ise the 
operat or concer ned to notify , partially or compl etely , movements of kept terrestrial animals through Traces to the 
compet ent author ity of the Member State of destination. 
Article 154 
Delegation of power and implementing acts for the notif ication of movements by operat ors and 
by the competent author ity 
1. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the requirement for advance notificati on by operat ors, in accordance with Article 152, of movements between 
Member States of kept terrestr ial animals of species or catego ries other than those refer red to in points (a) and (b) of 
that Article, where traceability of such movements of those species or catego ries is necessar y in order to ensure 
compl iance with the animal health requirements for movements laid down in Sections 1 to 6 (Articles 124 to 142); 
(b)  the information needed in order to notify movements of kept terrestrial animals as provided for in Articles 152 
and 153; 
(c)  the emerge ncy procedures for the notificati on of movements of kept terrestr ial animals in the event of power cuts 
and other disturbances of Traces; 
(d)  the requirements for the designation of regions by Member State s for the manag ement of notifications of 
movements, as provided for in Article 153(3). 
2. The Commission may, by means of imp lementing acts, lay down rules concer ning: 
(a)  the details concer ning notifications of movements of kept terrestrial animals by: 
(i)  operators to the compet ent author ity of their Member State of origin in accordance with Article 152; 
(ii)  the compet ent author ity of the Member State of origin to the Member State of destination in accordance with 
Article 153; 
(b)  the deadlines for: 
(i)  the provision by the operat or of the necessar y information refer red to in Article 152 to the compet ent author ity 
of the Member State of origin; 
(ii)  the notifi cation of movements of kept terrestrial animals by the compet ent author ity of the Member State of 
origin as referred to in Article 153(1). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 4 
Movements of wild terrestr ial animals 
Article 155 
Wild terrestrial animals 
1. Operato rs shall only move wild animals from a habitat in one Member State to a habitat or an establishment in 
another Member State where: 
(a)  the movements of the wild animals in question from their habitat are carried out in such a way that they do not 
pose a signif icant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) or emerging diseases 
en route or at the place of destination; 31.3.2016 L 84/105 Official Jour nal of the European Union EN     (b)  the wild animals do not come from a habitat in a restr icted zone whic h is subject to movement restr ictions 
concer ning the animal species to whic h they belong due to the occur rence of a listed disease as refer red to in 
point (d) of Article 9(1) or of an emerging disease, as provided for in Article 70(2) and in any rules adopt ed 
pursuant to point (b) of Article 70(3), Article 71(3) and Article 83(3) or the emergency measures provided for in 
Articles 257 and 258 and any rules adop ted pursuant to Article 259, unless derogat ions have been grant ed in 
accordance with those rules; 
(c) the wild animals are accompan ied by an animal health certificate or other documents where animal health certifi­
cation is necessar y in order to ensure compliance with the animal health requirements for movements provided for 
in points (a) and (b) of this paragraph and the rules adopt ed pursuant to points (c) and (d) of Article 156(1); 
(d)  the movements are notified by the compet ent author ity of the Member State of origin to the compet ent author ity of 
the Member State of destination, where animal health certification is required by the rules adopt ed pursuant to 
point (c) of Article 156(1); and 
(e)  the compet ent author ity of the Member State of origin and the compet ent author ity of the Member State of 
destination have agreed to such movement. 
2. When animal health certification is required by the rules adopt ed pursuant to point (c) of Article 156(1), the 
requirements provided for in Articles 145 and 148, Article 149(1), (2) and (3) and Article 150, and in the rules adop ted 
pursuant to Articles 146 and 147 and Article 149(4) shall apply to movements of wild terrestrial animals. 
3. When notification of movements is required in accordance with point (d) of paragraph 1 of this Article, the 
requirements provided for in Articles 152 and 153 and in the delegat ed acts adopt ed pursuant to Article 154(1) shall 
apply to movements of wild terrestrial animals. 
Article 156 
Empo werments concer ning the movement of wild terrest rial animals 
1. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the animal health requirements for movements of wild terrestrial animals provided for in points (a) and (b) of 
Article 155(1); 
(b)  the animal health requirements for the introduction of wild terrestrial animals when they are moved from the wild 
into establishments; 
(c)  the types of movements of wild terrestr ial animals for which , or the situations in which , an animal health certificate 
or other document is required to accompan y such movements, and the requirements concer ning the contents of 
such certificates or other documents; 
(d)  the notifi cation by the compe tent author ity of the Member State of origin to the compet ent author ity of the Member 
State of destination in the case of movements of wild terrestr ial animals between Member States, and the 
information to be included in such notificati on. 
2. The Commission may, by means of imple menting acts, lay down rules specifying the requirements provided for in 
Article 155 and in the delegat ed acts adopt ed pursuant to paragraph 1 of this Article, concer ning: 
(a)  model forms of animal health certificates and other documents which are required to accompan y movements of 
wild terrestrial animals, when provided for in delegat ed acts adopt ed pursuant to point (c) of paragraph 1 of this 
Article; 
(b)  the details of the notification to be given by the compet ent author ity of the Member State of origin and the 
deadlines for such notific ations, when provided for in rules adopt ed pursuant to point (d) of paragraph 1 of this 
Article. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 31.3.2016 L 84/106 Official Jour nal of the European Union EN     CHAPTER 5 
Movements within the Union of germinal produ cts 
Section 1 
General requirements 
Article 157 
General requirements for movements of germinal products 
1. Operato rs shall take appropr iate preventive measures to ensure that movements of germinal products do not 
jeopardise the health status of kept terrestr ial animals at the place of destination with regard to: 
(a)  the liste d diseases referred to in point (d) of Article 9(1); 
(b)  emerging diseases. 
2. Operato rs shall only move germinal products from their establishments, and receive such germinal products, if the 
products in question fulfil the following conditions: 
(a)  they come from establishments that have been: 
(i)  entered in the register of establishments by the compet ent author ity in accordance with point (a) of the first 
paragraph of Article 93 and no derogation has been grant ed by the Member State of origin in accordance with 
Article 85; 
(ii)  appro ved by the compe tent author ity in accordance with Article 97(1), when such appro val is required by 
Article 94(1) or Article 95; 
(b)  they fulfil the traceability requirements of Article 121(1) and any rules adopt ed pursuant to Article 122(1). 
3. Operato rs shall comply with the requirements of Article 125 for the transpor t of germinal products of kept 
terrestr ial animals. 
4. Operato rs shall not move germinal products from an establishment in one Member State to an establishment in 
another Member State unless the compet ent author ity of the Member State of destination gives its express author isation 
for such movement, where those germinal products are required to be destro yed for disease eradication purposes as part 
of an eradication programme as provided for in Article 31(1) or (2). 
Article 158 
Obligations for operat ors at the place of destination 
1. Operato rs 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)  marks in accordance with Article 121 and with rules adopt ed pursuant to Article 122; 
(ii)  animal health certificates as provided for in Article 161; 
(b)  after checkin g the germinal products received, inform the compet ent author ity of the place of destination of any 
irregular ity with regard to; 
(i)  the germinal products received; 
(ii)  the marks refer red to in point (a)(i); 
(iii)  the animal health certificates refer red to in point (a)(ii). 
2. In the event of an irregular ity as refer red to in point (b) of paragraph 1, the operat or concer ned shall keep the 
germinal products stored separate ly until the compet ent author ity has taken a decision regar ding them. 31.3.2016 L 84/107 Official Jour nal of the European Union EN     Section 2 
Mo vements to other Member States of ger minal products of kept animals of the 
bovine, ovine, capr ine, porcine and equine species and ger minal products of 
poultr y 
Article 159 
Operato rs' obligations in respect of movements to other Member States of germinal products of 
kept animals of the bovine, ovine, capr ine, porcine and equine species and germinal products of 
poultr y 
1. Operato rs shall only move germinal products of kept animals of the bovine, ovine, capr ine, porcine and equine 
species and germinal products of poultr y to another Member State if those germinal products fulfil the following 
conditions: 
(a)  they are collect ed, produced, processed and store d in germinal product establishments appro ved for that purpose in 
accordance with Article 97(1) and Article 99; 
(b)  they have been collected from donor animals whic h fulfil the necessar y animal health requirements, in order to 
ensure that the germinal products do not spread listed diseases; 
(c)  they have been collected, produced, processed, store d and transpor ted in such a way as to ensure that they do not 
spread listed diseases as refer red to in point (d) of Article 9(1). 
2. Operato rs shall not move germinal products of kept animals of the bovine, ovine, capr ine, porcine and equine 
species and germinal products of poultr y from a germinal product establishment which is subject to movement 
restr ictions affecting the listed species in question in accordance with: 
(a)  points (a), (c) and (e) of Article 55(1), point (f)(ii) of Article 55(1), Article 56, point (a) of Article 61(1), Article 62(1), 
point (c) of Article 65(1), Article 74(1), and Articles 79 and 80; 
(b)  rules adopt ed pursuant to Article 55(2), Articles 63 and 67, and Articles 71(3), 74(4) and 83(2); and 
(c)  emerge ncy measures as provided for in Articles 257 and 258 and rules adop ted pursuant to Article 259, unless 
derogations have been provided for in rules adop ted pursuant to Article 258. 
The restr ictions provided for in this paragraph shall not apply to cases where the germinal products were collected 
before the outbreak in question occur red and those products have been stored separate ly from other germinal products. 
Article 160 
Delegation of power in respect of movements to other Member States of germinal products of 
kept animals of the bovine, porcine, ovine, capr ine and equine species and germinal products of 
poultr y 
1. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning the animal health 
requirements for movements of germinal products of kept animals of the bovine, ovine, capr ine, porcine and equine 
species and germinal products of poultr y to other Member States as provided for in Article 159, specifying: 
(a)  rules for the collection, production, processing and storage of germinal products of those kept animals in appro ved 
establishments as refer red to in point (a) of Article 159(1); 
(b)  animal health requirements as provided for in point (b) of Article 159(1) for kept donor animals from which 
germinal products were collect ed, and concer ning isolation or quarantine for those animals; 
(c)  laboratory and other tests to be carried out on kept donor animals and germinal products; 31.3.2016 L 84/108 Official Jour nal of the European Union EN     (d)  animal health requirements for the collection, production, processing, storag e or other procedures and transpor t 
provided for in point (c) of Article 159(1). 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
animal health requirements for movements of germinal products of kept animals of the bovine, ovine, capr ine, porcine 
and equine species and germinal products of poultr y to other Member State s as provided for in Article 159, specifying 
derogat ions for operat ors from the rules provided for in Article 159, taking into account the risks attache d to such 
germinal products and any risk-mitigation measures in place. 
Section 3 
Animal health cer tification and notif ication of mo vements 
Article 161 
Operato rs' obligations concer ning animal health certification for movements of germinal products 
of kept animals of the bovine, ovine, capr ine, porcine and equine species and germinal products of 
poultr y and delegated acts 
1. Operato rs shall only move germinal products of kept animals of the bovine, ovine, capr ine, porcine and equine 
species and germinal products of poultr y to another Member State where such products are accompanied by an animal 
health certificate issued by the compet ent author ity of the Member State of origin in accordance with paragraph 3; 
2. In cases where germinal products of kept animals are allowed to leav e a restr icted zone subject to: 
(a)  disease control measures as provided for in point (f)(ii) of Article 55(1), Articles 56, 64 and 65, Article 74(1) and 
Article 79, and the rules adopt ed pursuant to Article 55(2), Article 67, Articles 71(3) and 74(4), Article 83(2), or 
(b)  emerge ncy measures as provided for in Articles 257 and 258 and the rules adopt ed pursuant to Article 259, 
and those germinal products are of species subject to those disease control or emerge ncy measures, operat ors shall only 
move such germinal products within a Member State or from one Member State to another Member State when they are 
accompan ied by an animal health certificate issued by the compet ent author ity of the Member State of origin in 
accordance with Article 149(1), unless derog ations have been granted from the animal health certificat ion requirement 
in accordance with the rules referred in this subparagraph. 
The compet ent author ity may decide that such a certificate does not have to be issued for movements of germinal 
products within the Member State concer ned when that author ity considers that an alternative system is in place 
ensur ing that the consignment of such germinal products is traceable and that those germinal products compl y with the 
animal health requirements for such movement. 
3. Operato rs shall take all necessar y measures to ensure that the animal health certificate refer red to in paragraph 1 
accompan ies the germinal products from their place of origin to their place of destination. 
4. The compet ent author ity shall, upon request by an operat or, issue an animal health certificate for the movements 
of germinal products refer red to in paragraph 1, provided that the relevant requirements referred to in Chapt er 5 of 
Title I of Part IV have been compl ied with. 
5. Articles 148, 149 and 150, and the rules adop ted pursuant to Articles 146 and 147 and Article 149(4), shall 
apply to the animal health certification of the germinal products refer red to in paragraph 1 of this Article. 
Article 151(1) and the rules adopt ed pursuant to Article 151(3) shall apply to the self–declaration of movements of 
germinal products. 
6. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
derogat ions from the animal health certificate requirements provided for in paragraph 1 of this Article as regards 
movements of germinal products of kept animals of the bovine, ovine, capr ine, porcine and equine species and germinal 
products of poultr y which do not pose a signif icant risk for the spread of liste d diseases due to: 
(a)  the nature of the germinal products concer ned or the species of animal that those products come from; 31.3.2016 L 84/109 Official Jour nal of the European Union EN     (b)  the methods of production and processing at the germinal product establishment ; 
(c)  the intended use of the germinal products; 
(d)  alternati ve risk-mitig ation measures in place for the type and catego ry of germinal products and the germinal 
product establishment ; 
(e)  the place of destination of the germinal products, when the place of destination is in the same Member State as the 
place of origin but the germinal products pass through another Member State in order to reac h the place of 
destination. 
Article 162 
Content of animal health certificates 
1. The animal health certificate for the germinal products provided for in Article 161 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 or number of the germinal products; 
(d)  the marking of the germinal products, when required by Articles 121(1) and by any rules adopt ed pursuant to 
Article 122(1); 
(e)  the information needed to demonstrate that the germinal products of the consignment fulfil the movement 
requirements for the relevant species as provided for in Articles 157 and 159 and in any rules adopt ed pursuant to 
Article 160. 
2. The animal health certificate for germinal products as provided for in Article 161 may include other information 
required under other Union legislation. 
3. The Commission shall adopt delega ted acts in accordance with Article 264 concer ning the information to be 
contained in the animal health certificate pursuant to paragraph 1 of this Article; 
4. The Commission shall be empowered to adopt deleg ated acts in accordance with Article 264 concer ning animal 
health certification for differ ent types of germinal products and of diffe rent animal species. 
5. The Commission may, by means of implementing acts, lay down rules concer ning model forms of animal health 
certificates for germinal products. Those implementing acts shall be adopt ed in accordance with the examination 
procedure refer red to in Article 266(2). 
Article 163 
Notif ication of movements of germinal products of kept animals of the bovine, ovine, capr ine, 
porcine and equine species and germinal products of poultr y to other Member States 
1. Operato rs shall: 
(a)  inform the compet ent author ity in their Member State of origin in advance of the intended movement of germinal 
products of kept animals of the bovine, ovine, capr ine, porcine and equine species and germinal products of poultr y 
to another Member State when: 
(i)  the germinal products in question are required to be accompan ied by an animal health certificate in accordance 
with Article 161(1) or (2); 
(ii)  notifi cation of movement is required in accordance with delegat ed acts adopt ed pursuant to point (a) of 
paragraph 5 of this Article for germinal products, taking into account paragraph 3 of this Article; 31.3.2016 L 84/110 Official Jour nal of the European Union EN     (b)  provide all the necessar y information to enable the compet ent author ity of the Member State of origin to notify the 
movement of the germinal products to the compet ent author ity of the Member State of destination in accordance 
with paragraph 2. 
2. The compet ent author ity of the Member State of origin shall notify , prior to the movement in question and 
whenever possible through Traces, the compet ent author ity of the Member State of destination of any movement of 
germinal products of kept animals of the bovine, ovine, capr ine, porcine and equine species and germinal products of 
poultr y in accordance with the rules adopt ed pursuant to paragraphs 5 and 6. 
3. Member States shall use, for the management of notifications, regions designat ed in accordance with 
Article 153(3). 
4. Article 153(4) shall apply to the notificati on of germinal products by operat ors. 
5. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the requirement for advance notification by operat ors of movements of germinal products between Member States 
in accordance with point (a)(ii) of paragraph 1 of this Article, where traceability of such movements is necessar y in 
order to ensure compliance with the animal health requirements for movements laid down in Sections 1 and 2 
(Articles 157 to 160); 
(b)  information necessar y to notify movements of germinal products as provided for in paragraph 1 of this Article; 
(c)  the emerge ncy procedures for the notification of movements of germinal products in the event of power cuts and 
other disturbances of Traces. 
6. The Commission may, by means of imp lementing acts, lay down rules concer ning: 
(a)  the provision of information on movements of germinal products by operat ors to the compet ent author ity of their 
Member State of origin in accordance with paragraph 1; 
(b)  notificati on by the compet ent author ity of the Member State of origin to the Member State of destination of 
movements of germinal products in accordance with paragraph 2; 
(c)  the deadlines for: 
(i)  the provision of the information refer red to in paragraph 1 by the operat or to the compet ent author ity of the 
Member State of origin; 
(ii)  notifi cation by the compet ent author ity of the Member State of origin of movements of germinal products as 
refer red to in paragraph 2. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Section 4 
Mo vements to other Member State s of ger minal products of kept ter rest rial 
animals of species other than bovine, ovine, capr ine, porcine and equine species 
and ger minal products of poultr y 
Article 164 
Ger minal products of kept terrest rial animals other than those of the bovine, ovine, capr ine, 
porcine and equine species and germinal products of poultr y 
1. Operato rs shall only move germinal products of kept terrestrial animals of species other than those of the bovine, 
ovine, capr ine, porcine and equine species and germinal products of poultr y to another Member State if those products 
do not pose a signif icant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to listed species at 
the place of destination, taking into account the health status at the place of destination. 31.3.2016 L 84/111 Official Jour nal of the European Union EN     2. The Commission shall be empowered to adopt deleg ated acts in accordance with Article 264 concer ning animal 
health requirements, animal health certification and notifi cation requirements for movements of germinal products of 
kept terrestr ial animals of species other than those of the bovine, ovine, capr ine, porcine and equine species and 
germinal products of poultr y, taking into account the following matt ers: 
(a)  liste d diseases as refer red to in point (d) of Article 9(1) for the listed species concer ned; 
(b)  the species of animals from which the germinal products have been collect ed and the 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 notification of movements of germinal products are required in accordance 
with paragraph 2: 
(a)  the rules provided for in Articles 161(1) to (5), 162 (1) and (2) and the rules adopt ed pursuant to Articles 161(6) 
and 162(3) to (5) shall apply for such certification; 
(b)  the rules provided for in Article 163(1), (2) and (4) and the rules adopt ed pursuant to Article 163(5) shall apply for 
notificati on of movements. 
Section 5 
Derogations 
Article 165 
Ger minal products intended for scientif ic pur poses and delegated acts 
1. The compet ent author ity of the place of destination may, subject to the agreement of the compet ent author ity of 
the place of origin, author ise movements of germinal products into the territory of the Member State of destination, for 
scientific purposes, where those movements do not fulfil the requirements of Articles 159 to 164. 
2. The compet ent author ity shall only grant derog ations provided for in paragraph 1 under the following conditions: 
(a)  the compet ent author ities of the places of destination and origin: 
(i)  have agreed on the conditions for the movements proposed; 
(ii)  ensure that necessar y risk-mitig ation measures are in place so that those movements do not jeopardise the 
health status en route and in the place of destination with regar d to the listed diseases refer red to in point (d) of 
Article 9(1); 
(iii)  have notified , where relevant, the compet ent author ities of Member States of passage of the derogation grant ed 
and of the conditions under which it is granted; 
(b)  those movements take place under the super vision of the compet ent author ities of the places of origin and 
destination, and where relevant, of the compet ent author ities of any Member State s of passage. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the rules 
for the granting of derog ations by compet ent author ities, supplementing those provided for in paragraphs 1 and 2 of 
this Article. 31.3.2016 L 84/112 Official Jour nal of the European Union EN     CHAPTER 6 
Production, processing and distr ibution within the Union of products of animal origin 
Article 166 
General animal health obligations for operators and delegated acts 
1. Operato rs shall take appropr iate preventive measures to ensure that, during all stages of the production, processing 
and distr ibution of products of animal origin in the Union, such products do not cause the spread of: 
(a)  liste d diseases as refer red to in point (d) of Article 9(1), taking into account the health status of the place of 
production, processing or destination; 
(b)  emerging diseases. 
2. Operato rs shall ensure that products of animal origin do not come from establishments or food businesses, or are 
not obtained from animals whic h come from establishments, that are subject to: 
(a)  emerge ncy measures as provided for in Articles 257 and 258 or any rules adop ted pursuant to Article 259, unless 
derogations from the requirement provided for in paragraph 1 of this Article are provided for in rules adop ted 
pursuant to Article 259; 
(b)  movement restr ictions applicable to kept terrestr ial animals and products of animal origin, as provided for in 
point (c) of Article 32(1), point (e) of Article 55(1), Article 56, point (a) of Article 61(1), Article 62(1), point (c) of 
Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1), point (b) of Article 76(2), Article 76(3), 
Article 79, Article 81 and Article 82(2) and (3) and in the rules adopt ed pursuant to Article 55(2), Articles 63 
and 67, Article 70(3), Article 71(3), Article 74(4), Article 76(5) and Article 83(2), unless derogations from those 
movement restr ictions have been provided for in those rules. 
3. The Commission shall adop t delegat ed acts in accordance with Article 264 concer ning detailed requirements 
supplementing those refer red to: 
(a)  in paragraph 1 of this Article on preventive measures, including risk-mitiga tion measures, and 
(b)  in paragraph 2 of this Article in relation to restr ictions on movements of products of animal origin. 
4. When adopt ing the delegat ed acts refer red to in paragraph 3, the Commission shall base those acts on: 
(a)  the liste d disease in question, as refer red to in point (d) of Article 9(1), and species concer ned by it and 
(b)  the risks involved. 
Article 167 
Operato rs' obligations with regard to animal health certificates and delegated acts 
1. Operato rs shall only move the following products of animal origin within a Member State or to another Member 
State where the products in question are accompanied by an animal health certificate issued by the compet ent author ity 
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 restr icted zone subject to emergency measures as provided for in rules adopt ed 
pursuant to Article 259; 
(ii)  originat e from animals of species subject to those emerg ency measures; 31.3.2016 L 84/113 Official Jour nal of the European Union EN     (b)  products of animal origin that: 
(i)  are allowed to be moved from a restr icted zone subject to disease control measures in accordance with 
Article 32(1), point (f)(ii) of Article 55(1), Article 56, point (a) of Article 61(1), Article 62(1), Article 64, 
point (c) of Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1) and Articles 79 and 80 and any 
rules adopt ed pursuant to Article 55(2), Articles 63 and 67 and Articles 71(3), 74(4) and 83(2), 
(ii)  originat e from animals of species subject to those disease control measures. 
The compet ent author ity may decide that such a certificate does not have to be issued for movements of products of 
animal origin within the Member State concer ned when that author ity considers that an alternative system is in place 
ensur ing that consignments of such products are traceable and that those products fulfil the animal health requirements 
for such movements. 
2. Operato rs shall take all necessar y measures to ensure that the animal health certificate refer red to in paragraph 1 
accompan ies the products of animal origin from their place of origin to their place of destination. 
3. The compet ent author ity shall, upon request by the operat or concer ned, issue an animal health certificate for 
movements of products of animal origin as referred to in paragraph 1, provided that the relevant requirements refer red 
to in this Article have been compl ied with. 
4. Articles 148, 149 and 150 and the rules adopt ed pursuant to Articles 146 and 147 and Article 149(4) shall apply 
to the animal health certification of movements of products of animal origin as refer red to in paragraph 1 of this 
Article. 
5. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
derogat ions from the animal health certificate requirements provided for in paragraph 1 of this Article and the 
conditions for such derogations, in respect of movements of products of animal origin which do not pose a signif icant 
risk for the spread of diseases due to: 
(a)  the types of products of animal origin concer ned; 
(b)  the risk-mitig ation 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 168 
Content of animal health certificates and delegated and implementing acts 
1. The animal health certificate for products of animal origin provided for in Article 167(1) shall contain at least the 
following information: 
(a)  the establishment or place of origin and the establishment or place of destination; 
(b)  a descr iption of the products of animal origin concer ned; 
(c)  the quantity of the products of animal origin; 
(d)  the identification of the products of animal origin, when required by point (h) of Article 65(1) or by any rules 
adopt ed pursuant to point (a) of the second paragraph of Article 67; 
(e)  the information needed to demonstrate that the products of animal origin fulfil the movement restr iction 
requirements provided for in Article 166(2) and in any rules adopt ed pursuant to Article 166(3). 31.3.2016 L 84/114 Official Jour nal of the European Union EN     2. The animal health certificate referred to in paragraph 1 may include other information required under other Union 
legislation. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
information to be contained in the animal health certificate provided for in paragraph 1 of this Article. 
4. The Commission may, by means of implementing acts, lay down rules concer ning model forms of animal health 
certificates for products of animal origin referred to in paragraph 1 of this Article. Those implementing acts shall be 
adopt ed in accordance with the examination procedure refer red to in Article 266(2). 
Article 169 
Notif ication of movements of products of animal origin to other Member States 
1. Operato rs shall: 
(a)  inform the compet ent author ity in their Member State of origin in advance of intended movements of products of 
animal origin when the consignments in question are required to be accompan ied by an animal health certificate in 
accordance with Article 167(1); 
(b)  provide all necessar y information to enable the compet ent author ity of the Member State of origin to notify the 
movement in question to the compet ent author ity of the Member State of destination in accordance with 
paragraph 2. 
2. The compet ent author ity of the Member State of origin shall, prior to the movement and whenever possible 
through Traces, notify the compet ent author ity of the Member State of destination of movements of products of animal 
origin in accordance with the rules adopt ed pursuant to paragraphs 5 and 6. 
3. Member States shall use, for the management of notifications, regions designat ed in accordance with 
Article 153(3). 
4. Article 153(4) shall apply to the notificati on of movements of products of animal origin by operators. 
5. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the information needed for the notificati on of movements of products of animal origin as provided for in 
paragraph 1 of this Article; 
(b)  the emerge ncy procedures for the notificati on of movements of products of animal origin in the event of power cuts 
and other disturbances of Traces. 
6. The Commission may, by means of imp lementing acts, lay down rules concer ning: 
(a)  the information to be provided by operat ors to the compet ent author ity of their Member State of origin concer ning 
movements of products of animal origin in accordance with paragraph 1; 
(b)  notificati on of movements of products of animal origin to be given by the compet ent author ity of the Member State 
of origin to the Member State of destination in accordance with paragraph 2; 
(c)  the deadlines for: 
(i)  provision of the information refer red to in paragraph 1 by the operat or concer ned to the compet ent author ity of 
the Member State of origin; 
(ii)  notifi cation of movements of products of animal origin to be given by the compe tent author ity of the Member 
State of origin as refer red to in paragraph 2. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 31.3.2016 L 84/115 Official Jour nal of the European Union EN     CHAPTER 7 
Scope of national measur es 
Article 170 
National measures concer ning disease control and movements of animals and germinal products 
1. Member States shall remain free to take national measures to control liste d diseases as refer red to in points (d) 
and (e) of Article 9(1) with rega rd to movements of terrestrial animals and germinal products thereof within their own 
territories. 
2. Those national measures shall: 
(a)  take account of the rules on movements of animals and germinal products laid down in Chapt ers 3 (Articles 124 
to 154), 4 (Articles 155 and 156) and 5 (Articles 157 to 165), and shall not be inconsist ent with those rules; 
(b)  not hinder the movement of animals and products between Member States; 
(c)  not exceed the limits of what is appropr iate and necessar y in order to prevent the introduction and spread of the 
liste d diseases referred to in points (d) and (e) of Article 9(1). 
Article 171 
National measures designed to limit the impact of diseases other than listed diseases 
Where a disease other than a listed disease constitutes a signif icant risk for the health of kept terrestrial animals in a 
Member State , the Member State concer ned may take national measures to control that disease and may restr ict 
movements of kept terrestrial animals and germinal products, provided those measures do not: 
(a)  hinder the movement of animals and products between Member State s; 
(b)  exceed the limits of what is appropr iate and necessar y in order to control that disease. 
TITLE II 
AQUATIC ANIMALS AND PRODUCTS OF ANIMAL ORIGIN FROM AQUATIC ANIMALS 
CHAPTER 1 
Registr ation, approv al, recor d-keeping and registers 
Section 1 
Regist ration of aquaculture establishments 
Article 172 
Obligation of operat ors to regis ter aquaculture establishments 
1. Operato rs of aquaculture establishments shall, in order for their establishments to be registere d in accordance with 
Article 173, before they commence such activities: 
(a)  inform the compet ent author ity of any aquaculture establishment under their responsibility ; 
(b)  provide the compet ent author ity with the following information: 
(i)  the name and address of the operat or concer ned; 
(ii)  the location of the establishment and a descr iption of its facilities; 31.3.2016 L 84/116 Official Jour nal of the European Union EN     (iii)  the species, catego ries and quantities (numbers, volume or weight) of aquaculture animals whic h they intend to 
keep on the aquaculture establishment and the capacity of the aquaculture establishment ; 
(iv)  the type of aquaculture establishment ; and 
(v)  any other aspects of the establishment whic h are relevant for the purpose of determining the risk posed by it. 
2. Operato rs of aquaculture establishments refer red to in paragraph 1 shall inform the compet ent author ity in 
advance of: 
(a)  any significant change s in the aquaculture establishment in question concer ning the matt ers refer red to in point (b) 
of paragraph 1; 
(b)  any cessation of activity by the operat or or aquaculture establishment concer ned. 
3. Aquaculture establishments whic h are subject to appro val in accordance with Article 176(1) and Article 177 shall 
not be required to provide the information refer red to in paragraph 1 of this Article. 
4. An operat or may apply for registration as provided for in paragraph 1 to cover a group of aquaculture 
establishments, provided that they fulfil either of the following conditions: 
(a)  they are located in an epidemiologically linked area and all operat ors in that area operate under a common 
biosecur ity system ; 
(b)  they are under the responsibility of the same operator and operate under a common biosecur ity system, and the 
aquaculture animals of the establishments concer ned form part of a sing le epidemiological unit. 
Where an application for registration covers a group of establishments, the rules laid down in paragraphs 1 to 3 of this 
Article and in point (b) of the first paragraph of Article 173, and the rules adopt ed pursuant to Article 175 which are 
applicable to a sing le aquaculture establishment, shall be applicable to the group of aquaculture establishments as a 
whole. 
Article 173 
Obligations of the competent author ity concer ning the regis tration of aquaculture establishments 
A compe tent author ity shall register: 
(a)  aquaculture establishments in the register of aquaculture establishments provided for in Article 185(1), where the 
operat or concer ned has provided the information required in accordance with Article 172(1); 
(b)  groups of aquaculture establishment in that register , provided that the criteria laid down in Article 172(4) are 
compl ied with. 
The compet ent author ity shall assign each establishment or group of establishments as refer red to in this Article with a 
unique registration number . 
Article 174 
Derogations from the obligation of operat ors to register aquaculture establishments 
By way of derog ation from Article 172(1), Member States may exem pt from the registration requirement certain 
aquaculture establishments posing an insignificant risk, as provided for in an implementing act adopt ed in accordance 
with Article 175. 31.3.2016 L 84/117 Official Jour nal of the European Union EN     Article 175 
Implementing powers concer ning derogations from the obligation to register aquaculture 
establishments 
1. The Commission may, by means of implementing acts, lay down rules concer ning the information to be provided 
by operat ors for the purpose of the registration of aquaculture establishments as provided for in Article 172(1), 
including the time-limits by whic h such information is to be provided. 
2. The Commission shall, by means of implementing acts, lay down rules concer ning the types of aquaculture 
establishments that may be exem pted by Member State s from the registration requirement in accordance with 
Article 174, based on: 
(a)  the species, catego ries and quantity (number , volume or weight) of aquaculture animals on the aquaculture 
establishment in question and the capacity of that establishment ; 
(b)  the movements of aquaculture animals into and out of the aquaculture establishment. 
3. The implementing acts referred to in this Article shall be adopt ed in accordance with the examination procedure 
referred to in Article 266(2). 
Section 2 
Appro val of cer tain types of aquaculture establishments 
Article 176 
Appro val of certain aquaculture establishments and delegated acts 
1. Operato rs of the following types of aquaculture establishments shall apply to the compet ent author ity for appro val 
in accordance with Article 180(1): 
(a)  aquaculture establishments where aquaculture animals are kept with a view to their being moved therefrom, either 
alive or as products of aquaculture animal origin; 
(b)  other aquaculture establishments which pose a signif icant risk due to: 
(i)  the species, catego ries and number of aquaculture animals kept there; 
(ii)  the type of aquaculture establishment concer ned; 
(iii)  movements of aquaculture animals into and out of the aquaculture establishment concer ned. 
2. By way of derogation from paragraph 1, Member States may exem pt from the oblig ation to apply for appro val 
operat ors of the following types of establishment: 
(a)  aquaculture establishments producing a small quantity of aquaculture animals for supply for human consump tion 
either: 
(i)  to the final consumer directly ; or 
(ii)  to local retail establishments directly supplying the final consumer; 
(b)  ponds and other installations where the population of aquatic animals is maintained only for recreational fishing 
purposes, by restoc king with aquaculture animals whic h are confined and unable to escape; 
(c)  aquaculture establishments keeping aquaculture animals for ornamental purposes in closed facilities, 
provided that the establishment in question does not pose a significant risk. 31.3.2016 L 84/118 Official Jour nal of the European Union EN     3. Unless a derog ation has been grant ed under paragraph 4 of this Article, operat ors shall not commence activity at 
an aquaculture establishment as referred to in paragraph 1 of this Article until that establishment has been appro ved in 
accordance with Article 181(1), and shall cease such activity at an aquaculture establishment refer red to in paragraph 1 
of this Article where: 
(a)  the compet ent author ity withdraws or suspends its appro val in accordance with Article 184(2); or 
(b)  in the event of conditional appro val, grant ed in accordance with Article 183(3), the aquaculture establishment 
concer ned fails to compl y with the outstanding requirements refer red to in Article 183(4) and does not obtain a 
final appro val in accordance with Article 183(3). 
4. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  derogations from the requirement for operators to apply to the compet ent author ity for appro val of the types of 
aquaculture establishments refer red to in point (a) of paragraph 1, concer ning types of establishments other than 
those specifi ed in points (a)(i) and (ii) of paragraph 2, where those establishments do not pose a signif icant risk; 
(b)  the types of aquaculture establishments which must be appro ved in accordance with point (b) of paragraph 1. 
5. When adopt ing delega ted acts as provided for in paragraph 4, the Commission shall base those acts on the 
following criteria: 
(a)  the species and categor ies of aquaculture animals kept in an aquaculture establishment ; 
(b)  the type of aquaculture establishment and the type of production; and 
(c)  typical movement patte rns of the type of aquaculture establishment concer ned and of the species or categor y of 
aquaculture animals concer ned. 
6. An operat or may apply for appro val of a group of aquaculture establishments, provided that the requirements 
provided for in points (a) and (b) of the first paragraph of Article 177 are compl ied with. 
Article 177 
Appro val by the competent author ity of groups of aquaculture establishments 
The compet ent author ity may grant appro val as provided for in Article 181(1) covering a group of aquaculture 
establishments, provided that the aquaculture establishments in question compl y with either of the following conditions: 
(a)  they are located in an epidemiologically linked area and all operat ors in that area operate under a common 
biosecur ity system ; however , any on–shore or off–shore establishment for the reception, conditioning, washing, 
cleaning, grading, wrapping and packag ing of live bivalve molluscs intended for human consump tion (so-called 
‘dispatc h centres’), establishment with tank s fed by clean seawat er in whic h live bivalve molluscs are placed for the 
time necessar y to reduce contamination to mak e them fit for human consump tion (so-called ‘pur ification centres’ ) 
and similar establishments locat ed inside such an epidemiologically linked area must be appro ved individually ; 
(b)  they are under the responsibility of the same operat or; and 
(i)  operate under a common biosecur ity system; and 
(ii)  the aquaculture animals of the establishments concer ned form part of the same epidemiological unit. 
When a sing le appro val is grant ed for a group of aquaculture establishments, the rules laid down in Article 178 and 
Articles 180 to 184 and the rules adopt ed pursuant to Articles 180(2) and 181(2), whic h are applicable to a sing le 
aquaculture establishment, shall be applicable to the whole group of aquaculture establishments. 31.3.2016 L 84/119 Official Jour nal of the European Union EN     Article 178 
Appro val of status of conf ined aquaculture establishments 
Operato rs of aquaculture establishments wishing to obtain the status of a conf ined establishment shall: 
(a)  apply to the compet ent author ity for appro val in accordance with Article 180(1); 
(b)  move aquaculture animals to or from their establishment in accordance with the requirements provided for in 
Article 203(1) and any delegat ed acts adop ted in accordance with Article 203(2) only after their establishment has 
obtained an appro val of that status from the compe tent author ity in accordance with Article 181 or 183. 
Article 179 
Appro val of disease control aquatic food establishments 
Operato rs of disease control aquatic food establishments shall: 
(a)  ensure that the necessar y appro val in accordance with Article 4 of Regulation (EC) No 853/2004 of the European 
Parliament and of the Council (1) has been obtained; and 
(b)  apply to the compet ent author ity, in accordance with Article 180(1), for appro val to slaughter or process aquatic 
animals for disease control purposes in accordance with point (b) of Article 61(1), Article 62 and Articles 68(1), 79 
and 80 and the rules adop ted pursuant to Article 63 and Articles 70(3) and 71(3). 
Article 180 
Obligation of operat ors to provide information with a view to obtainin g appro val 
1. Operato rs shall, for the purposes of their application for appro val of their establishment as provided for in 
Article 176(1), Article 177, point (a) of Article 178 and Article 179, provide the compet ent author ity with the following 
information: 
(a)  the name and address of the operator concer ned; 
(b)  the location of the establishment concer ned and a descr iption of its facilities; 
(c)  the species, categor ies and quantities (numbers, volume or weight) of aquaculture animals relevant for the appro val 
which are kept on the establishment ; 
(d)  the type of aquaculture establishment ; 
(e)  in cases of appro val of a group of aquaculture establishments, details showing that the group in question compl ies 
with the conditions laid down in Article 177; 
(f)  other aspects of the mode of operation of the aquaculture establishment in question whic h are relevant for 
determining the risk, posed by it; 
(g)  the water supply to, and disc harge of water from, the establishment ; 
(h)  the establishment's biosecur ity measures. 
2. Operato rs of establishments as refer red to in paragraph 1 shall inform the compet ent author ity in advance of: 
(a)  any chang es in the establishments concer ning the matt ers refer red to in paragraph 1; 
(b)  any cessation of activity by the operat or or establishment concer ned. 31.3.2016 L 84/120 Official Jour nal of the European Union EN     
(1)Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific hygiene rules for 
food of animal origin (OJ L 139, 30.4.2004, p. 55). 3. The Commission may, by means of implementing acts, lay down rules concer ning the information to be provided 
by operators in their application for appro val of their establishment, in accordance with paragraph 1, including the 
time-limits by which such information is to be provided. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 181 
Granting of, and conditions for, appro val and delegated acts 
1. The compet ent author ity shall only grant appro vals of aquaculture establishments as referred to in Article 176(1) 
and point (a) of Article 178, groups of aquaculture establishments as referred to in Article 177 and disease control 
aquatic food establishments as refer red to in Article 179, where such establishments: 
(a)  compl y with the following requirements, where appropr iate, in relation to: 
(i)  quarantine, isolation and other biosecur ity measures taking into account the requirements provided for in 
point (b) of Article 10(1)) and any rules adopt ed pursuant to Article 10(6); 
(ii)  surveillance requirements as provided for in Article 24, where relevant for the type of establishment concer ned 
and the risk involved, in Article 25; 
(iii)  record-kee ping as provided for in Articles 186 to 188 and any rules adop ted pursuant to Articles 189 and 190; 
(b)  have facilities and equipment that are: 
(i)  adequate to reduce the risk of the introduction and spread of diseases to an acceptab le level, taking into account 
the type of establishment concer ned; 
(ii)  of a capacity adequate for the species, catego ries and quantity (numbers, volume or weight) of aquatic animals 
concer ned; 
(c)  do not pose an unaccep table risk as regards the spread of diseases, taking into account the risk-mitig ation measures 
in place; 
(d)  have in place a system which enables the operator concer ned to demonstrate to the compet ent author ity that the 
requirements laid down in points (a), (b) and (c) are fulfilled. 
2. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  quarantine, isolation and other biosecur ity measures as referred to in point (a)(i) of paragraph 1; 
(b)  surveillance as refer red to in point (a)(ii) of paragraph 1; 
(c)  facilities and equipment as referred to in point (b) of paragraph 1. 
3. When establishing the rules to be laid down in the delegat ed acts to be adop ted pursuant to paragraph 2, the 
Commission shall base those rules on the following matt ers: 
(a)  the risks posed by each type of establishment ; 
(b)  the species and categor ies of aquaculture or aquatic animals relevant for the appro val; 
(c)  the type of production concer ned; 
(d)  typical movement patte rns of the type of aquaculture establishment and species and catego ries of animals kept in 
those establishments. 31.3.2016 L 84/121 Official Jour nal of the European Union EN     Article 182 
Scope of the appro val of establishments 
The compet ent author ity shall expressly specify in the appro val of an aquaculture establishment or a disease control 
aquatic food establishment granted pursuant to Article 181(1) following an application made in accordance with 
Article 176, Article 177, point (a) of Article 178 or Article 179: 
(a)  for whic h of the types of aquaculture establishments referred to in Article 176(1) and point (a) of Article 178, 
groups of aquaculture establishments referred to in Article 177 and disease control aquatic food establishments 
refer red to in Article 179, and in any rules adop ted pursuant to point (b) of Article 176(4), the appro val applies; 
(b)  for whic h species and catego ries of aquaculture animals the appro val applies. 
Article 183 
Procedures for the granting of appro val by the competent author ity 
1. The compet ent author ity shall establish procedures for operators to follow when applying for appro val of their 
establishments in accordance with Article 176(1) and Articles 178 and 179. 
2. Upon receipt of an application for appro val from an operat or in accordance with Article 176(1), Article 178 or 
Article 179, the compe tent author ity shall make an on–sit e visit. 
3. Provided that the requirements refer red to in Article 181 are fulfilled, the compet ent author ity shall grant the 
appro val. 
4. Where an establishment does not fulfil all requirements for appro val as referred to in Article 181, the compe tent 
author ity may grant conditional appro val of an establishment if it appears, on the basis of the application by the 
operat or concer ned and the subsequent on-site visit provided for in paragraph 2 of this Article, that the establishment 
meets all the main requirements that provide suffi cient guarantees that the establishment does not pose a signif icant 
risk. 
5. Where conditional appro val has been granted by the compet ent author ity in accordance with paragraph 4 of this 
Article, it shall grant full appro val only where it appears from another on–site visit to the establishment, carried out 
within three months from the date of the grant of conditional appro val, or from documentation provided by the 
operat or within three months from that date, that the establishment meets all the requirements for appro val provided 
for in Article 181(1) and the rules adopt ed pursuant to Article 181(2). 
Where the on–sit e visit or the documentation referred to in the first subparagraph shows that clear progress has been 
made but that the establishment still does not meet all of those requirements, the compet ent author ity may prolong the 
conditional appro val. However , conditional appro val shall not be grant ed for a period exceed ing, in total, six months. 
Article 184 
Review , suspension and withdrawal of appro vals by the competent author ity 
1. The compet ent author ity shall keep appro vals of establishments grant ed in accordance with Article 181(1) under 
review , at appropr iate intervals based on the risk involved. 
2. Where a compet ent author ity identifies serious deficiencies in an establishment as regards compl iance with the 
requirements laid down in Article 181(1) and the rules adopt ed pursuant to Article 181(2), and the operator of that 
establishment is not able to provide adequate guarant ees that those deficiencies will be eliminated, the compet ent 
author ity shall initiat e procedures to withdraw the appro val of the establishment. 
However , the compet ent author ity may merely suspend, rather than withdra w, appro val of an establishment where the 
operat or can guarant ee that it will eliminate those deficien cies within a reasonable period of time. 31.3.2016 L 84/122 Official Jour nal of the European Union EN     3. Appro val shall only be grant ed after withdrawal or restored after suspension in accordance with paragraph 2 when 
the compet ent author ity is satisfied that the establishment fully complies with all the requirements of this Regulation 
appropr iate for that type of establishment. 
Section 3 
Regist er of aquaculture establishments and disease control aquatic food 
establishments 
Article 185 
Register of aquaculture establishments and disease control aquatic food establishments 
1. Each compet ent author ity shall establish and keep up to date a register of: 
(a)  all aquaculture establishments registered in accordance with Article 173; 
(b)  all aquaculture establishments appro ved in accordance with Article 181(1); 
(c)  all disease control aquatic food establishments appro ved in accordance with Article 181(1). 
2. The register of aquaculture establishments provided for in paragraph 1 shall contain the following information: 
(a)  the name and address of the operator and the registration number of the establishment in question; 
(b)  the location of the aquaculture establishment or, as the case may be, of the group of aquaculture establishments 
concer ned; 
(c)  the type of production at the establishment ; 
(d)  the water supply to, and disc harge from, the establishment, when relevant ; 
(e)  the species of aquaculture animals kept at the establishment ; 
(f)  up–t o–date information on the health status of the registere d aquaculture establishment, or, as the case may be, of 
the group of establishments, as regards the listed diseases referred to in point (d) of Article 9(1). 
3. For establishments appro ved in accordance with Article 181(1), the compet ent author ity shall make publicly 
available by electronic means at least the information referred to in points (a), (c), (e) and (f) of paragraph 2 of this 
Article, subject to data protection requirements. 
4. Where appropr iate and relevant, a compet ent author ity may combine the registration provided for in paragraph 1 
with registration for other purposes. 
5. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the relevant detailed information to be included in the register of aquaculture establishments provided for in 
paragraph 1 of this Article; 
(b)  the public availability of that register . 
Section 4 
Record-keepin g and traceability 
Article 186 
Record-k eeping obligations of operators of aquaculture establishments 
1. Operato rs of aquaculture establishments subject to the requirement of registration in accordance with Article 173, 
or appro val in accordance with Article 181(1), shall keep and maintain records containing at least the following 
information: 
(a)  the species, categor ies and quantities (numbers, volume or weight) of aquaculture animals on their establishment ; 31.3.2016 L 84/123 Official Jour nal of the European Union EN     (b)  movements of aquaculture animals and products of animal origin obtained from those animals into and out of their 
establishment, stating as appropr iate: 
(i)  their place of origin or destination; 
(ii)  the date of such movements; 
(c)  the animal health certificates, in paper or electronic form, required to accompan y movements of aquaculture animals 
arriving at the aquaculture establishment in accordance with Article 208 and the rules adopt ed pursuant to 
points (a) and (c) of Article 211(1) and Article 213(2); 
(d)  mor tality in each epidemiological unit and other disease problems at the aquaculture establishment as relevant for 
the type of production; 
(e)  biosecur ity measures, surveillance, treatments, test results and other relevant information as appropr iate for: 
(i)  the species and catego ries of the aquaculture animals on the establishment ; 
(ii)  the type of production at the aquaculture establishment ; 
(iii)  the type and size of the aquaculture establishment ; 
(f)  the results of any animal health visits required in accordance with Article 25(1). 
The records shall be kept and maintained in paper or electronic form. 
2. Aquaculture establishments presenting a low risk of spreading listed or emerging diseases may be exem pted by the 
Member State concer ned from the requirement to keep records of all or some of the information listed in points (c), (d) 
and (e) of paragraph 1, provided that traceability is ensured. 
3. Operato rs of aquaculture establishments shall keep the records provided for in paragraph 1 on their aquaculture 
establishment concer ned and shall: 
(a)  keep them in such a way that the tracing of the place of origin and destination of aquatic animals can be guarant eed; 
(b)  make them available to the compet ent author ity on request ; 
(c)  retain them for a minimum period to be prescr ibed by the compet ent author ity, whic h may not be less than three 
years. 
By way of derogation from the requirement that the records are to be kept on their establishment concer ned, as set out 
in the first subparagraph, when it is physically not possible to keep the records on that establishment, they shall be kept 
in the office from which the business is administe red. 
Article 187 
Record-keeping obligations of disease control aquatic food establishments 
1. Operato rs of disease control aquatic food establishments subject to appro val in accordance with Article 179 shall 
keep and maintain records of: 
(a)  all movements into and from their establishment of aquaculture animals and products of animal origin obtained 
from such animals; 
(b)  disc harge of water and relevant biosecur ity measures. 31.3.2016 L 84/124 Official Jour nal of the European Union EN     2. Operato rs of disease control aquatic food establishments shall: 
(a)  keep the records provided for in paragraph 1 on their establishment and shall make them available to the compet ent 
author ity on request ; 
(b)  retain those records for a minimum period to be prescr ibed by the compet ent author ity, whic h may not be less than 
three years. 
The records shall be kept and maintained in paper or electronic form. 
Article 188 
Record-k eeping obligations of transpor ters 
1. Transpor ters of aquatic animals intended for aquaculture establishments or to be released into the wild shall keep 
and maintain records in relation to: 
(a)  the species, categor ies and quantities (numbers, volume or weight) of aquatic animals transpor ted by them; 
(b)  mor tality rates of the aquaculture animals and wild aquatic animals in question during transpor t, in so far as is 
practicable for the type of transpor t and the species of aquaculture animals and wild aquatic animals transpor ted; 
(c)  aquaculture establishments and disease control aquatic food establishments visited by the means of transpor t; 
(d)  any exchang e of wate r that took place during transpor t, specifying the sources of new water and sites of release of 
water; 
(e)  the cleaning and disinf ection of the means of transpor t. 
The records shall be kept and maintained in paper or electronic form. 
2. Transpor ters presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State 
concer ned from the requirement to keep records of all or some of the information listed in paragraph 1, provided that 
traceability is ensured. 
3. Transpor ters shall keep the records provided for in paragraph 1: 
(a)  in such a manner that they can be made immediate ly available to the compet ent author ity on request ; 
(b)  for a minimum period to be prescr ibed by the compet ent author ity, which may not be less than three years. 
Article 189 
Delegation of powers concer ning record-keeping 
1. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning rules 
supplementing the record-k eeping requirements provided for in Articles 186, 187 and 188, as regards information to be 
recorded by operat ors in addition to that provided for in Articles 186(1), 187(1) and 188(1). 
2. The Commission shall take the following matt ers into account when adopting the deleg ated acts provided for in 
paragraph 1: 
(a)  the risks posed by each type of aquaculture establishment or transpor t; 
(b)  the species and catego ries of aquatic animals kept on the aquaculture establishment concer ned, or transpor ted to or 
from that establishment ; 
(c)  the type of production of the establishment ; 
(d)  typical movement patt erns for the type of aquaculture establishment or disease control aquatic food establishment ; 
(e)  the numbers, volume or weight of aquatic animals kept on the establishment or transpor ted to or from it. 31.3.2016 L 84/125 Official Jour nal of the European Union EN     Article 190 
Implementing powers concer ning exemp tions from the record-keepin g requirements 
The Commission may, by means of implementing acts, lay down rules concer ning the types of aquaculture 
establishments and operators that may be exem pted by Member State s from the record-keeping requirements provided 
for in Articles 186 and 188, as regards: 
(a)  operat ors of certain catego ries of aquaculture establishments and transpor ters; 
(b)  aquaculture establishments keeping, or transpor ters transpor ting, respectively , a small number of aquaculture 
animals or a small number of aquatic animals; 
(c)  certain species and categor ies of aquatic animals. 
When adopting those implementing acts, the Commission shall base those acts on the criteria provided for in 
Article 189(2). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 2 
Mov ements within the Union of aquatic animals 
Section 1 
General requirements for mo vements 
Article 191 
General requirements for movements of aquatic animals 
1. Operato rs shall take appropr iate measures to ensure that the movement of aquatic animals does not jeopardise the 
health status at the place of destination with regar d to: 
(a)  the liste d diseases referred to in point (d) of Article 9(1); 
(b)  emerging diseases. 
2. Operato rs shall only move aquatic animals into an aquaculture establishment or for human consump tion 
purposes, or release them into the wild, if the animals in question fulfil the following conditions: 
(a)  they come, excep t in the case of wild aquatic animals, from establishments that have been: 
(i)  register ed by the compet ent author ity in accordance with Article 173, 
(ii)  appro ved by that compet ent author ity in accordance with Articles 181 and 182, when required by 
Article 176(1), Article 177 or Article 178, or 
(iii)  grant ed a derogation from the registration requirement laid down in Article 173. 
(b)  they are not subject to: 
(i)  movement restr ictions affecting the species and categor ies concer ned in accordance with the rules laid down in 
Article 55(1), Article 56, Article 61(1), Articles 62, 64 and 65, point (b) of Article 70(1), Article 74(1), 
Article 79 and Article 81 and the rules adop ted pursuant to Article 55(2), Articles 63 and 67 and Articles 70(3), 
71(3), 74(4) and 83(2); or 
(ii)  the emergency measures laid down in Articles 257 and 258 and the rules adopt ed pursuant to Article 259. 
However , operat ors may move those aquatic animals where derogations from the movement restr ictions for such 
movements or release are provided for in Title II of Part III (Articles 53–83) or derogations from emerge ncy measures 
are provided for in rules adopt ed pursuant to Article 259. 31.3.2016 L 84/126 Official Jour nal of the European Union EN     3. Operato rs shall take all necessar y measures to ensure that aquatic animals, after leav ing their place of origin, are 
consigned directly to the final place of destination. 
Article 192 
Disease prev ention measures in relation to transpor t 
1. Operato rs shall take the appropr iate and necessar y disease prevention measures to ensure that: 
(a)  the health status of aquatic animals is not jeopardised during transpor t; 
(b)  transpor t operations of aquatic animals do not cause the poten tial spread of listed diseases as refer red to in point (d) 
of Article 9(1) to humans or animals en route, and at places of destination; 
(c)  cleaning and disinfection of equipment and means of transpor t and other adequate biosecur ity measures are taken, 
as appropr iate to the risks involved with the transpor t operations concer ned; 
(d)  any exchange s of water and disc harge s of water during the transpor t of aquatic animals intended for aquaculture or 
release into the wild are carried out at places and under conditions which do not jeopardise the health status with 
regard to the liste d diseases referred to in point (d) of Article 9(1) of: 
(i)  the aquatic animals being transpor ted; 
(ii)  any aquatic animals en route to the place of destination; 
(iii)  aquatic animals at the place of destination. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the conditions and requirements for cleaning and disinfection of equipment and means of transpor t in accordance 
with point (c) of paragraph 1 of this Article and the use of biocidal products for such purposes; 
(b)  other appropr iate biosecur ity measures during transpor t as provided for in point (c) of paragraph 1 of this Article; 
(c)  water exchang es and discharg es of water during transpor t as provided for in point (d) of paragraph 1 of this Article. 
Article 193 
Change of intended use 
1. Aquatic animals whic h are moved for destr uction or slaughter in accordance with the following measures shall not 
be used for any other purpose: 
(a)  any of the disease control measures provided for in point (c) of Article 32(1) and Article 55(1), Articles 56, 61, 62, 
64, 65 and 70, Articles 74(1) and (2) and Articles 79, 80, 81 and 82 and in the rules adopt ed pursuant to 
Article 55(2), Articles 63 and 67, Articles 70(3), 71(3) and 74(4), and Article 83(2); 
(b)  emerge ncy measures as provided for in Articles 257 and 258 and in rules adopt ed pursuant to Article 259. 
2. Aquatic animals moved for human consump tion, aquaculture, release into the wild or any other purpose, shall not 
be used for any purpose other than the intended one. 
3. By way of derogation from paragraph 2, the compet ent author ity of the place of destination may author ise a 
change of use of aquatic animals for a purpose other than that originally intende d, provided that the new use does not 
pose a higher risk to the health status of the aquatic animals at the place of destination than the originally intende d use. 31.3.2016 L 84/127 Official Jour nal of the European Union EN     Article 194 
Obligations of operat ors at the place of destination 
1. Operato rs of aquaculture establishments and disease control aquatic food establishments receiving aquatic animals 
and operat ors receiving aquatic animals for release into the wild shall, before the aquatic animals are unloaded: 
(a)  check that, where required, one of the following documents is present: 
(i)  the animal health certificates provided for in Article 208(1), Article 209 and Article 223(1) and in the rules 
adopt ed pursuant to Articles 189, 211 and 213; 
(ii)  the self–declaration documents provided for in Article 218(1) and in the rules adop ted pursuant to 
Article 218(3) and (4); 
(b)  inform the compet ent author ity of the place of destination, after checking the aquatic animals received, of any 
irregular ity with regard to: 
(i)  the aquatic animals received; 
(ii)  the documents referred to in point (a)(i) and (ii). 
2. In the event of any irregular ity as refer red to in point (b) of paragraph 1, the operator shall isolate the aquatic 
animals concer ned by that irregular ity until the compet ent author ity of the place of destination has take n a decision 
regar ding them. 
Article 195 
General requirements in respect of movements of aquaculture animals passing through Member 
States but intended for expor t from the Union to third countr ies or territor ies 
Operato rs shall ensure that aquaculture animals intended for expor t to a third countr y or territory and passing through 
the territory of another Member State fulfil the requirements laid down in Articles 191, 192 and 193. 
Section 2 
Aqu atic animals intended for aquaculture establishments or release into the wild 
Article 196 
Abnor mal mor talities or other serious disease symptoms 
1. Operato rs shall only move aquatic animals from an aquaculture establishment or from the wild to another 
aquaculture establishment, or release them into the wild, if the animals in question: 
(a)  show no disease symp toms ; and 
(b)  originate from an aquaculture establishment or environment where there are no abnor mal mor talities with an 
undeterm ined cause. 
2. By way of derogation from paragraph 1, the compet ent author ity may, on the basis of an evaluation of the risks 
involved, author ise the movement or release of aquatic animals as referred to in that paragraph, provided that the 
animals in question originate from a part of the aquaculture establishment or from the wild that is independent of the 
epidemiological unit where the abnor mal mor talities or other disease symp toms have occur red. 
If the movement or release refer red to in this paragraph is to be made to another Member State, it shall only be 
author ised by the compet ent author ity if the compe tent author ities of the Member State of destination and, where 
relevant, of the Member States of passage have given their consent to such movement or release. 31.3.2016 L 84/128 Official Jour nal of the European Union EN     Article 197 
Movements of aquaculture animals intended for Member States, zones or compar tments which 
have been declared disease-free or which are subject to an eradication prog ramme, and delegated 
acts 
1. Operato rs shall only move aquaculture animals of liste d species relevant for one or more of the listed diseases 
referred to in points (b) or (c) of Article 9(1) to an aquaculture establishment, or for release into the wild, in a Member 
State, zone or compar tment whic h has been declared free of those liste d diseases in accordance with Article 36(4) or 
37(4), if the animals in question originat e from a Member State, or a zone or compar tment thereof, which has been 
declared free of those diseases. 
2. Operato rs shall only move aquaculture animals of liste d species relevant for one or more of the listed diseases 
referred to in points (b) or (c) of Article 9(1) to an aquaculture establishment, or for release into the wild, in a Member 
State, zone or compar tment subject to an eradication programme for one or more of those listed diseases as provided 
for in Article 31(1) or (2), if the animals in question originate from a Member State , or a zone or compar tment thereof, 
whic h has been declared free of those liste d diseases. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
derogat ions from the movement or release requirements laid down in paragraphs 1 and 2 of this Article which do not 
pose a signif icant risk for the spread of listed diseases as refer red to in point (d) of Article 9(1) on account of: 
(a)  the species, categor ies, and life stage of the aquaculture animals concer ned; 
(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-mitig ation measures applied at the place of origin or 
destination. 
Article 198 
Derogations by Member States concer ning the obligation of operators for movement of 
aquaculture animals betw een Member States, zones or compar tments which are subject to an 
eradication prog ramme 
By way of derogat ion from Article 197(1) and (2), Member States may author ise operat ors to move aquaculture animals 
into a zone or compar tment for which an eradication programme has been established in accordance with Article 31(1) 
and (2) as regards the liste d diseases refer red to in points (b) and (c) of Article 9(1), from another zone or compar tment 
for whic h 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 compar tment of destination. 
If such movements are to be made to another Member State, the compe tent author ity shall only author ise them if the 
compet ent author ities of the Member State of destination and, where relevant, of the Member States of passage , have 
given their consent to them. 
Article 199 
Member States' measures concer ning the release of aquatic animals into the wild 
Member States may require that aquatic animals may be released into the wild only if they originate from a Member 
State, or a zone or compar tment thereof, which has been declared disease–free in accordance with Article 36(1) or 
Article 37(1) as regards one or more of the liste d diseases refer red to in points (b) and (c) of Article 9(1) for which the 
species of aquatic animals to be moved is a liste d species, regar dless of the health status of the area where those aquatic 
animals are to be released. 31.3.2016 L 84/129 Official Jour nal of the European Union EN     Article 200 
Movements of wild aquatic animals intended for Member States, or zones or compar tments 
thereof, which have been declared disease–free or which are subject to an eradication prog ramme, 
and delegated acts 
1. Articles 196, 197 and 198 shall apply to movements of wild aquatic animals intended for an aquaculture 
establishment or for release into the wild. 
2. Operato rs shall take the appropr iate and necessar y disease prevention measures when moving wild aquatic animals 
between habitats to ensure that: 
(a)  such movements do not pose a significant risk for the spread of listed diseases as refer red to in point (d) of 
Article 9(1) to aquatic animals at the place of destination; and 
(b)  risk-mitigation or other adequate biosecur ity measures are in place where necessar y to ensure compl iance with 
point (a). 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
disease prevention and risk-mitig ation measures to be taken by operators as provided for in paragraph 2 of this Article. 
Pending the adopt ion of such delegat ed acts, the compet ent author ity of the place of destination may decide on such 
measures. 
Section 3 
Aquatic animals intended for human consumption 
Article 201 
Movements of live aquaculture animals intended for human consumption in Member States, or in 
zones or compar tments thereof, which have been declared disease–free or which are subject to an 
eradication prog ramme, and delegated acts 
1. Operato rs shall only move live aquaculture animals of listed species relevant for liste d diseases as refer red to in 
points (b) or (c) of Article 9(1) intended for human consump tion to a Member State, or to a zone or compar tment 
thereof, whic h has been declared disease-free in accordance with Article 36(4) or Article 37(4) or for which a 
eradication programme has been established in accordance with Article 31(1) or (2), as regar ds one or more of the listed 
diseases refer red to in points (b) and (c) of Article 9(1), if the animals in question originate from a Member State , or a 
zone or compar tment thereof, which has been declared disease–free in accordance with Article 36(4) or Article 37(4). 
2. By way of deroga tion from paragraph 1 of this Article, Member States may author ise operat ors to introduce live 
aquaculture animals into a zone or compar tment for which an eradication programme has been established in 
accordance with Article 31(1) or (2) as regards the listed diseases referred to in points (b) and (c) of Article 9(1), from 
another zone or compar tment for whic h 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 of 
the zone or compar tment thereof. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
derogat ions provided for in paragraph 2 of this Article in respect of movements of live aquaculture animals whic h do 
not pose a signif icant risk of spreading of diseases on account of: 
(a)  the species, categor ies, and live stage of the aquaculture animals concer ned; 
(b)  the methods of keeping the aquaculture animals and the 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; 31.3.2016 L 84/130 Official Jour nal of the European Union EN     (e)  treatments, processing methods and other special risk-mitigation measures applied at the place of origin or the place 
of destination. 
Article 202 
Movements of live wild aquatic animals intended for Member States, or zones or compar tments 
thereof, which have been declared disease–free or which are subject to an eradication prog ramme, 
and delegated acts 
1. Article 201(1) and (2) and the rules adopt ed pursuant to Article 201(3) shall apply to movements of live wild 
aquatic animals intended for human consum ption and which are intended for Member States, or zones or compar tments 
thereof, which have been declared disease–free in accordance with Articles 36(4) or 37(4) or which are subject to an 
eradication programme in accordance with Article 31(1) or (2), where the measures adopt ed pursuant thereto are 
necessar y in order to ensure that the animals in question do not pose a significant risk for the spread of listed diseases 
as refer red to in point (d) of Article 9(1) to aquatic animals at the place of destination. 
2. Paragraph 1 of this Article shall also apply to live aquatic animals not covered by the definit ion of aquaculture 
animals contained in Article 4(7). 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
movement requirements for wild aquatic animals intended for human consum ption, supplementing paragraphs 1 and 2 
of this Article. 
Section 4 
Derogations from Sections 1 to 3 (Ar ticles 191 to 202) and additional risk- 
mitigation measures 
Article 203 
Aquatic animals intended for conf ined establishments for aquaculture and delegated acts 
1. Operato rs shall only move aquatic animals to a conf ined establishment for aquaculture if the animals in question 
fulfil the following conditions: 
(a)  they originate from another confined establishment for aquaculture; 
(b)  they do not pose a significant risk for the spread of liste d diseases as referred to in point (d) of Article 9(1) to listed 
species of animals at the conf ined establishment for aquaculture of destination, excep t where the movement in 
question is author ised for scientifi c purposes. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  detailed rules for movements of aquaculture animals to conf ined establishments for aquaculture in addition to those 
provided for in paragraph 1 of this Article; 
(b)  specifi c rules for movements of aquaculture animals to conf ined establishments for aquaculture where the risk- 
mitig ation measures in place guarant ee that such movements do not pose a signif icant risk for the health of 
aquaculture animals within that confined establishment for aquaculture and the surrounding establishments. 
Article 204 
Movements of aquatic animals for scientif ic pur poses and delegated acts 
1. The compet ent author ity of the place of destination may, subject to the agreement of the compet ent author ity of 
the place of origin, author ise movements of aquatic animals into the territory of the Member State of destination, for 
scientific purposes, where those movements do not fulfil the requirements of Sections 1 to 3 (Articles 191 to 202), with 
the excep tion of Article 191(1) and (3) and Articles 192, 193 and 194. 31.3.2016 L 84/131 Official Jour nal of the European Union EN     2. The compet ent author ity referred to in paragraph 1 shall only grant derogat ions as provided for in that paragraph 
under the following conditions: 
(a)  the compet ent author ities of the places of destination and origin: 
(i)  have agreed on the conditions for such movements; 
(ii)  ensure that the necessar y risk-mitig ation measures are in place so that movements of the aquatic animals in 
question do not jeopardise the health status in places en route and in the places of destination with regard to 
the listed diseases refer red to in point (d) of Article 9(1); 
(iii)  have notified , where relevant, the compet ent author ities of the Member States of passage of the derog ation 
grant ed and of the conditions under whic h it is grant ed; 
(b)  those movements take place under the super vision of the compet ent author ities of the places of origin and 
destination, and where relevant, the compet ent author ities of the Member State s of passage. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning rules for 
the granting of derogat ions by compet ent author ities, supplementing those provided for in paragraphs 1 and 2 of this 
Article. 
Article 205 
Other specif ic uses of aquatic animals, specif ic requirements and derogations and delegation of 
powers 
1. Operato rs shall take the necessar y preventive measures to ensure that movements of aquatic animals intende d for 
the specific purposes or uses listed in point (a)(i) to (vi) of paragraph 2 of this Article do not pose a risk for the spread 
of listed diseases as referred to in point (d) of Article 9(1) to aquatic animals at the place of destination. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  specifi c requirement supplementing the rules laid down in Sections 1 to 3 (Articles 191 to 202) and for movements 
of aquatic animals for the following purposes: 
(i)  zoos, pet shops, wholesalers and garden ponds; 
(ii)  exhibitions; 
(iii)  spor ts fishing, including fishing baits; 
(iv)  cultural and similar events; 
(v)  commercial aquar ia; or 
(vi)  health care and other similar uses. 
(b)  derogations from Sections 1 to 3 (Articles 191 to 202) with the excep tion of Article 191(1) and (3) and 
Articles 192, 193 and 194 for the movements of aquatic animals referred to in point (a) of this paragraph, provided 
that adequate biosecur ity provisions are in place to ensure that those movements do not pose a signif icant risk to 
the health status of the place of destination. 
Article 206 
Implementing power to adopt temporar y rules for movements of specif ic species or categor ies of 
aquatic animals 
1. The Commission may, by means of implementing acts, lay down temporar y rules, by way of addition or alternati ve 
to those laid down in this Chapt er, for movements of specif ic species or catego ries of aquatic animals where: 
(a)  the movement requirements provided for in Article 196, Article 197(1), Articles 198 and 199, Article 200(1) 
and (2), Article 201 and Articles 202(1), 203(1), 204(1) and (2) and the rules adopt ed pursuant to Articles 197(3), 
200(3), 202(3), 203(2) and 204(3) and Article 205 do not efficiently mitigat e the risks posed by the movement of 
those aquatic animals; or 31.3.2016 L 84/132 Official Jour nal of the European Union EN     (b)  a listed disease as refer red to in point (d) of Article 9(1) appears to be spreading despite the movement requirements 
laid down in accordance with Sections 1 to 4 (Articles 191 to 207). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
2. On duly justif ied imperative grounds of urgency relating to a listed disease representing a risk of a highly 
signif icant impa ct and taking into account the matters refer red to in Article 205, the Commission shall adopt 
immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3). 
Article 207 
Matters to be taken into account in the adoption of delegated and implementing acts as provided 
for in this Section 
When establishing the rules to be laid down in the delegat ed and implementing acts provided for in Article 203(2), 
Article 204(3) and Articles 205 and 206, the Commission shall base those rules on: 
(a)  the risks involved with the movements refer red to in those provisions; 
(b)  the health status as regards the listed diseases refer red to in point (d) of Article 9(1) at the places of origin, passage 
and destination; 
(c)  liste d aquatic animal species for the listed diseases refer red to in point (d) of Article 9(1); 
(d)  biosecur ity measures in place at the places of origin, passage and destination; 
(e)  any specific conditions under whic h the aquaculture animals are kept; 
(f)  specifi c movement patte rns of the type of aquaculture establishment and the species or catego ry of aquatic animals 
concer ned; 
(g)  other epidemiological factors. 
Section 5 
Animal health cer tification 
Article 208 
Obligation of operat ors to ensure that aquaculture animals are accompanied by an animal health 
certificate 
1. Operato rs shall only move aquaculture animals if they are accompan ied by an animal health certificate issued by 
the compe tent author ity of the Member State of origin in accordance with Article 216(1), where the animals in question 
are of liste d species for the listed diseases refer red to in points (b) and (c) of Article 9(1) and are intended for 
introduction into a Member State , or a zone or compar tment thereof, whic h has been declared disease–free in 
accordance with Articles 36(4) and 37(4) or for which an eradication programme has been established as provided for 
in Article 31(1) or (2) as regards one or more of the listed diseases refer red to in points (b) and (c) of Article 9(1). 
2. Operato rs shall only move aquaculture animals if they are accompan ied by an animal health certificate issued by 
the compe tent author ity of the Member State of origin in accordance with Article 216(1), where the animals in question 
are of listed species for the relevant disease(s) refer red to in points (a) and (b) of Article 9(1) and are allowed to leav e a 
restr icted zone subject to disease control measures as provided for in point (f)(ii) of Article 55(1), Articles 56 and 64 or 
Articles 65(1), 74(1), 79 and rules adop ted pursuant to Article 55(2), Articles 67 and 68, Articles 71(3), 74(4) and 83(2) 
and Article 259 for one or more of the listed diseases refer red to in points (a) and (b) of Article 9(1). 
3. Operato rs shall take all necessar y measures to ensure that the animal health certificate accompan ies the 
aquaculture animals from their place of origin to their final place of destination, unless specifi c measures are provided 
for in rules adopt ed pursuant to Article 214. 31.3.2016 L 84/133 Official Jour nal of the European Union EN     Article 209 
Obligation of operators to ensure that other aquatic animals are accompanied by an animal health 
certificate and implementing power 
1. In cases where, due to the risk involved with the movement of aquatic animals other than aquaculture animals, 
animal health certification is required in accordance with the rules provided for in point (a) of Article 211(1), operat ors 
shall only move those aquatic animals if the animals in question are accompan ied by an animal health certificate issued 
by the compet ent author ity of the Member State of origin in accordance with Article 216(1). 
2. Article 208 shall also apply to aquatic animals other than aquaculture animals intende d for an aquaculture 
establishment or release into the wild. Where the compet ent author ity of the Member State of origin concludes that 
certification is not feasible due to the nature of the place of origin of the aquatic animals in question, it may author ise 
their movement without an animal health certificate subject to the consent of the compet ent author ity of the place of 
destination. 
3. This Article shall not apply to wild aquatic animals harvested or caught for direct human consump tion. 
Article 210 
Grant of derogations by Member States in respect of national animal health certification 
By way of derogation from the animal health certification requirements laid down in Articles 208 and 209, Member 
States may grant derogations for movements of certain consignments of aquatic animals without an animal health 
certificate within their territori es provided that they have in place an alternati ve system to ensure that consignments of 
such animals are traceable and those consignments compl y with the animal health requirements for such movements 
provided for in Sections 1 to 4 (Articles 191 to 207). 
Article 211 
Delegation of powers and implementing acts concer ning animal health certification in respect of 
aquatic animals 
1. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the requirement for animal heath certification for movements of aquatic animals other than aquaculture animals as 
refer red to in Article 209(1), in cases where animal health certification is imperativ e in order to ensure that the 
movement in question compl ies with the following animal health requirements for the listed species of animals 
concer ned: 
(i)  the requirements provided for in Sections 1 to 4 (Articles 191 to 207) and the rules adopt ed pursuant to those 
Sections; 
(ii)  disease control measures as provided for in Article 55(1), Article 56, Article 61(1), Articles 62 and 64, and 
Article 65(1), Article 74(1), and Articles 79 and 80 or the rules adop ted pursuant to Article 55(2), Articles 63, 
67 and 68, and Articles 71(3), 74(4) and 83(2); 
(iii)  emerg ency measures as provided for in the rules adopt ed pursuant to Article 259; 
(b)  special rules for animal health certificat ion as provided for in Articles 208 and 209 where specif ic risk-mitigation 
measures are taken by the compet ent author ity to ensure: 
(i)  the traceability of the aquatic animals being moved; 31.3.2016 L 84/134 Official Jour nal of the European Union EN     (ii)  that the aquatic animals being moved fulfil the animal health requirements for movements provided for in 
Sections 1 to 4 (Articles 191 to 207); 
(c)  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 whic h do not pose a signif icant risk of the spread of 
diseases, on account of: 
(i)  species, the catego ries or live stage of the aquatic animals concer ned; 
(ii)  the methods of keeping and the type of production of those species and catego ries of aquaculture animals; 
(iii)  the intende d use of the aquatic animals; or 
(iv)  the place of destination of the aquatic animals. 
2. The Commission shall, by means of implementing acts, lay down rules concer ning the oblig ation of operat ors, as 
provided for in Article 209(2), to ensure that wild aquatic animals intended for an aquaculture establishment are 
accompan ied by an animal health certificate. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 212 
Contents of animal health certificates 
1. The animal health certificate refer red to in Articles 208, 209 and 210 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 rout e; 
(b)  a descr iption, including the species and categor y, of the aquatic animals concer ned; 
(c)  the quantity (number , volume or weight) of aquatic animals; 
(d)  the information needed to demonstrate that the aquatic animals fulfil the relevant animal health requirements in 
respect of movements provided for in Sections 1 to 4 (Articles 191 to 207). 
2. The animal health certificate may include other information required under other Union legislation. 
Article 213 
Delegation of powers and implementing acts concer ning the content of animal health certificates 
1. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning the conte nt of animal 
health certificates as provided for in Article 212(1): 
(a)  detailed rules on the cont ent of those animal health certificates provided for in Article 212(1) for differ ent species 
and catego ries 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 concer ning the model forms for the animal 
health certificates. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 31.3.2016 L 84/135 Official Jour nal of the European Union EN     Article 214 
Delegation of powers concer ning specif ic types of movements of aquatic animals to the place of 
destination 
The Commission shall be emp owered to adopt delegat ed acts in accordance with Article 264 concer ning specifi c 
measures supplementing the requirements for animal health certification provided for in Article 208 and 209 for the 
following types of movements of aquatic animals: 
(a)  movements of aquatic animals which are required to retur n to their place of origin or to be moved to a different 
destination, for one or more of the following reasons: 
(i)  their intended jour ney was unexpectedly interr upted for animal welf are reasons; 
(ii)  unforeseen accidents or events during the jour ney; 
(iii)  they were rejecte d at the place of the destination in another Member State or at the extern al border of the 
Union; 
(iv)  they were rejected in a third countr y or territory; 
(b)  movements of aquaculture animals intended for exhibitions and for spor ting, cultural and similar events, and their 
subsequent retur n to their place of origin. 
Article 215 
Operato rs' obligations to cooperate with the competent author ities for the pur poses of animal 
health certification 
Operato rs shall: 
(a)  provide the compe tent author ity with all the information necessar y to compl ete the animal health certificate 
provided for in Articles 208 and 209 and in the rules adopt ed pursuant to Articles 211, 213 and 214, in advance of 
the intended movement ; 
(b)  where necessar y, ensure that the aquatic animals in question are subjected to documentar y, identity and physical 
checks as provided for in Article 216(3) and in the rules adopt ed pursuant to Article 216(4). 
Article 216 
Responsibility of the competent author ity for animal health certification and delegated acts 
1. The compet ent author ity shall, upon request by an operat or, issue an animal health certificate for the movement of 
aquatic animals, where required by Articles 208 and 209, or by rules adopt ed pursuant to Articles 211 and Article 214, 
provided that the following animal health requirements have been compl ied with, as relevant: 
(a)  those provided for in Article 191, Article 192(1), Articles 193, 195 and 196, Article 197(1), Articles 198 and 199, 
Article 200(1) and (2), Article 201, Article 203(1) and Article 204(1) and (2); 
(b)  those provided for in delegat ed acts adopt ed pursuant to Articles 192(2), 197(3), 200(3), 201(3), 202(3), 203(2) and 
204(3) and Article 205; 
(c)  those provided for in implementing acts adopt ed pursuant to Article 206. 31.3.2016 L 84/136 Official Jour nal of the European Union EN     2. Animal health certificates shall: 
(a)  be verified, stam ped and signed by an official veterinar ian; 
(b)  remain valid for the period of time, provided for in the rules adopt ed pursuant to point (c) of paragraph 4, during 
which the aquatic animals covered by it must continue to fulfil the animal health guarantees contained in it. 
3. Before signing an animal health certificate, the official veteri narian concer ned shall verify, by means of 
documentar y, identity and physical chec ks as provided for by delegat ed acts adop ted pursuant to paragraph 4 where 
appropr iate, that the aquatic animals covered by it fulfil the requirements of this Chapt er, taking into account the species 
and cate gories of aquatic animals concer ned and the animal health requirements. 
4. The Commission shall adopt delegat ed acts in accordance with Article 264 laying down rules concer ning: 
(a)  the types of documentar y, identity and physical chec ks and examinations in relation to different species and 
catego ries of aquatic animals that must be carried out by the official veterinar ian in accordance with paragraph 3 in 
order to verify compl iance with the requirements of this Chapt er; 
(b)  the timeframes for the carrying-out of such documentar y, identity and physical checks and examinations, and the 
issuing of animal health certificates by the official veteri narian prior to the movement of consignments of aquatic 
animals; 
(c)  the duration of the validity of animal health certificates. 
Article 217 
Electronic animal health certificates 
Electronic animal health certificates, produced, handled and transmitted by means of Traces, may replace accompan ying 
animal health certificates as provided for in Article 216(1) where such electronic animal health certificates: 
(a)  contain all the information that the model form of animal health certificate is required to contain in accordance 
with Article 212(1) and the rules adopt ed pursuant to Article 213; 
(b)  ensure the traceability of the aquatic animals in question and the link between those animals and the electronic 
animal health certificate; 
(c)  ensure that the compet ent author ities of the Member States of origin, passage and destination are able to have access 
to the electronic documents at all times during the transpor t. 
Article 218 
Self–declaration by operators for movements of aquaculture animals to other Member States and 
delegated acts 
1. Operato rs 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 their place of destination in another Member State , and shall ensure 
that it accompan ies such aquaculture animals, where they are not required to be accompanied by an animal health 
certificate as provided for in Articles 208 and 209 or in any rules adopt ed pursuant to Articles 211 and Article 214. 
2. The self–declaration document provided for in paragraph 1 shall contain at least the following information 
concer ning the aquaculture animals in question: 
(a)  their places of origin and destination, and, when relevant, any places en route; 
(b)  the means of transpor t 
(c)  a descr iption of the aquaculture animals, and their categor ies, species and quantity (numbers, volume or weight), as 
relevant for the animals concer ned; 31.3.2016 L 84/137 Official Jour nal of the European Union EN     (d)  the information needed to demonstrate that the aquaculture animals fulfil the movement requirements provided for 
in Sections 1 to 4 (Articles 191 to 207). 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  detailed rules on the content of the self–declaration document provided for in paragraph 2 of this Article for 
differ ent species and categor ies 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. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Section 6 
Notif ication of mo vements of aquatic animals to other Member Sta tes 
Article 219 
Obligation of operat ors concer ning the notif ication of movements of aquatic animals to other 
Member States 
1. Operato rs other than transpor ters shall notify the compet ent author ity in their Member State of origin in advance 
of intende d movements 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 compet ent 
author ity of the Member State of origin in accordance with Articles 208 and 209 and any rules adopt ed 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 restr icted zone as refer red to in Article point (a) of 208(2); 
(c)  the aquaculture animals and wild aquatic animals being moved are intended for: 
(i)  an establishment subject to registration in accordance with Article 173 or appro val in accordance with 
Articles 176 to 179; 
(ii)  release into the wild; 
(d)  notificati on is required in accordance with delegat ed acts adop ted pursuant to Article 221. 
2. For the purposes of the notifi cation provided for in paragraph 1 of this Article, operat ors shall provide the 
compet ent author ity of their Member State of origin with all the necessar y information to enable it to notify the 
movement to the compet ent author ity of the Member State of destination in accordance with Article 220(1). 
Article 220 
Responsibility of the competent author ity to notify movements of aquatic animals to other 
Member States 
1. The compet ent author ity of the Member State of origin shall notify the compet ent author ity of the Member State 
of destination of movements of aquatic animals as refer red to in Article 219, unless a derogation has been granted in 
accordance with point (c) of Article 221(1) as regards such notification. 
2. The notifi cation refer red to in paragraph 1 shall be carried out prior to the movement in question and, whenever 
possible, through Traces. 
3. Member States shall designat e regions for the managemen t of notifications of movements as provided for in 
paragraph 1. 31.3.2016 L 84/138 Official Jour nal of the European Union EN     4. By way of derogation from paragraph 1, the compet ent author ity of Member State of origin may author ise the 
operat or concer ned to notify , partially or compl etely , movements of aquatic animals through Traces to the compet ent 
author ity of the Member State of destination. 
Article 221 
Delegation of powers and implementing acts for the notif ication of movements of aquatic animals 
by operat ors and by the competent author ity 
1. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  the requirement for advance notificati on by operat ors, in accordance with Article 219, of movements between 
Member State s of aquatic animals of species or categor ies other than those refer red to in points (a), (b) and (c) of 
Article 219(1), where traceability of such movements is necessar y in order to ensure compliance with the animal 
health requirements laid down in this Chapt er; 
(b)  the information needed in order to notify movements of aquatic animals as provided for in Articles 219 and 220(1); 
(c)  derogations from the notificati on requirements provided for in point (c) of Article 219(1) for species and categor ies 
of aquatic animals or types of movements which pose an insignif icant risk; 
(d)  the emergency procedures for notification of movements of aquatic animals in the event of power cuts or other 
disturbances of Traces; 
(e)  the requirements for the designation of regions by Member States as provided for in Article 220(3). 
2. The Commission may, by means of imp lementing acts, lay down rules concer ning: 
(a)  the details of notifications by: 
(i)  operators to the compet ent author ity of the Member State of origin of movements of aquatic animals in 
accordance with Article 219; 
(ii)  the compe tent author ity 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 provision by operat ors of the necessar y information refer red to in Article 219(2) to the compet ent author ity 
of the Member State of origin; 
(ii)  the notifi cation of movements by the compet ent author ity of the Member State of origin as referred to in 
Article 220(1). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 3 
Production, processing and distr ibution within the Union of produ cts of animal origin from aquatic 
animals, other than live aquatic animals 
Article 222 
General animal health obligations for operators and delegated acts 
1. Operato rs shall take appropr iate preventive measures to ensure that, during all stages of the production, processing 
and distr ibution of products of animal origin from aquatic animals, other than live aquatic animals, those products do 
not cause the spread of: 
(a)  liste d diseases as refer red to in point (d) of Article 9(1), taking into account the health status of the place of 
production, processing and destination; 31.3.2016 L 84/139 Official Jour nal of the European Union EN     (b)  emerging diseases. 
2. Operato rs shall ensure that products of animal origin from aquatic animals, other than live aquatic animals, do not 
come from establishments or food businesses, or are not obtained from animals which come from such establishments 
or food businesses, that are subject to: 
(a)  emerge ncy measures as provided for in Articles 257 and 258 and any rules adopt ed pursuant to Article 259, unless 
derogations have been provided for in respect of those rules in Part VII (Articles 257 to 262); 
(b)  movement restr ictions applicable to aquatic animals and products of animal origin from aquatic animals, as 
provided for in point (c) of Article 32(1), point (e) of Article 55(1), Article 56, point (a) of Article 61(1), 
Article 62(1), point (c) of Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1), point (b) of 
Article 76(2), Article 76(3), Article 79, Article 81 and Article 82(2) and (3) and the rules adop ted pursuant to 
Article 55(2), Articles 63 and 67, and Articles 70(3), 71(3), 74(4), 76(5) and 83(2), unless derogation from those 
movement restr ictions have been provided for in those rules. 
3. The Commission shall adop t delegat ed acts in accordance with Article 264 concer ning detailed requirements 
supplementing those refer red to in paragraph 2 of this Article in relation to movements of products of animal origin 
from aquatic animals other than live aquatic animals, as regards: 
(a)  the diseases, and species of aquatic animals concer ned by the diseases, for whic h emerg ency measures or movement 
restr ictions as referred to in paragraph 2 of this Article apply ; 
(b)  the types of products of animal origin from aquatic animals; 
(c)  the risk-mitig ation 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. 
4. This Article shall not apply to products of animal origin from wild aquatic animals harvested or caught for direct 
human consum ption. 
Article 223 
Animal health certificates and delegated acts 
1. Operato rs shall only move the following products of animal origin from aquatic animals other than live aquatic 
animals where those products are accompan ied by an animal health certificate issued by the compet ent author ity of the 
Member State of origin in accordance with paragraph 3: 
(a)  products of animal origin from aquatic animals that: 
(i)  are allowed to leave a restr icted zone subject to emergency measures as provided for in rules adop ted pursuant 
to Article 259; and 
(ii)  originat e from aquatic animals of species subject to those emergency measures; 
(b)  products of animal origin from aquatic animals that: 
(i)  are allowed to leave a restr icted zone subject to disease control measures in accordance with point (c) of 
Article 32(1), point (c) of Article 55(1), Article 56, point (a) of Article 61(1), Articles 62(1) and 63(1), point (c) 
of Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1) and Article 79 and the rules adop ted 
pursuant to Article 55(2), Articles 63 and 67 and Articles 71(3), 74(4) and 83(2); and 31.3.2016 L 84/140 Official Jour nal of the European Union EN     (ii)  originat e from aquatic animals of species subject to those disease control measures. 
2. By way of derog ation from paragraph 1, such a certificate shall not be required for movements of products of 
animal origin from wild aquatic animals, provided that: 
(a)  alternati ve risk-mitig ation measures author ised by the compet ent author ity are in place to ensure that those 
movements do not pose a risk of the spread of liste d diseases; 
(b)  consignments of such products are traceable. 
3. Operato rs shall take all necessar y measures to ensure that the animal health certificate refer red to in paragraph 1 
accompan ies the products of animal origin from their place of origin to their place of destination. 
4. The compet ent author ity shall, upon request by the operat or concer ned, issue an animal health certificate for 
movements of products of animal origin other than live aquatic animals as refer red to in paragraph 1, provided that the 
relevant requirements referred to in this Article have been compl ied with. 
5. Article 212 and Articles 214 to 217 and the rules adopt ed pursuant to Article 213 and Article 216(4) shall apply 
to the animal health certification of movements of products of animal origin other than live aquatic animals as refer red 
to in paragraph 1 of this Article. 
6. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
requirements and detailed rules on the animal health certificate to accompan y products of animal origin other than live 
aquatic animals, as referred to in paragraph 1 of this Article, taking into account: 
(a)  the types of products of animal origin concer ned; 
(b)  the risk-mitigation measures applied to the products concer ned which reduce the risks of the spread of diseases; 
(c)  the intended use of those products; 
(d)  the place of destination of those products. 
Article 224 
Content of animal health certificates and delegated and implementing acts 
1. The animal health certificate for products of animal origin from aquatic animals, other than live aquatic animals, 
shall contain at least the following information: 
(a)  the establishment or place of origin and the establishment or place of destination; 
(b)  a descr iption of the products of animal origin concer ned; 
(c)  the quantity (numbers, volume or weight) of the products of animal origin; 
(d)  the identification of the products of animal origin, when required by point (h) of Article 65(1) or by any rules 
adopt ed pursuant to Article 67; 
(e)  the information needed to demonstrate that the products concer ned fulfil the movement restr iction requirements 
provided for in Article 222(2) and in any rules adop ted pursuant to Article 222(3). 
2. The animal health certificate referred to in paragraph 1 may include other information required under other Union 
legislation. 
3. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning amending and supple ­
menting the information to be contained in the animal health certificate as provided for in paragraph 1 of this Article. 31.3.2016 L 84/141 Official Jour nal of the European Union EN     4. The Commission may, by means of implementing acts, lay down rules concer ning model forms of animal health 
certificates as provided for in paragraph 1 of this Article. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 225 
Notif ication of movements of products of animal origin to other Member States 
1. Operato rs shall: 
(a)  inform the compet ent author ity in the Member State of origin in advance of intended movements of products of 
animal origin from aquatic animals, other than live aquatic animals, when the consignments in question are required 
to be accompanied by an animal health certificate in accordance with Article 223(1); 
(b)  provide all necessar y information to enable the compet ent author ity of the Member State of origin to notify the 
movement in question to the Member State of destination in accordance with paragraph 2 of this Article. 
2. The compet ent author ity of the Member State of origin shall notify the compet ent author ity of the Member State 
of destination of movements of products of animal origin from aquatic animals, other than live aquatic animals, in 
accordance with Article 220(1). 
3. Articles 219 and 220 and any rules adopt ed pursuant to Article 221 shall be applicable to the notificati on of 
products of animal origin from aquatic animals, other than live aquatic animals. 
CHAPTER 4 
National measur es 
Article 226 
National measures designed to limit the impact of diseases other than listed disease 
1. Where a disease other than a listed disease as refer red to in point (d) of Article 9(1) constitutes a signif icant risk 
for the health of aquatic animals in a Member State, the Member State concer ned may take national measures to prevent 
the introduction, or to control the spread, of that disease. 
Member State s shall ensure that those national measures do not exceed the limits of what is appropr iate and necessar y 
in order to prevent the introduction, or to control the spread, of the disease in question within the Member State 
concer ned. 
2. Member State s shall notify the Commission in advance of any proposed national measures as referred to in 
paragraph 1 that may affect movements of aquatic animals and products of animal origin from aquatic animals between 
Member States. 
3. The Commission shall appro ve and, if necessar y, amend the national measures refer red to in paragraph 2 of this 
Article by means of implementing acts. Those implemen ting acts shall be adopt ed in accordance with the examination 
procedure refer red to in Article 266(2). 
4. The appro val referred to in paragraph 3 shall only be granted where the establishment of movement restr ictions 
between Member States is necessar y in order to prevent the introduction, or to control the spread, of the disease 
referred to in paragraph 1, taking into account the overall impact on the Union of the disease in question and of the 
measures taken. 31.3.2016 L 84/142 Official Jour nal of the European Union EN     TITLE III 
ANIMALS OF SPECIES OTHER THAN THOSE DEFINED AS TERRESTRIAL AND AQUATIC ANIMALS, AND 
GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN FROM SUCH OTHER ANIMALS 
Article 227 
Animal health requirements concer ning other animals, and germinal products and products of 
animal origin of such other animals 
Where other animals are of a liste d species for a listed disease as referred to in point (d) of Article 9(1), and those other 
animals or their germinal products or products of animal origin represent a risk to public or animal health in the 
Union, one or more of the following requirements shall apply: 
(a)  the requirements concer ning registration, appro val, record-ke eping and register s for establishments and transpor ters 
provided for in Chapt er 1 of Title I and Chapt er 1 of Title II (Articles 84 to 101 and Articles 172 to 175); 
(b)  the requirements concer ning traceability provided for in Articles 108 to 111 and Article 117 for other animals and 
Article 122 for germinal products; 
(c)  movement requirements: 
(i)  as regards other animals mainly living in a terrestrial environment or that are normally affected by diseases of 
terrestr ial animals, taking into account the criteria provided for in points (d) and (e) of Article 228(3), the 
requirements provided for in Section 1 (Articles 124 and 125) and Section 6 of Chapt er 3 of Title I of Part IV 
(Articles 137 to 142) and Chapt er 4 of Title I of Part IV (Articles 155 and 156); 
(ii)  as rega rds 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 points (d) and (e) of Article 228(3), the 
requirements provided for in Sections 1 to 4 of Chapt er 2 of Title II of Part IV (Articles 191 to 207); 
(iii)  as regards germinal products, the general requirements for movements provided for in Articles 157 and 158 
and the special requirements for movements to other Member States provided for in Articles 164 and 165; 
(iv)  as regar ds products of animal origin, the general animal health oblig ations incumbent on operat ors in respect of 
the production, processing and distr ibution within the Union of products of animal origin provided for in 
Articles 166 and 222; 
(d)  the animal health certification oblig ation incumbent on operat ors and compet ent author ities and the self–declaration 
incumbent on operat ors: 
(i)  as regards other animals, pursuant to the rules provided for in Articles 143 to 151 or Articles 208 to 218; 
(ii)  as regards germinal products, pursuant to the rules provided for in Articles 161 and 162; 
(iii)  as regar ds products of animal origin, pursuant to the rules provided for in Articles 165 and 168 or Articles 223 
and 224; 
(e)  the oblig ation to notify movements incumbent on operat ors and compet ent author ities, taking into account the 
requirements provided for in Articles 152, 153, 154, 163 and 169 and in Articles 219 to 221 and 225. 
Article 228 
Delegation of powers and implementing acts concer ning animal health requirements for other 
animals, and germinal products and products of animal origin of other animals 
1. The Commission shall be empowered to adop t delegat ed acts in accordance with Article 264 concer ning any 
specific requirements for other animals, and their germinal products or products of animal origin, which are necessar y 
in order to mitigat e the risk of the listed diseases refer red to in point (d) of Article 9(1), as provided for in Article 227. 31.3.2016 L 84/143 Official Jour nal of the European Union EN     2. The Commission may adopt implementing acts concer ning detailed rules for the implementation of the disease 
control and prevention measures provided for in paragraph 1. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
3. When adopt ing the delegat ed acts and implementing acts provided for in paragraphs 1 and 2, the Commission 
shall base those acts on the following criteria: 
(a)  the species or catego ries of other animals liste d in accordance with Article 8(2) as listed species for one or more 
liste d diseases, for whic h certain disease prevention and control measures provided for in this Regulation apply ; 
(b)  the prof ile of the listed disease in question, whic h concer ns species and categor ies of other animals refer red to in 
point (a); 
(c)  the feasibility , availability and effectiveness of disease prevention and control measures for the listed species 
concer ned by those measures; 
(d)  the prevailing terrestrial or aquatic living envi ronment of those other animals; 
(e)  the types of diseases that are affecting such other animals, which can be either diseases normally affecting terrestrial 
or aquatic animals, regar dless of the prevailing living environment refer red to in point (d). 
PART V 
ENTR Y INTO THE UNION AND EXPORT 
CHAPTER 1 
Entr y into the Union of animals, germinal products and products of animal origin from third countr ies 
and territories 
Section 1 
Requirements for the entr y into the Union 
Article 229 
Requirements for entr y into the Union of animals, germinal products and products of animal 
origin 
1. Member States shall permit the entr y into the Union of consignments of animals, germinal products and products 
of animal origin from third countr ies or territories only if those consignments fulfil the following requirements, unless 
such animals, germinal products or products of animal origin are covered by a derog ation grant ed pursuant to 
Article 239(2): 
(a)  without prejudice to Article 230(2), they come from a third countr y or territory listed in accordance with 
Article 230(1) for the particular species and cate gory of animals, or germinal products or products of animal origin 
concer ned, or from a zone or compar tment thereof; 
(b)  they come from establishments which are appro ved and listed, where such appro val and listing is required by 
Article 233; 
(c)  they fulfil the animal health requirements for entr y into the Union laid down in Article 234(1) and in any delegat ed 
acts adop ted pursuant to Article 234(2), where such requirements are laid down for the animal, germinal product or 
product of animal origin concer ned; 
(d)  they are accompan ied by an animal health certificate and by declarations and other documents where required by 
Article 237(1) or by rules adopt ed pursuant to Article 237(4); 31.3.2016 L 84/144 Official Jour nal of the European Union EN     2. The operat ors responsible for the consignment in question shall present consignments of animals, germinal 
products and products of animal origin from third countr ies or territories for the purposes of official control as 
provided for in Article 3 of Directive 91/496/EEC and Article 3 of Directive 97/78/EC. 
Section 2 
List ing of third countr ies and ter ritories 
Article 230 
Lists of third countr ies and territor ies from which the entr y into the Union of animals, germinal 
products and products of animal origin is permitted, and implementing and delegated acts 
1. The Commission may, by means of imple menting acts, draw up lists of third countr ies and territories from which 
the entr y into the Union of specif ic species and catego ries of animals, germinal products and products of animal origin 
is to be permitted, based on the following criteria: 
(a)  the animal health legislation of the third countr y or territory concer ned and the rules on the entr y into that third 
countr y or territory of animals, germinal products and products of animal origin from other third countr ies and 
territories; 
(b)  the assurances provided by the compet ent author ity of the third countr y or territory concer ned as regards the 
effic ient implementation and control of the animal health legislation referred to in point (a); 
(c)  the organisation, structure, resources and legal powers of the compet ent author ity in the third countr y or territory 
concer ned; 
(d)  the animal health certification procedures in the third countr y or territory concer ned; 
(e)  the animal health status of the third countr y or territory concer ned, or of zones and compar tments thereof, with 
regar d to: 
(i)  listed diseases and emerging diseases; 
(ii)  any aspects of animal and public health or the envi ronmental situation in the third countr y or territory 
concer ned, or in a zone or compar tment thereof, whic h may pose a risk to animal or public health or the 
envi ronmental status of the Union; 
(f)  the guarant ees which the compe tent author ity of the third countr y or territory concer ned can provide regarding 
compl iance or equivalence with the relevant animal health requirements applicable in the Union; 
(g)  the regular ity and speed with which the third countr y or territory concer ned supplies information concer ning 
infectious or contagious animal diseases in its territory to the World Org anisation for Animal Health (OIE), in 
particular information concer ning the diseases listed in the OIE Codes; 
(h)  the results of controls carried out by the Commission in the third countr y or territory concer ned; 
(i)  any exper ience gathered from previous entr ies of animals, germinal products and products of animal origin from the 
third countr y or territory concer ned and the results of official controls carried out at the point of entr y into the 
Union on such animals, germinal products and products of animal origin. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
2. Pending the adoptio n of the lists provided for in paragraph 1, and provided that such lists have not been drawn up 
pursuant to the Union legislation referred to in Article 270(2), Member States shall determine from which third 
countr ies and territori es specific species and catego ries of animals, germinal products or products of animal origin may 
enter the Union. 
For the purposes of the first subparagraph of this paragraph, Member States shall take into account the criteria for 
inclusion in the lists of third countr ies and territori es provided for in points (a) to (i) of paragraph 1 of this Article. 31.3.2016 L 84/145 Official Jour nal of the European Union EN     3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
derogat ions from paragraph 2 of this Article, limiting the possibility for Member States to decide from which third 
countr ies and territories a specifi c species and catego ry of animal, germinal product or product of animal origin may 
enter the Union, where necessar y due to the risk posed by that specif ic species and categor y of animal, germinal product 
or product of animal origin. 
Article 231 
Information to be included in the lists of third countr ies and territories 
The Commission shall specify the following information for each third countr y or territory in the lists provided for in 
Article 230(1): 
(a)  the species and categor ies of animals, germinal products or products of animal origin that may enter the Union 
from that third countr y or territory; 
(b)  whether the animals, germinal products or products of animal origin specif ied in accordance with point (a) may 
enter the Union from the whole territory of that third countr y or territory or only from one or more zones or 
compar tments thereof; 
(c)  specifi c conditions and animal health guarant ees concer ning listed diseases. 
Article 232 
Suspension and withdraw al from the lists of third countr ies and territori es and implementing acts 
1. The Commission shall, by means of implementing acts, withdra w a countr y or territory from the lists provided for 
in Article 230(1), or suspend the entr y into the Union of animals, germinal products or products of animal origin from 
a third countr y or territory, or from a zone or compar tment thereof, for any of the following reasons: 
(a)  the third countr y or territory concer ned, or one or more zones or compar tments thereof, no long er compl ies with 
the criteria laid down in Article 230(1), where relevant for the entr y into the Union of a particular species and 
catego ry of animal, germinal product or product of animal origin; 
(b)  the animal health situation in the third countr y or territory concer ned, or in a zone or compar tment thereof, is such 
that a suspension or withdrawa l from the lists is necessar y in order to protect the animal health status of the Union; 
(c)  the Commission has request ed the third countr y or territory concer ned to supply up-to –date information on the 
animal health situation and other matt ers refer red to in Article 230(1), and that third countr y or territory has not 
provided such information; 
(d)  the third countr y or territory concer ned has refused to agree to controls being carried out by the Commission on 
behalf of the Union in its territory . 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
2. On duly justif ied imperative grounds of urgency relating to a serious risk of the introduction into the Union of a 
listed disease as referred to in point (d) of Article 9(1), the Commission shall adopt immediately applicable 
implementing acts in accordance with the procedure refer red to in Article 266(3). 
3. The Commission may, by means of implementing acts, reinstate in the lists provided for in Article 230(1) a third 
countr y or territory, or a zone or compar tment thereof, that has been withdrawn from those lists, or may re–author ise 
the entr y into the Union of animals, germinal products or products of animal origin from a third countr y or territory, 
or from a zone or compar tment thereof, from whic h entr y into the Union has been suspended, for one of the following 
reasons: 
(a)  for the reasons refer red to in point (a) or (c) of paragraph 1 of this Article, provided that the third countr y or 
territory concer ned demonstrate s that it compl ies with the listing criteria provided for in Article 230(1); 31.3.2016 L 84/146 Official Jour nal of the European Union EN     (b)  for the reason refer red to in point (b) of paragraph 1 of this Article, provided that the third countr y or territory 
concer ned provides appropr iate guarant ees that the animal health situation that gave rise to the suspension or 
withdrawa l has been resolved or no longer represents a threat to animal or public health within the Union; 
(c)  for the reason refer red to in point (d) of paragraph 1 of this Article, provided that: 
(i)  the third countr y or territory concer ned has agreed to controls being carried out by the Commission on behalf 
of the Union in its territory; and 
(ii)  the results of those controls by the Commission show that the third countr y or territory concer ned, and the 
zones or compar tments thereof, comply with the listing criteria provided for in Article 230(1). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Section 3 
Appro val and listing of establishments in third countr ies and ter ritories 
Article 233 
Appro val and listing of establishments 
1. Member States shall only permit the entr y into the Union of terrestr ial animals and germinal products thereof 
originating from an establishment of a type for whic h appro val is required in the Union in accordance with 
Article 94(2) and the rules adopt ed pursuant to Article 94(3) and Article 95, if the establishment in question in the 
third countr y or territory concer ned: 
(a)  compl ies with animal health requirements in that third countr y or territory whic h are equivalent to the rules for 
establishments of that type applicable in the Union; 
(b)  is appro ved and listed by the compet ent author ity of the third countr y or territory of dispatch, unless alternati ve 
risk-mitigation measures in place in that third countr y or territory provide equivalent guarant ees for animal health 
within the Union. 
2. The Commission shall collect the lists of appro ved establishments referred to in point (b) of paragraph 1 received 
from the compe tent author ities of the third countr ies or territori es concer ned. 
3. The Commission shall provide to the Member States any new or updat ed lists of appro ved establishments received 
from the third countr ies or territories concer ned, and shall mak e them publicly available. 
4. The Commission shall, by means of implementing acts, adopt any rules necessar y in order to ensure unif orm 
application of point (b) of paragraph 1. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Section 4 
Entr y into the Union of species and categor ies of animals, ger minal products and 
products of animal origin 
Article 234 
Animal health requirements for the entr y into the Union of species and categor ies of animals, 
germinal products and products of animal origin 
1. The animal health requirements for the entr y into the Union of species and catego ries of animals, germinal 
products and products of animal origin from third countr ies or territories shall: 
(a)  be as stringent as the animal health requirements laid down in this Regulation and in the rules adopt ed pursuant 
thereto applicable to movements of the species and categor ies of animals, germinal products or products of animal 
origin in question within the Union; or 31.3.2016 L 84/147 Official Jour nal of the European Union EN     (b)  offer equivalent guarantees to the animal health requirements applicable to the species and categor ies of animals, 
germinal products or products of animal origin provided for in Part IV (Articles 84 to 228) of this Regulation. 
2. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning the animal health 
requirements for: 
(a)  the entr y into the Union of species and cate gories of animals, germinal products and products of animal origin from 
third countr ies or territori es; 
(b)  the movement within the Union and handling of those animals, germinal products and products of animal origin 
after their entr y into the Union, where this is necessar y in order to mitig ate the risk involved. 
3. Pending the adoption of delegat ed acts laying down animal health requirements as regards a particular species and 
catego ry of animal, germinal product or product of animal origin provided for in paragraph 1 of this Article, Members 
State may, following an evaluation of the risks involved, apply national rules, provided that those rules compl y with the 
requirements laid down in that paragraph and provided that they take into account the matt ers referred to in 
Articles 235 and 236. 
Article 235 
Matters to be taken into account in delegated acts provided for in Article 234 with regard to the 
entr y into the Union of animals 
The Commission shall take the following matters into account when laying down, in delegat ed acts as provided for in 
Article 234(2), animal health requirements for the entr y into the Union of particular species and catego ries of animals: 
(a)  the liste d diseases referred to in point (d) of Article 9(1) and emerging diseases; 
(b)  the health status of the Union concer ning the liste d diseases referred to in point (d) of Article 9(1) and emerging 
diseases; 
(c)  the liste d species with regard to those liste d diseases refer red to in point (d) of Article 9(1) and emerging diseases; 
(d)  the age and sex of the animals concer ned; 
(e)  the origin of the animals concer ned; 
(f)  the type of establishment concer ned 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 concer ned; 
(i)  any risk-mitigation measures in place in the third countr ies or territories of origin or transit, or after the arrival of 
the animals concer ned into the territory of the Union; 
(j)  animal health requirements applicable to movements of those animals within the Union; 
(k)  other epidemiological factors; 
(l)  internatio nal animal health trade standards, relevant to the species and cate gories of those animals. 
Article 236 
Matters to be taken into account in delegated acts as provided for in Article 234 with regard to 
the entr y into the Union of germinal products and products of animal origin 
The Commission shall take the following matters into account when laying down, in delegat ed acts as provided for in 
Article 234(2), the animal health requirements for the entr y into the Union of germinal products and products of 
animal origin: 
(a)  the liste d diseases referred to in point (d) of Article 9(1) and emerging diseases; 31.3.2016 L 84/148 Official Jour nal of the European Union EN     (b)  the health status of the animals from which the germinal products or products of animal origin originate and of the 
Union concer ning the listed diseases refer red to in point (d) of Article 9(1) and emerging diseases; 
(c)  the type and nature of particular germinal products or products of animal origin, treatments, processing methods 
and other risk-mitigation measures that have been applied at the places 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 concer ned; 
(g)  animal health requirements applicable to movements of the germinal products and products of animal origin 
concer ned within the Union; 
(h)  other epidemiological factors; 
(i)  internatio nal animal health trade standards, relevant for the germinal products and products of animal origin in 
question. 
Section 5 
Animal health cer tificates, declarations and other documents 
Article 237 
Animal health certificates, declarations and other documents for entr y into the Union 
1. Member States shall only permit the entr y into the Union of consignments of animals, germinal products and 
products of animal origin if such consignments are accompan ied by one or both of the following: 
(a)  an animal health certificate issued by the compet ent author ity of the third countr y or territory of origin, unless a 
derogation is provided for in point (a) of paragraph 4; 
(b)  declarations or other documents, where required by the rules adop ted pursuant to point (b) of paragraph 4. 
2. Member States shall not permit the entr y into the Union of consignments of animals, germinal products and 
products of animal origin unless the animal health certificate refer red to in point (a) of paragraph 1 has been verified 
and signed by an official veterinar ian in a third countr y or territory in compliance with certification requirements 
equivalent to those laid down in Article 149(3) or 216(3) and any rules adopt ed pursuant to Article 149(4) or 216(4). 
3. Member States shall permit electronic animal health certificates that are produced, handled and transmitted by 
means of Traces to replace the accompan ying animal health certificates refer red to in paragraph 1, where such electronic 
animal health certificates: 
(a)  contain all the information that the animal health certificate referred to in point (a) of paragraph 1 of this Article is 
required to contain in accordance with Article 238(1) and any rules adopt ed pursuant to Article 238(3); 
(b)  ensure the traceability of the consignments of animals, germinal products and products of animal origin concer ned 
and link those consignments to the electronic animal health certificate. 
4. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  derogations from the animal health certificate requirements provided for in point (a) of paragraph 1 and 
paragraph 2 of this Article, for consignments of animals, germinal products and products of animal origin, and in 
specifi c rules for the animal health certificat ion of those consignments, where the consignments in question pose an 
insignif icant risk to animal health or public health within the Union, due to one or more of the following factors: 
(i)  the species and catego ries of animals, germinal products or products of animal origin concer ned; 31.3.2016 L 84/149 Official Jour nal of the European Union EN     (ii)  the methods of keeping and types of production of the animals, germinal products and products of animal 
origin concer ned; 
(iii)  their intended use; 
(iv)  alternative risk-mitig ation measures which are in place in the third countr ies or territori es of origin or transit, or 
after their arrival into the territory of the Union, affording equivalent prote ction of animal health and public 
health within the Union as provided for in this Regulation; 
(v)  the provision by the third countr y or territory concer ned of guarant ees of compl iance with the requirements for 
entr y into the Union, demonstrated by means other than an animal health certificate; 
(b)  rules requir ing consignments of animals, germinal products and products of animal origin entering into the Union 
to be accompan ied by declarations or other documents needed to demonstrate that the animals, germinal products 
and products of animal origin in question meet the animal health requirements for entr y into the Union laid down 
in rules adopt ed pursuant to Article 234(2). 
Article 238 
Content of animal health certificates 
1. The animal health certificate refer red to in point (a) of Article 237(1) 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 concer ned; 
(b)  a descr iption of the animals, germinal products or products of animal origin concer ned; 
(c)  the number or volume of the animals, germinal products or products of animal origin concer ned; 
(d)  where applicable, the identif ication and registration of the animals, germinal products or products of animal origin 
concer ned; 
(e)  the information needed to demonstrate that the animals, germinal products and products of animal origin 
concer ned fulfil the animal health requirements for entr y into the Union provided for in Article 229 and 
Article 234(1) and in the rules adopt ed pursuant to Article 234(2) and Article 239. 
2. The animal health certificate referred to in point (a) of Article 237(1) may include other information required 
under other Union legislation. 
3. The Commission may, by means of imp lementing acts, lay down rules concer ning: 
(a)  information to be contained in the animal health certificate referred to in point (a) of Article 237(1) in addition to 
that refer red to in paragraph 1 of this Article; 
(b)  information to be contained in declarations or other documents as refer red to in point (b) of Article 237(1); 
(c)  model forms for the animal health certificates, declarations and other documents referred to in Article 237(1). 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 31.3.2016 L 84/150 Official Jour nal of the European Union EN     4. Pending the establishment of rules in implementing acts adopt ed pursuant to paragraph 3, as regards a particular 
species and catego ry of animal, germinal product or product of animal origin, Member States may, following an 
evaluation of the risks involved, apply national rules, provided those national rules compl y with the conditions laid 
down in paragraph 1. 
Section 6 
Derogations and additional requirements in respect of cer tain categor ies of 
animals, ger minal products and products of animal origin 
Article 239 
Derogations and additional requirements in respect of certain categor ies of animals, germinal 
products and products of animal origin 
1. For certain specifi c types of entr y of animals, germinal products and products of animal origin, the application of 
the rules set out in Article 229(1) and Articles 233 and 237 may not be adequate, and special rules may need to be 
adopt ed by the Commission through delega ted acts whic h take into account the particular risks, the final destination, 
the type of final use and other circumstances. 
2. The Commission shall adopt delegat ed acts in accordance with Article 264 concer ning the special rules refer red to 
in paragraph 1 of this Article regarding derogat ions from the requirements provided for in Article 229(1) and 
Articles 233 and 237 and imposing additional requirements for the entr y into the Union of the following: 
(a)  animals: 
(i)  intended for circuses, events, exhibitions, displa y, shows and conf ined establishments; 
(ii)  intended to be used for scientifi c or diagnostic purposes; 
(iii)  for which the Union is not the final destination; 
(iv)  whic h originate in the Union and whic h are moved to a third countr y or territory, and are then moved back to 
the Union from that third countr y or territory ; 
(v)  whic h originat e in the Union and whic h are transpor ted through a third countr y or territory en route to 
another part of the Union; 
(vi)  whic h are intende d for grazing purposes on a temporar y basis, in the vicinity of the Union's borders; 
(vii)  whic h pose an insignif icant risk to the animal health status within the Union; 
(b)  products of animal origin: 
(i)  intended for personal use; 
(ii)  for consum ption by the crew and passengers on means of transpor t arriving from third countr ies or territories; 
(c)  germinal products and products of animal origin: 
(i)  intende d to be used as trade samples; 
(ii)  intende d to be used as researc h and diagnostic sam ples; 
(iii)  for which the Union is not the final destination; 
(iv)  whic h originate in the Union and are moved to a third countr y or territory , and are then moved back to the 
Union from that third countr y or territory ; 31.3.2016 L 84/151 Official Jour nal of the European Union EN     (v)  whic h originate in the Union and are transpor ted through a third countr y or territory en route to another part 
of the Union; 
(vi)  whic h pose an insignif icant risk to the animal health status within the Union. 
Those delegat ed acts shall take into account the matte rs referred to in Article 235 and 236. 
3. The Commission may, by means of imp lementing acts, lay down rules: 
(a)  concer ning model forms for the animal health certificates, declarations and other documents for the categor ies of 
animals, germinal products and products of animal origin refer red to in paragraph 2 of this Article; 
(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 other relevant Union rules. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 2 
Entr y into the Union of certain goods other than animals, germinal products and produ cts of animal 
origin from third countr ies and territories 
Article 240 
Disease agents and delegated acts 
1. Operato rs, veterinar ians, aquatic animal health profess ionals and animal profe ssionals bringing disease agents into 
the Union shall: 
(a)  take appropr iate measures to ensure that the entr y of those disease agents 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 point (d) of Article 9(1) 
and emerging diseases; 
(b)  take appropr iate disease control and preventive measures to ensure that the entr y of those disease agents into the 
Union does not present a risk of bioter rorism. 
This paragraph shall also apply to any other natural or legal person bringing such agents into the Union intentionally . 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 laying down 
requirements for the entr y into the Union of disease agents concer ning: 
(a)  the packag ing of disease agents; 
(b)  other risk-mitig ation measures required in order to prevent the release and spread of disease agents. 
Article 241 
Plant mater ial and delegated and implementing acts 
1. The Member States shall take measures to restr ict the entr y into the Union of consignments of plant mater ial in 
the event of an unfa vour able disease situation in third countr ies or territories concer ning listed diseases as refer red to in 
point (d) of Article 9(1) or emerging diseases, where this is required by the rules adopt ed in accordance with 
paragraph 3 of this Article. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
measures refer red to in paragraph 1 of this Article, setting out: 
(a)  specifi c animal health requirements for the entr y into the Union of plant mater ial whic h acts as a path of 
transmission of liste d or emerging diseases; 31.3.2016 L 84/152 Official Jour nal of the European Union EN     (b)  requirements in relation to: 
(i)  animal health certification, taking into account the rules provided for in point (a) of Article 237(1) and 
Article 237(2) and (3); or 
(ii)  declarations or other documents, taking into account the rules provided for in point (b) of Article 237(1). 
3. The Commission shall lay down the animal health requirements provided for in paragraph 2 on the basis of the 
following criteria: 
(a)  whether a listed or emerging disease that can be transmitted by means of plant mat erial represents a serious risk to 
animal or to human health in the Union; 
(b)  the likelihood that animals of liste d species for a particular listed disease or emerging disease will come into direct 
or indirect contact with the plant mater ial refer red to in paragraph 2; 
(c)  the availability and effectiveness of alternative risk-mitigation measures in relation to that plant mate rial, whic h may 
eliminate or minimise the risk of transmission refer red to in point (a). 
4. The Commission may, by means of implementing acts, lay down rules indicating, for the plant mat erial refer red to 
in paragraph 2 of this Article, the codes from the Combined Nomenclature, where such indication is not provided for 
by other relevant Union rules. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
Article 242 
Means of transpor t, equipment, packa ging mater ials, transpor t water and feed and fodder and 
delegated and implementing acts 
1. Operato rs bringing animals and products into the Union shall take the appropr iate and necessar y disease 
prevention measures during transpor t, as provided for in Articles 125(1) and 192(1). 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  specifi c animal health requirements for the entr y into the Union of: 
(i)  means of transpor t for animals and products; 
(ii)  equipment, packag ing mater ial or transpor t water for animals and products, or feed and fodder whic h may 
transmit animal diseases; 
(b)  requirements in relation to: 
(i)  animal health certification, taking into account the rules provided for in point (a) of Article 237(1) and 
Article 237(2) and (3); or 
(ii)  declarations or other documents, taking into account the rules provided for in point (b) of Article 237(1). 
3. The Commission shall lay down the animal health requirements provided for in paragraph 2 of this Article in the 
event of a unfa vour able disease situation concer ning one or more listed diseases as refer red to in point (d) of 
Article 9(1), or emerging diseases, which present a serious risk to animal and human health in the Union, in: 
(a)  a neighbour ing third countr y or territory ; 
(b)  the third countr y or territory of origin; 
(c)  a third countr y or territory of transit. 31.3.2016 L 84/153 Official Jour nal of the European Union EN     4. The Commission may, by means of imple menting acts, lay down rules indicating, for the goods refer red to in 
point (a) of paragraph 2 of this Article, the codes from the Combined Nomenclature, where such indication is not 
provided for by other relevant Union rules. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
CHAPTER 3 
Expor t 
Article 243 
Expor t from the Union 
1. Member States shall take the appropr iate measures to ensure that the expor t and re–expor t from the Union to a 
third countr y 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 (Articles 84 to 228), while taking into account the animal 
health status within the third countr y or territory of destination, or the relevant zone or compar tment thereof, with 
regar d to the listed diseases refer red to in point (d) of Article 9(1) and emerging diseases. 
2. By way of derog ation from paragraph 1, if so requeste d by the compet ent author ity of a third countr y or territory 
importing the animals and products in question, or if established by the legal and administrative procedures in force in 
that third countr y or territory, expor t and re–expor t from the Union may take place in accordance with the provisions 
in force in that third countr y or territory , provided that such expor ts or re-expor ts do not jeopardise public or animal 
health. 
3. Where the provisions of a bilat eral agreement concluded between the Union and a third countr y or territory are 
applicable, animals and products expor ted from the Union to that third countr y or territory shall compl y with those 
provisions. 
PART VΙ 
NON–COMMER CIAL MO VEMENTS OF PET ANIMALS INTO A MEMBER STATE FROM 
ANOTHER MEMBER STATE OR FROM A THIRD COUNTR Y OR TERRITOR Y 
CHAPTER 1 
Gener al provisions 
Article 244 
Scope of Part VI 
1. This Part shall apply to the non–commercial movement of pet animals into a Member State from another Member 
State or from a third countr y or territory. 
2. It shall apply without prejudice to: 
(a)  Council Regulation (EC) No 338/97 (1); 
(b)  any national measures adopt ed, published and made available to the public by Member States to restr ict the 
movement of certain species or breeds of pet animals on the basis of considerations other than those relating to 
animal health. 
Article 245 
General provisions 
1. Non–commercial movements of pet animals that fulfil the animal health requirements laid down in this Part shall 
not be prohibited, restr icted or impeded on animal health grounds other than those resulting from the application of 
this Part. 31.3.2016 L 84/154 Official Jour nal of the European Union EN     
(1)Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein 
(OJ L 61, 3.3.1997, p. 1). 2. Where the non–commercial movement of a pet animal is carried out by an author ised person, it may only take 
place within five days from the movement of the pet owner . 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning 
requirements supplementing the rules laid down in paragraph 2 of this Article in relation to the following: 
(a)  documentation of the non–commercial movement of a pet animal carried out by an author ised person; 
(b)  granting of derog ations from the period refer red to in paragraph 2 of this Article. 
4. The Commission may, by means of implementing acts, lay down requirements for the layout, languages and 
validity of the declaration author ising an author ised person in writing to carry out the non–commercial movement of a 
pet animal on behalf of the pet owner . Those imp lementing acts shall be adopt ed in accordance with the examination 
procedure refer red to in Article 266(2). 
Article 246 
Maximum number of pet animals 
1. The number of pet animals of the species liste d in Part A of Annex I which may be moved during a sing le non– 
commercial movement shall not exceed five. 
2. By way of derog ation from paragraph 1, the number of pet animals of the species listed in part A of Annex I may 
exceed five if the following conditions are fulfilled: 
(a)  the non–commercial movement in question is for the purpose of participating in a competition, exhibition or 
spor ting event or training for such an event ; 
(b)  the pet owner or the author ised person concer ned submits written evidence that the pet animals are registere d either 
to attend an event as referred to in point (a), or with an association orga nising such events; 
(c)  the pet animals are more than six months old. 
3. In order to prevent commercial movements of pet animals of the species liste d in Part B of Annex I from being 
fraudulently disguised as non–commercial movements, the Commission shall be empo wered to adop t delegat ed acts in 
accordance with Article 264 concer ning rules setting the maximum number of pet animals of those species which may 
be moved during a sing le non–commercial movement. 
CHAPTER 2 
Conditions applicable to non–commer cial movements of pet animals into a Member State from another 
Member State 
Article 247 
Conditions applicable to non–commercial movements of pet animals of the species listed in Part A 
of Annex I 
Pet animals of the species liste d in Part A of Annex I shall not be moved into a Member State from another Member 
State unless: 
(a)  they are individually identified by a physical means of identif ication in accordance with the rules adopt ed pursuant 
to point (a) of Article 252(1); 
(b)  they fulfil the relevant prevention and risk-mitig ation measures adop ted pursuant to point (b) of Article 252(1) in 
relation to liste d diseases as refer red to in point (d) of Article 9(1); 
(c)  they are accompan ied by an identif ication document duly complet ed and issued in accordance with the rules 
adopt ed pursuant to point (d) of Article 254. 31.3.2016 L 84/155 Official Jour nal of the European Union EN     Article 248 
Conditions applicable to non–commercial movements of pet animals of the species listed in Part B 
of Annex I 
1. In so far as the Commission has adop ted a delegat ed act pursuant to point (b) of Article 252(1) with regar d to pet 
animals of one of the species listed in Part B of Annex I, non-commercial movements of pet animals of that species into 
a Member State from another Member State shall be subject to compl iance with the conditions laid down in 
paragraph 2 of this Article. 
2. Pet animals of the species referred to in paragraph 1 may be moved into a Member State from another Member 
State only if: 
(a)  they are identified or descr ibed, either individually or in groups, in accordance with the rules adopt ed pursuant to 
point (a) of Article 252(1); 
(b)  they comply with the relevant prevention and risk-mitig ation measures adopt ed pursuant to point (b) of 
Article 252(1) in relation to listed diseases as refer red to in point (d) of Article 9(1); 
(c)  they are accompan ied by an identif ication document duly complet ed and issued in accordance with the rules 
adopt ed pursuant to point (d) of Article 254; 
3. Pending the adop tion of the relevant delegat ed acts refer red to in paragraph 1, Member State s may apply national 
rules to non–commercial movements of pet animals of the species liste d in Part B of Annex I into their territory from 
another Member State, provided that such rules are: 
(a)  applied propor tionately to the risk to public or animal health associated with non–commercial movements of pet 
animals of those species; and 
(b)  not stricter than those applied to movements of animals of those species in accordance with Part IV. 
CHAPTER 3 
Conditions applicable to non–commer cial mov ements of pet animals into a Member State from a third 
countr y or territory 
Article 249 
Conditions applicable to non–commercial movements of pet animals of the species listed in Part A 
of Annex I 
1. Pet animals of the species listed in Part A of Annex I shall not be moved into a Member State from a third countr y 
or territory unless: 
(a)  they are individually identified by a physical means of identif ication in accordance with the rules adopt ed pursuant 
to point (a) of Article 252(1); 
(b)  they comply with the relevant prevention and risk-mitig ation measures adopt ed pursuant to point (b) of 
Article 252(1) in respect of listed diseases as referred to in point (d) of Article 9(1); 
(c)  they are accompan ied by an identif ication document duly complet ed and issued in accordance with the rules 
adopt ed pursuant to point (d) of Article 254. 
2. Pet animals of the species listed in Part A of Annex I may be moved into a Member State from a third countr y or 
territory other than those listed pursuant to Article 253(1)(d) only through a point of entr y listed for that purpose. Each 
Member State shall draw up a list of those points of entr y within its territory and shall make that list available to the 
public. 
3. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
conditions for granting derog ations from paragraph 2 of this Article. 31.3.2016 L 84/156 Official Jour nal of the European Union EN     Article 250 
Conditions applicable to non–commercial movements of pet animals of the species listed in Part B 
of Annex I 
1. In so far as the Commission has adop ted a delegat ed act pursuant to point (b) of Article 252(1) with regar d to pet 
animals of one of the species listed in Part B of Annex I, non–commercial movements of pet animals of that species into 
a Member State from a third countr y or territory shall be subject to compl iance with the conditions laid down in 
paragraph 2 of this Article. 
2. Pet animals of the species refer red to in paragraph 1 may be moved into a Member State from a third countr y or 
territory only if: 
(a)  they are identified or descr ibed, either individually or in groups, in accordance with the rules adopt ed pursuant to 
point (a) of Article 252(1); 
(b)  they comply with the relevant prevention and risk-mitig ation measures adopt ed pursuant to point (b) of 
Article 252(1) in relation to listed diseases as refer red to in point (d) of Article 9(1); 
(c)  they are accompan ied by an identif ication document duly complet ed and issued in accordance with the rules 
adopt ed pursuant to point (d) of Article 254; 
(d)  when coming from a third countr y or territory other than those listed pursuant to point (d) of Article 253(1), they 
enter through a point of entr y liste d for that purpose. Each Member State shall draw up a list of those points of 
entr y within its territory and shall make that list available to the public. 
3. Pending the adop tion of the relevant delegat ed acts refer red to in paragraph 1, Member State s may apply national 
rules to non–commercial movements of pet animals of the species listed in Part B of Annex I into their territory from a 
third countr y or territory , provided that such rules are: 
(a)  applied propor tionately to the risk to public or animal health associated with non–commercial movements of pet 
animals of those species; and 
(b)  not stricter than those applied to the entr y into the Union of animals of those species in accordance with Part V. 
Article 251 
Derogation from the conditions applicable to non–commercial movements of pet animals betw een 
certain countr ies and territories 
By way of derog ation from Articles 249 and 250, non–commercial movements of pet animals between the following 
countr ies and territories may continue under the conditions laid down by the national rules of those countr ies and 
territories: 
(a)  San Mar ino and Italy ; 
(b)  the Vatican and Italy ; 
(c)  Monaco and France; 
(d)  Andor ra and France; 
(e)  Andor ra and Spain; 
(f)  Nor way and Sweden; 
(g)  the Faeroe Islands and Denmark; 
(h)  Greenland and Denmark. 31.3.2016 L 84/157 Official Jour nal of the European Union EN     CHAPTER 4 
Identification and prevention and risk-mitig ation measur es 
Article 252 
Delegation of powers concer ning the identif ication of pet animals and prev ention and risk- 
mitigation measures 
1. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning: 
(a)  detailed species–specifi c requirements for: 
(i)  the means of identif ication of pet animals of the species listed in Annex I provided for in point (a) of 
Article 247, point (a) of Article 248(2), point (a) of Article 249(1) and point (a) of Article 250(2); 
(ii)  the application and use of those means of identification; 
(b)  detailed species–specific requirements for the prevention and risk-mitigation measures to ensure that pet animals do 
not pose a significant risk for the spread of liste d diseases as refer red to in point (d) of Article 9(1) due to 
movements of pet animals of the species listed in Annex I as provided for in point (b) of Article 247, point (b) of 
Article 248(2), point (b) of Article 249(1) and point (b) of Article 250(2). 
2. Where, in the case of emerging risks, imperative grounds of urgency so require, the procedure provided for in 
Article 265 shall apply to rules adopt ed pursuant to point (b) of paragraph 1 of this Article. 
3. The species–specific prevention and risk-mitigation measures author ised by a delegat ed act adopt ed pursuant to 
point (b) of paragraph 1 of this Article shall be based on adequate , reliable and validated scientifi c information and 
applied propor tionately to the risk to public or animal health associated with non–commercial movements of pet 
animals likely to be affect ed by liste d diseases as refer red to in point (d) of Article 9(1). 
4. The delegat ed acts provided for in point (b) of paragraph 1 may also comprise the following: 
(a)  rules for the cate gorisation of Member States or parts thereof according to their animal health status and their 
surveillance and repor ting system s with regard to certain diseases that are likely to be spread by movements of pet 
animals of the species listed in Annex I; 
(b)  the conditions that Member States are to fulfil in order to remain eligible for the application of the prevention and 
risk-mitigation measures refer red to in point (b) of paragraph 1; 
(c)  the conditions for applying and documenting the prevention and risk-mitigation measures refer red to in point (b) of 
paragraph 1; 
(d)  the criteria for granting and, where appropr iate, documenting derogations in certain specifi ed circumstances from 
the application of the prevention and risk-mitigation measures referred to in point (b) of paragraph 1; 
(e)  the criteria for granting and documenting derogat ions in certain specifi ed circumstances from the conditions refer red 
to in Articles 247 to 250. 
Article 253 
Implementing acts concer ning prev ention and risk-mitigation measures 
1. The Commission shall, by means of imple menting acts, as regar ds pet animals of the species listed in Part A of 
Annex I: 
(a)  lay down rules on the format, layout and languages of any documents required under points (c) and (d) of 
Article 252(4); 31.3.2016 L 84/158 Official Jour nal of the European Union EN     (b)  adopt a list of Member States that compl y with the conditions refer red to in point (d) of Article 252(4) and remo ve 
Member States from that list should any change occur in relation to those conditions; 
(c)  adopt a list of Member States that compl y with the rules for catego risation of Member States or parts thereof 
refer red to in point (a) of Article 252(4) and remo ve Member States from that list should any change occur in 
relation to those rules; 
(d)  adopt a list of third countr ies and territories that compl y with the conditions referred to in point (d) of 
Article 252(4) and remo ve third countr ies or territori es from that list should any change occur in relation to those 
conditions. 
2. The Commission may, by means of implementing acts, as regar ds pet animals of the species listed in Part B of 
Annex I, adopt a list of third countr ies and territories that comply with the conditions refer red to in point (d) of 
Article 252(4) and remo ve third countr ies or territori es from that list should any change occur in relation to those 
conditions. 
3. The implementing acts refer red to in paragraphs 1 and 2 of this Article shall be adop ted in accordance with the 
examination procedure refer red to in Article 266(2). 
4. On duly justif ied imperative grounds of urgency relating to serious risks, the Commission shall adopt immediately 
applicable implementing acts updating the lists refer red to in points (b) and (d) of paragraph 1 of this Article in 
accordance with the procedure refer red to in Article 266(3). 
CHAPTER 5 
Identification documents 
Article 254 
Delegation of powers concer ning identif ication documents 
The Commission shall be empo wered to adopt delega ted acts in accordance with Article 264 concer ning: 
(a)  entr ies for the inser tion of the information to be included in the identif ication documents refer red to in point (c) of 
Article 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2); 
(b)  the distr ibution of blank identif ication documents as referred to in point (c) of Article 247; 
(c)  the conditions for granting derogations in relation to the format of the identification documents provided for in 
point (c) of Article 247 and point (c) of Article 249(1); 
(d)  the issue, compl etion and, where applicable, endorsement of the identif ication documents provided for in point (c) 
of Articles 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2). 
Article 255 
Implementing acts concer ning identif ication documents 
1. The Commission shall adopt implementing acts laying down the model for identif ication documents as referred to 
in point (c) of Article 247 and point (c) of Article 249(1). That model shall contain the respective entr ies referred to in 
point (a) of Article 254, as well as requirements concer ning the languages, layout, validity or secur ity features of those 
identif ication documents. 
2. The Commission may, by means of imp lementing acts, adop t: 
(a)  the model for identification documents as referred to in point (c) of Article 248(2) and point (c) of Article 250(2), 
which are to contain the respective entr ies refer red to in point (a) of Article 254, as well as requirements concer ning 
the language s, layout, validity or secur ity features of those identif ication documents; 
(b)  the rules necessar y for transition to the model identif ication document refer red to in point (c) of Article 247. 31.3.2016 L 84/159 Official Jour nal of the European Union EN     3. The implementing acts refer red to in paragraphs 1 and 2 of this Article shall be adop ted in accordance with the 
examination procedure refer red to in Article 266(2). 
CHAPTER 6 
Information oblig ations 
Article 256 
Information obligations 
1. Member States shall provide the public with clear and easily accessible information concer ning the animal health 
requirements applicable to non–commercial movements of pet animals, including: 
(a)  conditions for the grant of certain derogations referred to in point (d) of Article 252(4); 
(b)  conditions for the grant of derogations refer red to in point (e) of Article 252(4); 
(c)  requirements for the application of the means of identif ication referred to in point (a)(ii) of Article 252(1); 
(d)  conditions applicable to non–commercial movements into Member States' territories of pet animals of the species 
refer red to in Part B of Annex I, which are laid down by their national rules as provided for in Articles 248(3) 
and 250(3); 
(e)  conditions applicable to non–commercial movements into Member States' territori es of pet animals from certain 
countr ies and territori es laid down by their national rules as refer red to in Article 251; 
(f)  any relevant information concer ning certain prevention and risk-mitigation measures as referred to in point (b) of 
Article 252(1). 
2. Member State s shall establish internet–based information pages providing the information refer red to in 
paragraph 1, and shall communicat e the internet address of those pages to the Commission. 
3. The Commission shall assist the Member States in making that information available to the public by providing on 
its internet page: 
(a)  link s to the intern et–based information pages of the Member State s; 
(b)  the information referred to in points (a) and (d) of paragraph 1, and the information made available to the public as 
refer red to in point (b) of Article 244(2) in additional languag es, as appropr iate. 
PART VIΙ 
EMER GENCY MEASURES 
Section 1 
Emergency measures concer ning mo vements of animals and products within the 
Union and means of transpor t and other mater ial that may hav e come into cont act 
with such animals and products 
Article 257 
Emergency measures to be taken by the competent author ity of the Member State in the territory 
of which an outbreak of a listed disease or emerging disease, or a hazard occur red 
1. In the event of an outbreak of a listed disease or emerging disease, or the occur rence of a hazard whic h is likely to 
constitute a serious risk to animal or public health, the compet ent author ity of the Member State where it occur red 
shall, depending on the gravity of the situation and the disease or hazard in question, immediately take one or more of 
the following emerge ncy measures to prevent the spread of the disease or hazard: 
(a)  for listed diseases: 
(i)  referred to in point (a) of Article 9(1), the disease control measures laid down in Chapt er 1 of Title II of Part III 
(Articles 53 to 71); 31.3.2016 L 84/160 Official Jour nal of the European Union EN     (ii)  referred to in point (b) of Article 9(1), the disease control measures laid down in Articles 72 to 75 and 77 to 81 
of Chapt er 2 of Title II of Part III; 
(iii)  referred to in point (c) of Article 9(1), the disease control measures laid down in Articles 76 to 78 and 
Articles 80 and 82 of Chapt er 2 of Title II of Part III; 
(b)  for emerging diseases and hazards: 
(i)  restr ictions on the movement of animals and products originating from the establishments, or, where relevant, 
the restr icted zones or compar tments, where the outbreak or the hazard occur red, and on means of transpor t 
and other mate rial 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 emerg ency disease control measures provided for in Chapt er 1 of Title II of Part III (Articles 53 to 71) that 
are appropr iate; 
(c)  any other emergency measure which it deems appropr iate in order to effectively and efficiently control and prevent 
the spread of the disease or hazard. 
2. The compet ent author ity refer red to in paragraph 1 shall inform the Commission and the other Member States: 
(a)  immediately of any outbreak or the occur rence of a hazard as refer red to in paragraph 1; 
(b)  without dela y of the emergency measures taken pursuant to paragraph 1. 
Article 258 
Emergency measures to be taken by a Member State other than the Member State where the 
outbreak or hazard occur red 
1. The compe tent author ity of a Member State other than the Member State where the outbreak or hazard refer red to 
in Article 257(1) occur red shall, depending on the gravity of the situation and the disease or hazard in question, take 
one or more of the emerge ncy measures referred to in Article 257(1) where it detects on its territory animals or 
products from the Member State refer red to in Article 257(1) or means of transpor t or any other mate rial that may 
have come into contact with such animals and products. 
2. The compet ent author ity refer red to in paragraph 1 of this Article may, where a serious risk exists pending the 
adoptio n of emerg ency measures by the Commission in accordance with Article 259, take the emerge ncy measures 
referred to in Article 257(1) on an interi m basis, depending on the gravity of the situation with regar d to animals or 
products originating from the establishments or other locations, or where relevant from the restr icted zones of the 
Member State, where the disease or hazard referred to in Article 257(1) occur red, or means of transpor t or other 
mate rial that may have come into contact with such animals. 
3. A Member State may take measures as refer red to in Article 257(1) in the event of an outbreak in a third countr y 
or territory border ing the Union of a disease referred to in point (a) of Article 9(1) or an emerging disease in such a 
third countr y or territory, in so far as those measures are necessar y in order to prevent the spread of the disease into the 
territory of the Union. 
4. The compet ent author ity referred to in paragraph 1 and the compet ent author ity of the Member State referred to 
in paragraph 3 shall inform the Commission and other Member States: 
(a)  immediately of the outbreak or occur rence of a hazard refer red to in paragraph 1; 
(b)  without dela y of the emergency measures taken pursuant to paragraphs 1 and 2. 31.3.2016 L 84/161 Official Jour nal of the European Union EN     Article 259 
Commission emergency measures 
1. In the event of an outbreak or the occur rence of a hazard as referred to in Article 257(1), and of emergency 
measures taken by the compet ent author ities of the Member State s in accordance with Article 257(1) and 
Article 258(1), (2) and (3), the Commission shall review the situation and the emergency measures taken, and shall 
adopt, by means of an implementing act, one or more of the emerg ency measures provided for in Article 257(1) 
concer ning the animals and products in question and means of transpor t and other mat erial that may have come into 
contact with those animals or products, in any of the following cases: 
(a)  where the Commission has not been informed of any measures taken pursuant to Article 257(1) and Article 258(1), 
(2) and (3); 
(b)  where the Commission considers the measures taken pursuant to Article 257(1) and Article 258(1), (2) and (3) to be 
inadequate ; 
(c)  where the Commission considers it necessar y to appro ve or replace the measures taken by the compet ent author ities 
of the Member States pursuant to Article 257(1) and Article 258(1), (2) and (3) in order to avoid unjustified 
disruptions in the movement of animals and products. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(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 immediat ely applicable implementing acts in accordance with Article 266(3). 
Section 2 
Emergency measures concer ning consignments of animals and products 
originating from third countr ies and ter ritories, and means of transpor t and other 
mater ial, that may hav e come into contact with such consignments 
Article 260 
Emergency measures to be taken by the competent author ity 
Where the compe tent author ity of a Member State becomes aware of animals or products originating from a third 
countr y or territory, or of means of transpor t or mate rials, which may have come into contact with such animals and 
products, that are likely to constitut e a serious risk in the Union due to possible infection or contamination by liste d 
diseases or emerging diseases or hazards, it shall: 
(a)  immediately take one or more of the following emerge ncy measures necessar y to mitig ate that risk, depending on 
the gravity of the situation: 
(i)  destr uction of the animals and products concer ned; 
(ii)  quarantine of animals and isolation of products; 
(iii)  surveillance and traceability measures; 
(iv)  any disease control measures refer red to in Chapt er 1 of Title II of Part III (Articles 53 to 71), where 
appropr iate; 
(v)  any other emerg ency measure whic h it deems appropr iate to prevent the spread of the disease or hazard into 
the Union; 31.3.2016 L 84/162 Official Jour nal of the European Union EN     (b)  immediately inform the Commission and the other Member States of the risks associated with the animals and 
products in question and of the origin of those animals and products by means of Traces, and without dela y of the 
emerge ncy measures taken pursuant to point (a). 
Article 261 
Commission emergency measures 
1. Where a listed disease, an emerging disease or a hazard that is likely to constitut e a serious risk occurs or spreads 
in a third countr y or territory, or if any other serious animal or public health reason so warrants, the Commission may, 
by means of an imp lementing act and acting on its own initiative or at the request of a Member State, adopt one or 
more of the following emerg ency measures, depending on the gravity of the situation: 
(a)  suspend the entr y into the Union of consignments of animals and products, and means of transpor t or other 
mater ial, 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 entr y into the Union of animals and products, and of means of transpor t and 
other mater ial that may have come into contact with such animals and products, which may spread that disease or 
hazard into the Union; 
(c)  take any other appropr iate emerge ncy disease control measures to prevent the spread of such disease or hazard into 
the Union. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
2. On duly justif ied imperativ e grounds of urgency relating to serious risks, the Commission shall, after consulting 
the Member State concer ned, adopt immediate ly applicable implementing acts in accordance with the procedure refer red 
to in Article 266(3). 
Article 262 
Emergency measures to be taken by Member States when the Commission does not act 
1. Where a Member State has request ed the Commission to take emerg ency measures in accordance with Article 261 
and the Commission has not done so, that Member State: 
(a)  may, pending the adop tion of emerge ncy measures by the Commission in accordance with paragraph 2 of this 
Article, take one or more of the emerg ency measures referred to in point (a) of Article 260 on an interim basis in 
respect of animals and products, and any means of transpor t and other mater ial that may have come into contact 
with such animals and products, originating from the third countr y or territory refer red to in Article 261(1), 
depending on the grav ity of the situation within its territory; 
(b)  shall inform the Commission and the compet ent author ities of the other Member States of such emerg ency 
measures without dela y, giving the reason for their adopt ion. 
2. The Commission shall review the situation and the emerge ncy measures take n by the Member State concer ned in 
accordance with paragraph 1 of this Article and shall, where necessar y, adopt by means of an implementing act one or 
more of the emerg ency measures provided for in Article 261. 
Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 266(2). 
3. On duly justif ied imperative grounds of urgency relating to serious risks, the Commission shall adopt immediately 
applicable implementing acts in accordance with the procedure refer red to in Article 266(3). 31.3.2016 L 84/163 Official Jour nal of the European Union EN     PART VIIΙ 
COMMON PROVISIONS 
TITLE I 
PROCEDURAL PROVISIONS 
Article 263 
Amendments to Annex III 
The Commission shall be empowered to adopt delegat ed acts in accordance with Article 264 concer ning amendments to 
Annex III, limite d excl usively to taking into account chang es in taxonom y. 
Article 264 
Exercise of the delegation 
1. The power to adop t delegat ed acts is confe rred on the Commission subject to the conditions laid down in this 
Article. 
2. It is of particular importance that the Commission carry out consultations with exper ts, including Member States' 
exper ts, before adopting those delegat ed acts. 
3. The power to adopt delegat ed acts refer red to in Articles 3(5), 5(2) 5(4), 14(3), 16(2), 18(3), 20(3), 29, 31(5), 
32(2), 37(5), 39, 41(3), 42(6), 47, 48(3), 53(2), 54(3), 55(2), 58(2), 63, 64(4), 67, 68(2), 68(3), 70(3), 72(2), 73(3), 
74(4), 76(5), 77(2), 87(3), 94(3), 97(2), 101(3), 106(1), 109(2), 118, 119, 122(1), 122(2), 125(2), 131(1), 132(2), 135, 
136(2), 137(2), 138(3), 139(4), 140, 144(1), 146(1), 147, 149(4), 151(3), 154(1), 156(1), 160(1), 160(2), 161(6), 
162(4), 163(5), 164(2), 165(3), 166(3), 167(5), 168(3), 169(5), 176(4), 181(2), 185(5), 189(1), 192(2), 197(3), 200(3), 
201(3), 202(3), 203(2), 204(3), 205(2), 211(1), 213(1), 214, 216(4), 218(3), 221(1), 222(3), 223(6), 224(3), 228(1), 
230(3), 234(2), 237(4), 239(2), 240(2), 241(2), 242(2), 245(3), 246(3), 249(3), 252(1), 254, 263, 271(2), 272(2), 
279(2), and 280(4) shall be conferred on the Commission for a period of five years from 20 Apr il 2016. 
The Commission shall draw up a repor t in respect of the delegat ion of power not later than nine months before the end 
of the five-y ear period. The delegation of power shall be tacitly exte nded for periods of an identical duration, unless the 
European Parliament or the Council opposes such exte nsion not later than three months before the end of each period. 
4. The delegation of power refer red to in paragraph 3 may be revok ed at any time by the European Parliament or by 
the Council. A decision to revok e shall put an end to the delegat ion of the power specif ied 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 delegat ed acts already in force. 
5. As soon as it adop ts a delegat ed act, the Commission shall notify it simultaneously to the European Parliament and 
to the Council. 
6. A deleg ated act adopt ed pursuant to the provisions liste d in paragraph 3 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 notifi cation 
of that act to the European Parliament and the Council or if, before the expir y of that period, the European Parliament 
and the Council have both informed the Commission that they will not object. That period shall be exte nded by two 
months at the initiative of the European Parliament or of the Council. 31.3.2016 L 84/164 Official Jour nal of the European Union EN     7. The Commission shall allow a period of at least six months to elapse between the adoptio n of the respective initial 
delegat ed acts referred to in Articles 3(5), 14(3), 16(2), 20(3), 122(2), 164(2) and 228(1) and the date on whic h they 
start to apply . 
Article 265 
Urgency procedure 
1. Deleg ated acts adopt ed under this Article shall enter into force without dela y and shall apply as long as no 
objection is expressed in accordance with paragraph 2. The notification of a delegat ed 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 delegat ed act in accordance with the procedure 
referred to in Article 264(6). In such a case, the Commission shall repeal the act without dela y following the notification 
of the decision to object by the European Parliament or by the Council. 
Article 266 
Committee procedure 
1. The Commission shall be assisted by the Standing Committ ee 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 . 
4. The Commission shall allow a period of at least six months to elapse between the adoptio n of the respective initial 
implementing acts referred to in Articles 25(3), 120, and 228(2), when those implementing acts relate to the imple men ­
tation of Article 117, and the date on which they start to apply . 
Article 267 
Data protection 
1. Member States shall apply Directive 95/46/EC of the European Parliament and of the Council (1) to the processing 
of personal data carried out in the Member States pursuant to this Regulation. 
2. Regulation (EC) No 45/2001 of the European Parliament and of the Council (2) shall apply to the processing of 
personal data carried out by the Commission pursuant to this Regulation. 
TITLE II 
PENAL TIES 
Article 268 
Penalties 
The Member States shall lay down the rules on penalties applicable to infringe ments of the provisions of this Regulation 
and shall take all measures necessar y to ensure that those rules are implemented . The penalties provided for must be 
effective, propor tionate and dissuasive. 
The Member States shall notify those provisions to the Commission by 22 Apr il 2022 at the latest and shall notify it 
without dela y of any subsequent amendments affecting them. 31.3.2016 L 84/165 Official Jour nal of the European Union EN     
(1)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to 
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). 
(2)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with 
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 
12.1.2001, p. 1). TITLE III 
MEMBER STATES' MEASURES 
Article 269 
Additional or more stringent measures by Member States 
1. In addition to what follows from other provisions in this Regulation, allowing the Member States to adopt national 
measures, Member States may apply within their territori es measures that are additional to, or more stringe nt than, 
those laid down in this Regulation, concer ning: 
(a)  responsibilities for animal health as provided for in Chapt er 3 of Part I (Articles 10 to 17); 
(b)  notificati on within Member States as provided for in Article 18; 
(c)  surveillance as provided for in Chapt er 2 of Part II (Articles 24 to 30); 
(d)  registration, appro val, record-kee ping and registe rs as provided for in Chapt er 1 of Title I (Articles 84 to 107), and 
Chapt er 1 of Title II, of Part IV (Articles 172 to 190); 
(e)  traceability requirements for kept terrestr ial animals and germinal products as provided for in Chapt er 2 of Title I of 
Part IV (Articles 108 to 123). 
2. The national measures referred to in paragraph 1 shall respect the rules laid down in this Regulation and shall not: 
(a)  hinder the movement of animals and products between Member State s; 
(b)  be inconsistent with the rules referred to in paragraph 1. 
PART ΙΧ 
TRANSITIONAL AND FINAL PROVISIONS 
Article 270 
Repeals 
1. Decisions 78/642/EEC, 89/455/EEC and 90/678/EEC, and Directives 79/110/EEC, 81/6/EEC, 90/423/EEC, 
92/36/EEC and 98/99/EC are repealed. 
2. The following acts are repealed as from 21 Apr il 2021: 
—  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, 31.3.2016 L 84/166 Official Jour nal of the European Union EN     —  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, 
—  Directive 2001/89/EC, 
—  Directive 2002/60/EC, 
—  Directive 2002/99/EC, 
—  Directive 2003/85/EC, 
—  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, 
—  Regulation (EU) No 576/2013. 
References to those repealed acts shall be constr ued as references to this Regulation and shall be read in accordance with 
the correlation table set out in Annex V hereto. 
Article 271 
Transitional measures related to the amendment of Regulation (EC) No 1760/2000 and the repeal 
of Regulation (EC) No 21/2004 and Directiv e 2008/71/EC 
1. Notwithstanding Article 270(2) and Article 278 of this Regulation, Articles 1 to 10 of Regulation (EC) 
No 1760/2000, Regulation (EC) No 21/2004, and Directive 2008/71/EC, as well as the acts adopt ed on the basis 
thereof, shall continue to apply , instead of the corresponding Articles in this Regulation, until three years after the date 
of application of this Regulation or an earlier date to be determined in a delegat ed act adopt ed in accordance with 
paragraph 2 of this Article. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
earlier date refer red to in paragraph 1 of this Article. 
That date shall be the date of application of the corresponding rules to be adopt ed pursuant to the delegat ed acts 
provided for in Article 109(2) and Article 119 and the imple menting acts provided for in Article 118 of this Regulation. 31.3.2016 L 84/167 Official Jour nal of the European Union EN     Article 272 
Transitional measures related to the repeals of Directiv es 92/66/EEC, 2000/75/EC, 2001/89/EC, 
2002/60/EC, 2003/85/EC and 2005/94/EC 
1. Notwithstanding Article 270(2) of this Regulation, Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 
2003/85/EC and 2005/94/EC, as well as the acts adopt ed on the basis thereof, shall continue to apply , instead of the 
corresponding Articles in this Regulation, until three years after the date of application of this Regulation or an earlier 
date to be deter mined in a delegat ed act adop ted in accordance with paragraph 2 of this Article. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning the 
earlier date refer red to in paragraph 1 of this Article. 
That date shall be the date of application of the corresponding rules to be adopt ed pursuant to the delegat ed acts 
provided for in Article 47, Articles 48(3), 53(2), 54(3), 55(2) and 58(2), Article 63, Article 64(4), Article 67, and 
Articles 68(2) and 70(3) of this Regulation. 
Article 273 
Amendment of Regulation (EC) No 2160/2003 
In Article 9(3) of Regulation (EC) No 2160/2003 the following wording is added: 
‘Those special measures shall include measures based on the provisions contained in Decision 95/410/EC in its last 
version prior to its repeal and Commission Decisions 2003/644/EC (*) and 2004/235/EC (**) in the versions thereof 
at the time of the repeal of Directive 90/539/EEC.  
(*)Commission Decision 2003/644/EC of 8 Sept ember 2003 establishing additional guarant ees regar ding 
salmonella for consignments to Finland and Sweden of breeding poultr y and day-old chic ks for introduction 
into flocks of breeding poultr y or flocks of productive poultr y (OJ L 228, 12.9.2003, p. 29). 
(**) Commission Decision 2004/235/EC of 1 March 2004 establishing additional guarantees regar ding salmonella 
for consignments to Finland and Sweden of laying hens (OJ L 72, 11.3.2004, p. 86).’. 
Article 274 
Transitional measures related to the date of adoption of certain delegated and implementing acts 
Without prejudice to the date of application provided for in Article 283, the Commission shall adopt the delegat ed acts 
referred to in the first subparagraph of Article 31(5), Articles 32(2), 39, 41(3), 54(3), 55(2), 58(2), 64(4), 67, 68(2), 
74(4), 77(2) and 97(2), Article 122(2), and Articles 131(1), 132(2), 135, 137(2), 146(1), 149(4), 154(1), 162(3), 163(5), 
166(3), 169(5), 181(2), 185(5), 213(1), 216(4), 221(1), 222(3), 224(3), 234(2), 239(1), and the imple menting acts 
referred to in Articles 8 and 9, at the latest on 20 Apr il 2019. In accordance with Article 283, those delegat ed and 
implementing acts shall apply from the date of application set out in that Article. 
Article 275 
Prior review and amendments of Annex II 
The Commission shall, at the latest by 20 Apr il 2019, review the list of diseases contained in Annex II. Should it be 
apparent from that review that an application of the rules set out in this Regulation requires amendments to be made to 
Annex II, by adding to or deleting from the list contained therein, such amendments shall be adopt ed by the 
Commission at the latest by the deadline referred to in the first sentence of this Article. 31.3.2016 L 84/168 Official Jour nal of the European Union EN     Article 276 
Review 
The Commission shall, by 20 Apr il 2019 at the latest, review the existing legislation on the identif ication and 
registration of kept animals of the equine species. 
The Commission shall take the results of that review into account in the framew ork of the application of Articles 118, 
119 and 120. 
Article 277 
Transitional measures related to the repeal of Regulation (EU) No 576/2013 on the non– 
commercial movement of pet animals 
Notwithstanding Article 270(2) of this Regulation, Regulation (EU) No 576/2013 shall continue to apply until 21 Apr il 
2026 in respect of non–commercial movements of pet animals, in place of Part VI of this Regulation. 
Article 278 
Amendments to Regulation (EC) No 1760/2000 
Regulation (EC) No 1760/2000 is amended as follows:  
(1) Articles 1 to 10 are delet ed;  
(2) Article 22 is replaced by the following: 
‘Article 22 
1. Member States shall take all the necessar y measures to ensure compliance with the provisions of this 
Regulation. 
The controls provided for shall be without prejudice to any controls whic h the Commission may carry out pursuant 
to Article 9 of Regulation (EC, Eurat om) No 2988/95. 
Any penalties imposed by the Member State on an operator or organisation mark eting beef shall be effective, 
dissuasive and propor tionat e. 
2. Notwithstanding paragraph 1, where operat ors and organisations marketing beef have labelled beef without 
complying with their oblig ations laid down in Title II, Member State s shall, as appropr iate, and in accordance with 
the principle of propor tionality , require the remo val of the beef from the market. In addition to the penalties 
refer red to in paragraph 1, Member States may: 
(a)  if the meat concer ned conf orms with relevant veteri nary and hygiene rules, author ise that such beef: 
(i)  be placed on the mark et after being properly labelled in accordance with Union requirements; or 
(ii)  be sent directly for processing into products other than those indicated in point 1 of Article 12; 
(b)  order the suspension or withdra wal of the appro val of the operat ors and orga nisations concer ned. 
3. Exper ts from the Commission, in conjunction with the compet ent author ities, shall: 
(a)  verify that Member States comply with the requirements of this Regulation; 
(b)  mak e on–the–spot checks to ensure that the checks are carried out in accordance with this Regulation. 31.3.2016 L 84/169 Official Jour nal of the European Union EN     4. A Member State in whose territory an on–the–spot chec k is carried out shall provide the exper ts from the 
Commission with any assistance they may require in the perf ormance of their task s. The outcome of the checks 
made shall be discussed with the compet ent author ity of the Member State concer ned before a final repor t is drawn 
up and circulated. That repor t shall, where appropr iate, contain recommendations for Member States on the 
impro vement of compl iance with this Regulation.’;  
(3) Article 22b is replaced by the following: 
‘Article 22b 
Exercise of the delegation 
1. The power to adopt delegat ed acts is conferr ed on the Commission subject to the conditions under this 
Article. 
2. The power to adop t delegat ed acts refer red to in Articles 13(6), 14(4) and 15a shall be conferr ed on the 
Commission for a period of five years from 20 Apr il 2016. The Commission shall draw up a repor t in respect of 
the delegation of power not later than nine months before the end of the five-year period. The delegation of power 
shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes 
such extension not later than three months before the end of each period. 
3. The delega tion of power referred to in Articles 13(6), 14(4) and 15a may be revok ed at any time by the 
European Parliament or by the Council. A decision to revok e shall put an end to the delegation of the power 
specif ied 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 specifi ed therein. It shall not affect the validity of any delegat ed acts already in 
force. 
4. As soon as it adopts a delegat ed act, the Commission shall notify it simultaneously to the European Parliament 
and to the Council. 
5. A delegat ed act adopt ed pursuant to Articles 13(6), 14(4) and 15a shall enter into force only if no objection 
has been expressed either by the European Parliament or the Council within a period of two months of notification 
of that act to the European Parliament and the Council or if, before the expir y 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 of the Council.’;  
(4) Article 23 is replaced by the following: 
‘Article 23 
Committee procedure 
1. The Commission shall be assist ed for the imple menting acts adopt ed pursuant to Article 13(6) of this 
Regulation by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation 
(EC) No 178/2002 of the European Parliament and of the Council (*). 
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European 
Parliament and of the Council (**). 
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply . 
Where the opinion of the Committee is to be obtained by written procedure, that procedure shall be term inated 
without result when, within the time–limit for deliver y of the opinion, the chair of the Committee so decides or a 
simple major ity of committee members so requests.  
(*)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down 
the general principles and requirements of food law, establishing the European Food Safety Author ity and laying 
down procedures in matte rs of food safety (OJ L 31, 1.2.2002, p. 1). 
(**) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying 
down the rules and general principles concer ning mechanis ms for control by Member States of the 
Commission's exer cise of implementing powers (OJ L 55, 28.2.2011, p. 13).’. 31.3.2016 L 84/170 Official Jour nal of the European Union EN     Article 279 
Exis ting operat ors and establishments 
1. Establishments and operators register ed or appro ved in accordance with Directive 64/432/EEC, Directive 
88/407/EEC, Directive 89/556/EEC, Directive 90/429/EEC, Directive 91/68/EEC, Directive 92/65/EEC, Regulation (EC) 
No 1760/2000, Regulation (EC) No 21/2004, Directive 2006/88/EC, Directive 2008/71/EC, Directive 2009/156/EC or 
Directive 2009/158/EC before the date of application of this Regulation shall be deemed to be registere d or appro ved, as 
required, in accordance with this Regulation and shall, as such, be subject to the relevant obligations provided for under 
this Regulation. 
2. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning rules 
necessar y to ensure a smooth transition from the rules existing prior to this Regulation referred to in paragraph 1 of 
this Article, in order in particular to prote ct acquired rights and legitimate expectations of natural and legal persons 
concer ned. 
Article 280 
Exis ting disease–free Member States, zones and compar tments and exist ing Member State 
eradication and surveillance prog rammes 
1. Member States and zones with an appro ved disease–free status for one or more of the liste d diseases referred to in 
points (b) and (c) of Article 9(1), for one or more of the relevant animal species, in accordance with Directive 
64/432/EEC, Directive 91/68/EEC, Directive 92/65/EEC, Directive 2006/88/EC, Directive 2009/156/EC or 
Directive 2009/158/EC, shall be deemed to have an appro ved disease–free status in accordance with this Regulation and 
shall, as such, be subject to the relevant oblig ations provided for under this Regulation. 
2. Member State s and zones with an appro ved eradication programme or surveillance programme for one or more of 
the liste d diseases refer red to in points (b) and (c) of Article 9(1), for one or more of the relevant animal species, in 
accordance with Directive 64/432/EEC, Directive 91/68/EEC, Directive 92/65/EEC, Directive 2006/88/EC, Directive 
2009/156/EC or Directive 2009/158/EC, shall be deemed to have an appro ved eradication programme in accordance 
with this Regulation and shall, as such, be subject to the relevant oblig ations provided for under this Regulation. 
3. Appro ved compar tments with an appro ved disease–free status for one or more of the listed diseases referred to in 
points (a), (b) or (c) of Article 9(1), in accordance with Directives 2005/94/EC and 2006/88/EC, shall be deemed to have 
a recognised disease-free status under Article 37 of this Regulation and shall, as such, be subject to the relevant 
oblig ations provided for under this Regulation. 
4. The Commission shall be empo wered to adopt delegat ed acts in accordance with Article 264 concer ning rules 
necessar y in order to ensure a smooth transition from the rules existing prior to this Regulation refer red to in 
paragraphs 1, 2 and 3. 
Article 281 
Relation with acts concer ning official controls 
In the event of any conf lict between the provisions of this Regulation and the provisions of Regulation (EC) 
No 882/2004, Council Directives 89/608/EEC (1), 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/93/EC (2) and 97/78/EC 
and Decision 92/438/EEC, the provisions of this Regulation shall prevail. 
Article 282 
Evaluation 
The Commission shall evaluate this Regulation together with the delegat ed acts referred to in Article 264 and submit the 
results of the evaluation in a repor t to the European Parliament and to the Council no later than 22 Apr il 2026. 31.3.2016 L 84/171 Official Jour nal of the European Union EN     
(1)Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative author ities of the Member States 
and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinar y and zootec hnical 
matt ers (OJ L 351, 2.12.1989, p. 34). 
(2)Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products (OJ L 13, 16.1.1997, p. 28). Article 283 
Entr y into force and application 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the 
European Union. 
It shall apply from 21 Apr il 2021, excep t for Articles 270(1) and 274, which shall apply from the date of its entr y into 
force. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Strasbourg, 9 March 2016. 
For the European Parliament 
The President 
M. SCH ULZ  For the Council 
The President 
J.A. HENNIS-PL ASSC HAERT   31.3.2016 L 84/172 Official Jour nal of the European Union EN     ANNEX I 
SPECIES OF PET ANIMALS 
PART A 
Dogs (Canis lupus familiar is) 
Cats (Felis silvestris catus) 
Ferrets (Mustela putor ius furo) 
PART B 
Invertebr ates (excep t bees, molluscs belonging to the phylum Mollusca and crustaceans belonging to the subph ylum 
Crustacea) 
Ornamental aquatic animals 
Amphibians 
Repti les 
Birds: specimens of avian species other than fowl, turk eys, guinea fowl, ducks, geese, quails, pigeon s, pheasants, 
partridges and ratites (Ratitae). 
Mammals: rodents and rabbits other than those intended for food production.  31.3.2016 L 84/173 Official Jour nal of the European Union EN     ANNEX II 
LIST OF DISEASES 
—  Rinder pest (cattle plague) 
—  Sheep and goat plague 
—  Swine vesicular disease 
—  Bluet ongue 
—  Teschen disease 
—  Sheep pox or goat pox 
—  Rift Valley fever 
—  Lump y skin disease 
—  Vesicular stomatitis 
—  Venezuelan equine viral encephalom yelitis 
—  Haemor rhagic disease of deer 
—  Contagious bovine pleuropneumonia 
—  Newcas tle disease 
—  Bovine tuberculosis 
—  Bovine brucellosis (B. abor tus) 
—  Ovine and capr ine brucellosis (B. melitensis) 
—  Anthrax 
—  Rabies 
—  Echinococcosis 
—  Transmissible spongif orm encephalopathies (TSE) 
—  Cam pylobacter iosis 
—  Listeriosis 
—  Salmonellosis (zoonotic salmonella) 
—  Trichin ellosis 
—  Veroto xigenic E. coli 
—  Viral haemor rhagic septicæm ia (VHS) 
—  Infectious haemato poietic necrosis (IHN) 
—  Epizootic haematopoietic necrosis in fish (EHN) 
—  Epizootic ulcerative syndrome in fish (EUS) 
—  Infection with Bonamia exitiosa 
—  Infection with Perkinsus marinus 
—  Infection with Micr ocytos mackini 
—  Taura syndrome in crustaceans 31.3.2016 L 84/174 Official Jour nal of the European Union EN     —  Yellowhead disease in crustaceans 
—  Koi herpes virus disease (KHV) 
—  Infectious salmon anaemia (ISA) 
—  Infection with Mar teilia refrin gens 
—  Infection with Bonamia ostreae 
—  Whit e spot disease in crustaceans  31.3.2016 L 84/175 Official Jour nal of the European Union EN     ANNEX III 
SPECIES OF UNGUL ATES 
Taxon 
Order Family Genera/Species 
Perissodactyla Equidae Equus spp. 
Tapiridae Tapirus spp. 
Rhinocer itidae Ceratother ium spp., Diceror hinus spp., Diceros spp., Rhinoceros spp. 
Artiodacty la Antilocapr idae Antilocapr a ssp. 
Bovidae Addax ssp., Aepyceros ssp., Alcelaphus ssp., Ammelaphus ssp., Ammodorcas ssp., 
Ammotr agus ssp., Antidorcas ssp., Antilope ssp., Arbitr agus ssp., Beatr agus ssp., 
Bison ssp., Bos ssp.(including Bibos, Novibo s, Poephagus), Boselaphus ssp., 
Bubalus ssp. (including Anoa), Budor cas ssp., Capr a ssp., Cephalophus ssp., 
Connochaetes ssp., Damaliscus ssp.(including Beatr agus), Dorcatr agus ssp., 
Eudor cas ssp., Gazella ssp., Hemitr agus ssp., Hippotr agus ssp., Kobus ssp., Lito­
cranius ssp., Madoqua ssp., Naemorhedus ssp. (including Nemorhaedus and 
Capr icornis), Nang er ssp., Neotr agus ssp., Nilgir itragus ssp., Oreamnos ssp., 
Oreo tragus ssp., Oryx ssp., Ourebia ssp., Ovibos ssp., Ovis ssp., Pantholops ssp., 
Philantomba ssp., Pelea ssp., Procapra ssp., Pseudois ssp., Pseudor yx ssp., Raphi ­
cerus ssp., Redunca ssp., Rupicapra ssp., Saig a ssp., Sigmocero s–Alecelaphus ssp., 
Strepticeros ssp., Sylvicapr a ssp., Syncer us ssp., Taurotr agus ssp., Tetracerus ssp., 
Tragelaphus ssp. (including Boocer us). 
Camelidae Camelus ssp., Lama ssp., Vicugna ssp. 
Cervidae Alces ssp., Axis–Hy elaphus ssp., Blastocer us ssp., Capreolus ssp., Cervus ssp., 
Dama ssp., Elaphodus ssp., Elaphur us ssp., Hippocamelus ssp., Hydropotes ssp., 
Mazama ssp., Meg amuntiacus ssp., Muntiacus ssp., Odocoileus ssp., Ozoto ­
ceros ssp., Prze walskium ssp., Pudu ssp., Rangifer ssp., Rucervus ssp., Rusa ssp. 
Giraffidae Giraffa ssp., Okap ia ssp. 
Hippopotamidae Hexapro todon–Choeropsis ssp., Hippopotamus ssp. 
Moschidae Moschus ssp. 
Suidae Babyrousa ssp., Hylochoer us ssp., Phacochoer us ssp., Porcula ssp., Potamo ­
choer us ssp., Sus ssp. 
Tayassuidae Catagonus ssp., Pecari–Tayassu ssp. 
Tragulidae Hyemoschus ssp., Tragulus–Moschiola ssp. 
Proboscidea Elephantidae Elephas ssp., Loxodon ta ssp.   31.3.2016 L 84/176 Official Jour nal of the European Union EN     ANNEX IV 
CRITERIA FOR THE APPLIC ATION OF THE DISEASE PREVENTION AND CONTR OL RULES REFERRED TO 
IN ART ICLE 9(1) TO DISEASES LISTED IN ACCOR DANCE WITH ARTICLE 5 
The scope of this Annex is to detail the criteria to be considered by the Commission when determi ning the disease 
prevention and control rules to be applied to the diffe rent catego ries of diseases liste d in accordance with Article 5. 
The process of categor isation shall take into account the profile of the disease in question, the level of the impa ct of that 
disease on animal and public health, animal welf are and the econom y, and the availability , feasibility and effectiveness of 
the diagnostic tools and differ ent sets of disease prevention and control measures provided for in this Regulation with 
respect to the disease. 
Section 1 
Criter ia for the application of the disease prev ention and control rules refer red to 
in point (a) of Article 9(1) 
The diseases for whic h the disease prevention and control rules refer red to in point (a) of Article 9(1) apply shall be 
considered to have the most severe animal health, public health, economic, social or envi ronmental impacts on the 
Union. Those diseases need to fulfil the following criteria: 
(a)  the disease in question is: 
(i)  not present in the territory of the Union; 
(ii)  present only in excep tional cases (irregular introductions); or 
(iii)  present in only in a very limited part of the territory of the Union; 
and 
(b)  the disease in question is highly transmissible; in addition to direct and indirect transmission, there may also be 
possibilities of airbor ne, waterbor ne or vect or–bor ne spread. The disease may affect multiple species of kept and 
wild animals, or a sing le species of kept animals of economic impor tance, and may result in high morbidity and 
signif icant mor tality rates. 
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of the following criteria: 
(c)  the disease in question has a zoonotic pote ntial with signif icant consequences for public health, including epidemic 
or pandemic pote ntial or possible significant threats to food safet y; 
(d)  the disease in question has a signif icant impa ct on the econom y of the Union, causing substantial costs, mainly 
relat ed to its direct impact on the health and productivity of animals; 
(e)  the disease in question has a signif icant impact on one or more of the following: 
(i)  society , with in particular an impact on labour mark ets; 
(ii)  animal welf are, by causing suffering to large numbers of animals; 
(iii)  the environment, due to the direct impact of the disease or due to the measures take n to control it; 
(iv)  in the long term , biodiversity or the protect ion of endange red species or breeds, including the possible 
disappearance of, or long-t erm damag e to, those species or breeds. 
Section 2 
Criter ia for the application of the disease prev ention and control rules refer red to 
in point (b) of Article 9(1) 
The diseases for whic h the disease prevention and control rules refer red to in point (b) of Article 9(1) apply shall be 
controlled in all Member States with the goal of eradicating them throughout the Union. 31.3.2016 L 84/177 Official Jour nal of the European Union EN     Those diseases need to fulfil the following criteria: 
(a)  the disease in question is endemic in nature and is present in the whole or part of the Union territory. However , 
several Member States or zones of the Union are free of the disease; and 
(b)  the disease is moderately to highly transmissible; in addition to direct and indirect transmission, there may also be 
possibilities of airbor ne, water borne or vect or–bor ne spread. It may affect sing le or multiple animal species and may 
result in high morbidity , with in general low mor tality . 
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of the following criteria: 
(c)  the disease in question has a zoonotic pote ntial with signif icant consequences for public health, including epidemic 
poten tial or possible signif icant threats to food safety; 
(d)  the disease in question has a signif icant impa ct on the econom y of the Union causing substantial costs, mainly 
relat ed to its direct impact on the health and productivity of animals; 
(e)  the disease has a signif icant imp act on one or more of the following: 
(i)  society , with in particular an impact on labour mark ets; 
(ii)  animal welf are, by causing suffering to large numbers of animals; 
(iii)  the environment, due to the direct impact of the disease or due to the measures take n to control it; 
(iv)  in the long term , biodiversity or the protect ion of endange red species or breeds, including the possible 
disappearance of, or long-t erm damag e to, those species or breeds. 
A disease to whic h the measures refer red to in point (a) of Article 9(1) apply , whic h has not been successfully and 
promp tly eradicat ed in a part of the Union, and has, in that part of the Union, obtained an endemic charact er, may be 
subject to disease prevention and control measures under point (b) of Article 9(1), in that part of the Union. 
Section 3 
Criter ia for the application of the disease prev ention and control rules refer red to 
in point (c) of Article 9(1) 
The diseases for which the disease prevention and control rules referred to in point (c) of Article 9(1) apply are of 
relevance to some Member States and measures are needed to prevent them from spreading to parts of the Union that 
are officiall y disease-free or that have eradication programmes for the liste d disease in question. 
Those diseases need to fulfil the following criteria: 
(a)  in terrestrial animals, the disease in question is endemic in nature and is present in the whole or part of the Union 
territory ; or in aquatic animals, several Member State s or zones of the Union are free of the disease; and 
(b)  (i)  in terrestrial animals, the disease in question is moderate ly to highly transmissible, mainly through direct and 
indirect transmission. The disease mainly affects multiple or sing le animal species, usually does not result in high 
morbidity , and has a negligible or no mor tality rate. Often the most obser ved effect is production loss; 
(ii)  in aquatic animals, the disease is moderate ly to highly transmissible, mainly through direct and indirect 
transmission. The disease affects multiple or sing le animal species and may result in high morbidity and usually 
low mor tality . Often the most obser ved effect is production loss. 
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of the following criteria: 
(c)  the disease in question has a zoonotic pote ntial with significant consequences for public health, or possible threats 
to food safety ; 
(d)  the disease in question has a signif icant impact on the econom y of parts of the Union, mainly relat ed to its direct 
impact on certain types of animal production system s. 31.3.2016 L 84/178 Official Jour nal of the European Union EN     (e)  the disease in question has a signif icant impact on one or more of the following: 
(i)  society , with, in particular , an impact on labour mark ets; 
(ii)  animal welf are, by causing suffering to large numbers of animals; 
(iii)  the environment, due to the direct impact of the disease or of the measures taken to control it; 
(iv)  in the long term , biodiversity or the protect ion of endange red species or breeds, including the possible 
disappearance of, or long-t erm damag e to, those species or breeds. 
Section 4 
Criter ia for the application of the disease prev ention and control rules refer red to 
in point (d) of Article 9(1) 
The disease prevention and control rules referred to in point (d) of Article 9(1) shall apply to diseases that fulfil the 
criteria set out in Section 1, 2 or 3 and to other diseases fulfilling the criteria set out in Section 5 where the risk posed 
by the disease in question can be effectively and propor tionate ly mitig ated by measures concer ning movements of 
animals and products in order to prevent or limit its occur rence and spread. 
Section 5 
Criter ia for the application of the disease prev ention and control rules refer red to 
in point (e) of Article 9(1) 
The disease prevention and control rules referred to in point (e) of Article 9(1) shall apply to diseases that fulfil the 
criteria set out in Sections 1, 2 or 3 and to other diseases where surveillance of the disease is necessar y for reasons 
relating to animal health, animal welf are, human health, the econom y, society or the environment.  31.3.2016 L 84/179 Official Jour nal of the European Union EN     ANNEX V 
CORREL ATION TABLE REFERRED TO IN ART ICLE 270 (2) 
1.Directive 64/432/EEC 
Directive 64/432/EEC This Regulation 
Article 1 — 
Article 2 Articles 4 (par tially), 21, 153(3) and 220(3) 
Article 3(1) Articles 124 and 126 
Article 3(2) Articles 124 (2), 126(1) and 149(3) and (4) 
Article 4(1) Article 126(1)(c) 
Article 4(2) and (3) Article 125(1) and (2) 
Article 5(1) Articles 143(1), 145 and 146 
Article 5(2) Article 149(3) and (4) 
Article 5(2)(a) Article 147(a) 
Article 5(2)(b) Article 144(1)(b) 
Article 5(3) — 
Article 5(4) Article 153(1) and (2) 
Article 5(5) Article 147(a) 
Article 6 Articles 130, 131 and 132 
Article 6a — 
Article 7 Articles 126(1)(c),132, 134(a) and 135 
Article 8 Articles 18, 19, 20 and 23(a) 
Article 9 Articles 31(1), (3)(a) and (5), 32, 33 and 36 
Article 10 Articles 31(2) and (3)(b), 32, 33 and 36 
Article 11(1) Articles 94(1)(a), 97 and 98 
Article 11(2) Articles 102, 106 and 107 
Article 11(3) Articles 98 and 99 
Article 11(4) Article 100 
Article 11(5) and (6) Article 97(1)(d) and (2)(d) 
Article 12(1) Article 125 
Article 12(2) Articles 104 and 106 
Article 12(3) Article 125(1)(a) and (b) 
Article 12(4) Article 143 
Article 12(5) and (6) — 
Article 13(1) and (2) Articles 90, 92, 93(c), 94, 97, 98, 99, 102, 106 and 107 
Article 13(3) Article 100 
Article 13(4) — 31.3.2016 L 84/180 Official Jour nal of the European Union EN     Directive 64/432/EEC This Regulation 
Article 13(5) and (6) Article 101 
Article 14(1) and (2) — 
Article 14(3)A and B — 
Article 14(3)C Article 109(1)(a) and (c) 
Article 14(4) to (6) — 
Article 15(1) Article 268 
Article 15(2) to (4) — 
Article 16 — 
Article 17 — 
Article 17a — 
Article 18 Article 109(1)(a) and (c) 
Article 19 — 
Article 20 —  
2.Directive 77/391/EEC 
Directive 77/391/EEC This Regulation 
Article 1 — 
Article 2(1) Article 31(1) 
Article 2(2) Articles 32, 33 and 36(1) 
Article 2(3) Article 34 
Article 2(4) Articles 36 and 41 
Article 3(1) Article 31(1) 
Article 3(2) Articles 32, 33 and 36(1) 
Article 3(3) Article 34 
Article 3(4) Articles 36 and 41 
Article 4 Articles 31(1), 32, 33, 34, 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 —  31.3.2016 L 84/181 Official Jour nal of the European Union EN     3.Directive 78/52/EEC 
Directive 78/52/EEC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3(1) Articles 31(1) and 32 
Article 3(2) — 
Article 3(3) — 
Article 3(4) Articles 31(1) and 32 
Article 4 Articles 32, 35, 102(2) and (4) and 112 
Article 5 Articles 18, 46 and 47 
Article 6(1) Articles 72 to 76 
Article 6(2) Articles 77 and 78 
Article 6(3) Articles 79 and 80 
Article 7 Articles 79 and 80 
Article 8 Articles 79 and 80 
Article 9 Articles 79 and 80 
Article 10 Articles 79 and 80 
Article 11 Articles 79 and 80 
Article 12 Articles 79 and 80 
Article 13 Articles 18, 46 and 47 
Article 14(1) Articles 72 to 76 
Article 14(2) Articles 77 and 78 
Article 14(3) Articles 79 and 80 
Article 15 Articles 79 and 80 
Article 16 Articles 79 and 80 
Article 17 Articles 79 and 80 
Article 18 Articles 79 and 80 
Article 19 Articles 79 and 80 
Article 20 Articles 79 and 80 
Article 21 — 
Article 22 Articles 18, 19, 20, 46 and 47 
Article 23 Articles 79 and 80 
Article 24 Articles 79 and 80 
Article 25 Articles 79 and 80 
Article 26 Articles 79 and 80 
Article 27 Articles 124(1) and 126(1)(c) 
Article 28 — 
Article 29 — 
Article 30 —  31.3.2016 L 84/182 Official Jour nal of the European Union EN     4.Directive 80/1095/EEC 
Directive 80/1095/EEC This Regulation 
Article 1 Articles 31(1) and 36 
Article 2 Article 4 (par tially) 
Article 3 Articles 31(1) and 35 
Article 3a Articles 31(1) and 35 
Article 4 Articles 32, 33 and 35 
Article 4a Articles 32, 33 and 35 
Article 5 — 
Article 6 Articles 31(1)(b), 31(3) and 32 
Article 7 Articles 36, 39 and 40 
Article 8 Articles 41 and 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 (par tially) 
Article 3 Articles 19, 21, 22 and 23 
Article 4 Articles 19, 20, 21, 22 and 23 
Article 5 Article 23 
Article 6 — 
Article 7 — 
Article 8 —  
6.Directive 88/407/EEC 
Directive 88/407/EEC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3 Articles 159 and 160 
Article 4 Article 160 
Article 5 Articles 94, 97, 100 and 101 
Article 6(1) Articles 161 and 162 
Article 6(2), (3) and (4) Article 258 
Article 8 Articles 229(1)(a) and 230 
Article 9 Articles 229(1)(b) and 233 31.3.2016 L 84/183 Official Jour nal of the European Union EN     Directive 88/407/EEC This Regulation 
Article 10 Articles 229(1)(c), 234 and 236 
Article 11 Articles 229(1)(d), 237 and 238 
Article 12 Articles 260 to 262 
Article 15 Articles 257 to 259 
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 (par tially) 
Article 3 Article 159, 160, 161 
Article 5(1) Articles 94 and 97 
Article 5(2) Article 101 
Article 5(2a) and (3) Articles 97, 98 and 100 
Article 6 Articles 161 and 162 
Article 7 Articles 229(1)(a) and 230 
Article 8 Articles 229(1)(b) and 233 
Article 9 Articles 229(1)(c), 234 and 236 
Article 10 Articles 229(1)(d), 237 and 238 
Article 11 Articles 260 to 262 
Article 14 Articles 257 to 259 
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 (par tially) 
Article 3 Articles 159 and 160 
Article 4 — 31.3.2016 L 84/184 Official Jour nal of the European Union EN     Directive 90/429/EEC This Regulation 
Article 5(1) Articles 94, 97, 98 and 100 
Article 5(2) Article 101 
Article 6(1) Articles 161 and 162 
Article 6(2) Article 258 
Article 7 Articles 229(1)(a) and 230 
Article 8 Articles 229(1)(b) and 233 
Article 9 Articles 229(1)(c), 234 and 236 
Article 10 Article 229(1)(d), 237 and 238 
Article 11(1) Article 229 
Article 11(2) and (3) Article 260 
Article 12 Article 237 
Article 13 — 
Article 14 — 
Article 15 Articles 257 to 262 
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 (par tially), 21, 153(3) and 220(3) 
Article 3(1), (2), (3) and (5) Articles 126(1)(b), 130 and 131 
Article 3(4) Article 139 
Article 4(1) Articles 124(2)(b), 126(1), 130, 131 and 149(3) and (4)(a) 
and (b) 
Article 4(2) Article 128 
Article 4(3) Article 131 
Article 4a Articles 130 and 131 
Article 4b(1) and (2) Articles 130 and 131 
Article 4b(3) Article 126(2) 
Article 4b(4) Article 133 
Article 4b(5) Article 132 
Article 4b(6) Articles 124(1), 125 and 126(1)(b) 
Article 4c(1) and (2) Articles 130 and 131 31.3.2016 L 84/185 Official Jour nal of the European Union EN     Directive 91/68/EEC This Regulation 
Article 4c(3) Articles 133 and 135 
Article 5 Article 131 
Article 6 Articles 131 and 145(1)(e) 
Article 7(1) to (3) Articles 31, 32, 33 and 35 
Article 7(4) — 
Article 8(1) to (3) Articles 36, 39 and 40 
Article 8(4) — 
Article 8a(1) Articles 94(1)(a), 97, 98 and 134 
Article 8a(2) Article 102 and 106 
Article 8a(3) Articles 98, 99 and 101 
Article 8a(4) Article 100 
Article 8a(5) Article 97(1)(d) and (2)(d) 
Article 8b(1) Articles 84, 90, 92, 93(c), 94(1)(a), 97, 98, 102, 105 
and 134 
Article 8b(2) Articles 94(1)(a), 97 and 98 
Article 8b(3) Article 100 
Article 8b(4) — 
Article 8c(1) Articles 87 and 125 
Article 8c(2) Article 104 
Article 8c(3) Articles 125(1)(a) and 126(1)(b) 
Article 8c(4) and (5) — 
Article 9(1) to (4) Articles 143, 145, 146, 147, 148, 149 and 153 
Article 9(7) Article 153 
Article 10 — 
Article 11 — 
Article 12 Article 144(b) 
Article 14 — 
Article 15 — 
Article 17 — 
Article 18 —  
10. Decision 91/666/EEC 
Decision 91/666/EEC This Regulation 
Article 1 Article 48(1) and (3) 
Article 2 — 
Article 3 Article 48 
Article 4 Articles 48, 49 and 50 
Article 5 Articles 48(3) and 50 31.3.2016 L 84/186 Official Jour nal of the European Union EN     Decision 91/666/EEC This Regulation 
Article 6 Articles 16 and 48(2)(c) and (3)(b) 
Article 7 Articles 48(3) and 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 (par tially) 
Article 3 Article 18 
Article 4 Articles 53 to 57 and 59 
Article 5 Articles 46 and 47 
Article 6 Articles 60 to 68 
Article 7(1) Article 57 
Article 7(2) Article 43(2)(d) 
Article 8 Article 64 
Article 9 Articles 65, 66 and 67 
Article 10 Articles 65, 66 and 67 
Article 11 Articles 67 and 68 
Article 12 Article 71(1) 
Article 13 Article 65(2) 
Article 14 — 
Article 15 — 
Article 16 — 
Article 17 Articles 43 and 44 
Article 18 — 
Article 19 — 
Article 20 — 
Article 21 — 
Article 22 —  31.3.2016 L 84/187 Official Jour nal of the European Union EN     12. Directive 92/65/EEC 
Directive 92/65/EEC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3 Articles 170, 171 and 269 
Article 4 Articles 124, 126, 18, 31, 84, 93(a) and 151 
Article 5 Articles 95, 97,136, 137, 143, 144 and 149 
Article 6(A) Articles 124, 126, 130, 131, 137, 140 and 143 to 146 
Article 6(B) — 
Article 7(A) Articles 124, 126, 130, 131, 137, 140 and 143 to 146 
Article 7(B) — 
Article 8 Articles 124, 126, 136 and 143 to 146 
Article 9 Articles 124, 126, 136 and 143 to 146 
Article 10(1) to (4) Articles 124, 126, 136 and 143 to 146 
Article 10(5) to (7) — 
Article 10a — 
Article 11(1) Article 157 
Article 11(2) and (3) Articles 157, 159, 160 and 143 to 146 
Article 11(4) Articles 97 and 101 
Article 11(5) Article 164 
Article 12(1) — 
Article 12(2) Articles 257 to 259 
Article 12(3) Articles 84, 90, 92, 93(c), 102 and 106 
Article 12(4) Articles 143 to 149 and 152 to 154 
Article 12(5) — 
Article 12(6) Article 268 
Article 13(1) Articles 136, 143 to 149 and 151 
Article 13(2) Articles 95, 97 and 98 to 101 
Article 14 Articles 31, 32 and 33 
Article 15 Articles 36, 39, 40 and 41 
Article 16 Articles 229(1) and 234(1) 
Article 17(1) Article 229(1) 
Article 17(2) Articles 229(1)(a), 230 and 233 
Article 17(3) Articles 230, 233 and 234 
Article 17(4) Article 230 
Article 17(5) and (6) — 
Article 18(1), first line Article 237 
Article 18(1), 2nd to 4th line — 
Article 18(2) Article 234(3) 
Article 19 Articles 234 and 239 31.3.2016 L 84/188 Official Jour nal of the European Union EN     Directive 92/65/EEC This Regulation 
Article 20 Articles 229(2) and 260 to 262 
Article 21 Articles 144, 146, 162(4) and (5), 209, 211 and 213 
Article 22 — 
Article 23 Articles 140 and 205 
Article 24 Articles 229(1)(d), 237 and 239(2) 
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 (par tially) 
Article 3 Article 18 
Article 4 Articles 53 to 56 and 59 
Article 5 Articles 60 to 63 
Article 6 Article 63 
Article 7 Articles 57 and 43(2)(d) 
Article 8 Articles 55 and 56 
Article 9(1) Article 64 
Article 9(2) to (7) Articles 65 to 68 
Article 10 Articles 65, 66 and 67 
Article 11 Articles 67(b) and 68(1)(b) and (2)(a) 
Article 12 Articles 54, 61(1)(h) and 63(c) 
Article 13 Article 65(2) 
Article 14 — 
Article 15 — 
Article 16 Articles 46, 47 and 69 
Article 17 Article 47 
Article 18 Articles 65(1)(e), 67(a) and 69 
Article 19(1) to (3) Articles 53 to 56 and 59 
Article 19(4) Articles 57 and 60 to 63 
Article 19(5) Article 71(2) 31.3.2016 L 84/189 Official Jour nal of the European Union EN     Directive 92/66/EEC This Regulation 
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 (par tially) 
Article 3 Articles 166, 222, 227(c)(iv) and 228 
Article 4(1) Articles 166, 222, 227(c)(iv) and 228 
Article 4(2) — 
Article 5 Articles 166 and 222 
Article 6 Article 16(1)(b) and (2)(b) 
Article 7(1) — 
Article 7(2) Articles 257 to 259 
Article 7(3) and (4) — 
Article 7(5) Article 268 
Article 8 — 
Article 9 Articles 229 and 234 
Article 10(1) to (4) and (6) Articles 229, 234, 237 and 239 
Article 10(5) — 
Article 11 Article 239(2)(c)(ii) 
Article 12 — 
Article 13 Article 239(2)(c)(i) 
Article 14 — 
Article 15 — 
Article 16 Article 239(2)(c)(v) 
Article 17 — 
Article 18 — 
Article 19 — 
Article 20 —  31.3.2016 L 84/190 Official Jour nal of the European Union EN     15. Directive 92/119/EC 
Directive 92/119/EC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3 Article 18 
Article 4 Articles 53 to 57 and 59 
Article 5 Articles 60 to 63 
Article 6 Articles 70 and 71(2) 
Article 7 Article 63 
Article 8 Articles 57 and 43(2)(d) 
Article 9 Articles 55 and 57 
Article 10 Articles 64 and 71(3) 
Article 11 Articles 65 to 68 and 71(2) 
Article 12 Articles 65 to 68 and 71(2) 
Article 13 Article 67(a) 
Article 14 Articles 65(2) and 71(1) and (3) 
Article 15 — 
Article 16 Articles 63(b), 67(b) and 68(1)(b) and (2)(a) 
Article 17 — 
Article 18 — 
Article 19 Articles 46, 47 and 69 
Article 20 Articles 43 and 44 
Article 21 — 
Article 22 — 
Article 23 — 
Article 24 — 
Article 25 — 
Article 26 — 
Article 27 — 
Article 28 —  
16. Decision 95/410/EC 
Decision 95/410/EC This Regulation 
Article 1 Articles 130 to 132 and 273 
Article 2 Article 131(1)(c) 
Article 3 Articles 143, 145 and 146 
Article 4 — 
Article 5 — 
Article 6 —  31.3.2016 L 84/191 Official Jour nal of the European Union EN     17. Directive 2000/75/EC 
Directive 2000/75/EC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3 Article 18 
Article 4(1) and (2) Articles 54 and 55 
Article 4(3) Article 53 
Article 4(4) Article 56 
Article 4(5) Article 70 
Article 4(6) Article 59 
Article 5 Articles 46 and 47 
Article 6 Articles 60 to 64, 71(2) and 69 
Article 7 Article 57 
Article 8 Articles 64, 68 and 71(3) 
Article 9 Articles 65, 67, 69 and 71(3) 
Article 10(1) Articles 65 and 67 
Article 10(2) Articles 46 and 47 
Article 11 — 
Article 12 Article 71(3) 
Article 13 Article 71(1) 
Article 14 Article 65(2) 
Article 15 — 
Article 16 — 
Article 17 — 
Article 18 Articles 43 and 44 
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 108 
Article 2 Article 4 (par tially) 
Article 3 Articles 108(3) and 111 
Article 4 Articles 112(a), 118, 119 and 120 
Article 4a Article 118(1)(a) and (2)(a) 
Article 4b Article 118(2)(e) 31.3.2016 L 84/192 Official Jour nal of the European Union EN     Regulation (EC) No 1760/2000 This Regulation 
Article 4c Article 118(1)(a) and (2)(a) 
Article 4d Article 118(1)(a) 
Article 5 Articles 109(1)(a) and 118(1)(b) 
Article 6 Articles 110(1)(b), 112(b) and 118(1)(c) 
Article 6a Article 110(2) 
Article 7(1) Articles 102, 106, 107 and 112(d) 
Article 7(2) Article 118(2)(a) 
Article 7(3) and (4) Article 102(3) 
Article 7(5) Article 102(4) 
Article 7(6) Article 106 
Article 9a Articles 11 and 13(2) 
Article 10(a) to (c) Articles 118, 119 and 120 
Article 10(d) and (e) — 
Article 10(f) Article 270 
Article 11 — 
Article 12 — 
Article 13 — 
Article 14 — 
Article 15 — 
Article 15a — 
Article 22 — 
Article 22a — 
Article 22b — 
Article 23 — 
Article 23a — 
Article 23b — 
Article 24 — 
Article 25 —  
19. Directive 2001/89/EC 
Directive 2001/89/EC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3 Articles 18, 19, 20 and 23 
Article 4 Articles 54 to 56 and 59 
Article 5 Articles 60 to 63 and 71(2) and (3) 
Article 6 Articles 63 and 71 
Article 7 Articles 62, 63, 65(1)(b) and 67 
Article 8 Article 57 31.3.2016 L 84/193 Official Jour nal of the European Union EN     Directive 2001/89/EC This Regulation 
Article 9 Article 64 
Article 10 Articles 65 to 68 
Article 11 Articles 65 to 68 
Article 12 Articles 61(1)(f), 63(b), 65(1)(f), 67(b) and 68(1)(b)  
and (2)(a) 
Article 13 Articles 61(3), 63(d) and 68(2)(a) and (c) 
Article 14 Articles 62 and 63 
Article 15 Article 70 
Article 16 Article 70 and Articles 31 to 35 
Article 17 Articles 16, 17(2), 54(2) and (3), 58(2), 61(1)(g) and (h), 
63(c), 65(1)(b) and 67(c) 
Article 18 Articles 16, 46 47, 48 and 52 
Article 19 Articles 65(1)(e), 67 and 69 
Article 20 Article 70 
Article 21 — 
Article 22 Articles 43 and 44 
Article 23 Articles 43(2)(d) and 44 
Article 24 — 
Article 25 — 
Article 26 — 
Article 27 — 
Article 28 — 
Article 29 — 
Article 30 — 
Article 31 — 
Article 32 —  
20. Directive 2002/60/EC 
Directive 2002/60/EC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3 Articles 18, 19, 20 and 23 
Article 4 Articles 54 to 56 and 59 
Article 5 Articles 60 to 63 and 71(2) and (3) 
Article 6 Articles 63 and 71 
Article 7 Articles 62 and 63 
Article 8 Article 57 
Article 9 Article 64 31.3.2016 L 84/194 Official Jour nal of the European Union EN     Directive 2002/60/EC This Regulation 
Article 10 Articles 65 to 68 
Article 11 Articles 65 to 68 
Article 12 Article 61(1)(f), 63(b), 65(1)(f), 67(b) and 68(1)(b) 
Article 13 Articles 61(3), 63(d) and 68(2)(a) and (c) 
Article 14 Articles 62 and 63 
Article 15 Article 70 
Article 16 Article 70 and Articles 31 to 35 
Article 17(1) Articles 61(1)(f), 63, 65(1)(f) and (i), and 67(a) and (d) 
Article 17(2) and (3) Article 71(2) and (3) 
Article 18 Articles 16, 17(2), 54(2) and (3), 58(2), 61(1)(g) and (h), 
63(c), 65(1)(b) and 67(c) 
Article 19 Articles 16, 46 and 47 
Article 20 — 
Article 21 Articles 43 and 44 
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 (par tially) 
Article 3 Articles 166, 222 and 227(c)(iv) 
Article 4 Articles 65(1)(c),(d), (g),(h) and (i), 67, 166, 222, 227(c)(iv) 
and 228(1) 
Article 5 Articles 167, 168, 223, 224 and 227(d)(iii) 
Article 6 — 
Article 7 Article 234(1) and (2) 
Article 8 Articles 230, 231 and 232 
Article 9 Articles 237 and 238 
Article 10 — 31.3.2016 L 84/195 Official Jour nal of the European Union EN     Directive 2002/99/EC This Regulation 
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 (par tially) 
Article 3 Articles 18, 19, 20 and 23 
Article 4 Articles 54 to 56 
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 and 63 
Article 11 Articles 61(1)(f), 63(b), 65(1)(f), 67(b) and 68(1)(b) 
Article 12 Article 65(1)(d), (h) and (i) and Article 67 
Article 13 Article 57 
Article 14 Articles 61 to 63 
Article 15 Articles 61 to 63, 70 and 71(2) 
Article 16 Articles 61, 62 and 63 
Article 17 Article 71 
Article 18 Articles 61 and 63 
Article 19 Articles 62 and 63 
Article 20 Article 71 
Article 21 Articles 43(2)(d), 64, 65(1)(d), (h) and (i) and (2) and 67 
Article 22 Articles 65 to 67 
Article 23 Articles 65 to 67 
Article 24 Articles 67 and 71(1) 
Article 25 Articles 65(1)(c), (d)(i), (g), (h) and (i) and 67 
Article 26 Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and 166 
Article 27 Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and 166 31.3.2016 L 84/196 Official Jour nal of the European Union EN     Directive 2003/85/EC This Regulation 
Article 28 Articles 65(1)(c) and (d)(iii) and Article 67 
Article 29 Articles 65(1)(c) and (d)(ii) and 67 
Article 30 Articles 65(1)(c) and (d)(ii) and (iii) and 67 
Article 31 Articles 65(1)(c) and (d)(ii) and 67 
Article 32 Articles 65(1)(c) and (d) and 67 
Article 33 Article 65(1)(c)(d)(ii) and 67 
Article 34 Articles 67, 143(2), 161(2) and 167(1)(b) 
Article 35 Article 71(1) and (2) 
Article 36 Article 68 
Article 37 Articles 65 to 67 
Article 38 Articles 65 to 67 
Article 39 Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and 166 
Article 40 Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and 166 
Article 41 Articles 65(1)(c) and (d)(ii) and 67 
Article 42 Articles 65(1)(c) and (d) and 67 
Article 43 Article 71(1) 
Article 44 Article 68 
Article 45 Articles 64, 67 and 71 
Article 46 Articles 65 and 67 
Article 47 Articles 65(1)(h) and 67 
Article 48 Article 66 
Article 49 Articles 16, 46 and 47 
Article 50 Articles 46, 47 and 69 
Article 51 Articles 47 and 69 
Article 52 Articles 46 and 47 
Article 53 Articles 46 and 47 
Article 54 Articles 47, 65, 67 and 69(2) and(3) 
Article 55 Articles 47, 65, 67, and 69(2) and (3) 
Article 56 Articles 47, 67(c), 68(1)(c) and 69(2) and (3) 
Article 57 Articles 47, 67(c), 68(1)(c) and 69(2) and (3) 
Article 58 Article 68 
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 143(2), 161(2) and 167(1)(b) 
Article 64 Articles 65(1)(c), 67, 69(3) and 131 31.3.2016 L 84/197 Official Jour nal of the European Union EN     Directive 2003/85/EC This Regulation 
Article 65 Article 16 
Article 66 — 
Article 67 — 
Article 68 — 
Article 69 — 
Article 70 Article 16 
Article 71 Articles 54(2) and (3), 58(2), 61(1)(g) and (h), 63(c),  
65(1)(b), 67(c) and 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 Articles 43(2)(d) and 44 
Article 77 Article 44 
Article 78 Article 43(2)(d) 
Article 79 Article 52 
Article 80 Articles 48 and 51 
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 268 
Article 87 — 
Article 88 Article 71(3) 
Article 89 — 
Article 90 — 
Article 91 — 
Article 92 — 
Article 93 — 
Article 94 — 
Article 95 —  31.3.2016 L 84/198 Official Jour nal of the European Union EN     23. Regulation (EC) No 21/2004 
Regulation (EC) No 21/2004 This Regulation 
Article 1 Article 108 
Article 2 Article 4 (par tially) 
Article 3(1) Article 108(3) 
Article 3(2) Article 111 
Article 4(1) and (2) Articles 113(a), 118, 119 and 120 
Article 4(3) Article 118(2)(a) 
Article 4(4) Article 118(2)(e) 
Article 4(5) to (7) Article 118(1)(a) and 2(a) 
Article 4(8) Article 111 
Article 4(9) Article 118(1)(a) and (2)(a) 
Article 5 Articles 102, 106, 107 and 111 
Article 6 Articles 111(b), 113(1)(b) and (2), 118(1)(b)(ii), 119 and 
120(2)(d) 
Article 7 Article 101 
Article 8(1) Articles 109(1)(b) and 118(1)(b) 
Article 8(2) Article 113(1)(c) 
Article 8(3) to (5) Articles 109 and 118(1)(b) 
Article 9 Article 118(1)(a) and 2(a) 
Article 10(1) — 
Article 10(2) Article 120(2)(c) 
Article 11 Articles 11 and 13(2) 
Article 12(1) — 
Article 12(2) Article 268 
Article 12(4) to (7) — 
Article 13 — 
Article 14 — 
Article 15 — 
Article 16 — 
Article 17 —  
24. Directive 2004/68/EC 
Directive 2004/68/EC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3(1) Articles 229(1)(a) and 231 
Article 3(2) Article 232(1) 
Article 4 Article 230(1) 31.3.2016 L 84/199 Official Jour nal of the European Union EN     Directive 2004/68/EC This Regulation 
Article 5 Articles 230(1) and (3) and 231 
Article 6 Articles 234 and 235 
Article 7 Articles 229(2), 234(2)(a), 235 and 238(1)(e) 
Article 8 Articles 234, 237(4)(a) and 239(2)(a) 
Article 9 Articles 234(2), 235 and 237 (4)(a) 
Article 10 Articles 234(2), 235 and 237(4)(a) 
Article 11 Articles 229(1)(d), 237 and 238 
Article 12 — 
Article 13 — 
Article 14 — 
Article 16 — 
Article 17 — 
Article 18 — 
Article 19 — 
Article 20 — 
Article 21 —  
25. Directive 2005/94/EC 
Directive 2005/94/EC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3 Article 10 
Article 4 Articles 26, 28 and 29 
Article 5 Articles 18, 19, 20 and 23 
Article 6 Article 57 
Article 7 Articles 54 to 56 
Article 8 Article 55(2) 
Article 9 Article 59 
Article 10 Articles 55(1)(e) and (f) and 56 
Article 11 Articles 61 and 63 
Article 12 Articles 63 and 71 
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 to 67 
Article 18 Articles 65(1)(a) and (b) and 67 
Article 19 Articles 65 to 67 31.3.2016 L 84/200 Official Jour nal of the European Union EN     Directive 2005/94/EC This Regulation 
Article 20 Articles 65(1)(d)(ii) and 67 
Article 21 Articles 65(1)(c) and (i) and 67 
Article 22 Articles 65(1)(c) and (i) and 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 to 67 
Article 31 Article 68 
Article 32 Articles 65, 67 and 71(2) and (3) 
Article 33 Articles 67 and 71(3) 
Article 34 Article 71 
Article 35 Articles 54 and 61 
Article 36 Articles 61 to 63 
Article 37 Articles 61 to 63 
Article 38 Articles 61, 63, 65 and 67 
Article 39 Articles 61, 63 and 71(2) 
Article 40 Articles 61, 63 and 71 
Article 41 Articles 61, 63 and 71(2) and (3) 
Article 42 Articles 62 and 63(e) 
Article 43 Article 64 
Article 44 Articles 65 and 67 
Article 45 Article 68 
Article 46 Articles 64(4), 67 and 71(2) and (3) 
Article 47 Articles 54, 55, 61, 63 and 71 
Article 48 Article 68(1)(b) and (2)(a) 
Article 49 Articles 61(3) and 68 
Article 50 Articles 16, 54(2)(b) and (c) and (3), 58(2), 61(1)(g)  
and (h), 63(c), 65(1)(b), 67(c), 68(1)(c) and 2(b) 
Article 51 — 
Article 52 Articles 46 and 47 
Article 53 Article 69 
Article 54 Articles 47, 65(1)(e), 67, 69 and 71(3) 
Article 55 Articles 47, 65(1)(e), 67, 69 and 71(3) 
Article 56 Articles 46 and 47 
Article 57 Article 47 31.3.2016 L 84/201 Official Jour nal of the European Union EN     Directive 2005/94/EC This Regulation 
Article 58 Articles 48 to 50 
Article 59 Article 52 
Article 60 — 
Article 61 Article 268 
Article 62 Articles 43 and 44 
Article 63 — 
Article 64 — 
Article 65 — 
Article 66 — 
Article 67 — 
Article 68 — 
Article 69 —  
26. Directive 2006/88/EC 
Directive 2006/88/EC This Regulation 
Article 1 — 
Article 2 Articles 2 and 3(2) 
Article 3 Article 4 (par tially) 
Article 4(1) Articles 172, 173, 176 and 177 
Article 4(2) Article 179 
Article 4(3) Article 185(2) 
Article 4(4) Articles 172, 173, 174 and 175 
Article 4(5) — 
Article 5 Article 181 
Article 6 Article 185 
Article 7 — 
Article 8 Articles 186, 187, 188 and 189 
Article 9 Article 181(1)(a)(i), (2) and (3) 
Article 10 Article 181(1)(a)(ii), (2) and (3) 
Article 11 Articles 191 and 204 
Article 12 Article 191 
Article 13 Article 192 
Article 14(1) and (2) Articles 208 and 211 
Article 14(3) and (4) Articles 219 and 220 
Article 15(1) and (2) Articles 196 and 197 
Article 15(3) Article 193 
Article 15(4) Articles 196, 197 and 199 
Article 16 Article 197 
Article 17 Article 197 31.3.2016 L 84/202 Official Jour nal of the European Union EN     Directive 2006/88/EC This Regulation 
Article 18 Articles 201 and 202 
Article 19 Articles 201 and 202 
Article 20 Article 200 
Article 21 Articles 200, 203, 205 and 226 
Article 22 Article 229(1)(a) 
Article 23 Articles 230 and 231 
Article 24 Articles 229(1)(d) and 237 
Article 25 Articles 234, 237 and 238 
Article 26 Article 18 
Article 27 Articles 19 and 20 
Article 28 Articles 53 to 55 and 72 to 74 
Article 29 Articles 57 and 77(1)(b) 
Article 30 Articles 59 and 78 
Article 31 — 
Article 32 Articles 60, 61, 62 and 64 
Article 33 Articles 65 to 67 
Article 34 Articles 61(1)(b)and (c) and Article 63 
Article 35 Articles 61(3) and 63 
Article 36 — 
Article 37 Article 68 
Article 38 Articles 77, 79 and 80(3) 
Article 39 Articles 79 and 80 
Article 40 Article 81 
Article 41 Article 257(1)(b) and (c) 
Article 42 Article 71(3) 
Article 43 Article 226 
Article 44 Articles 27, 28, 31 and 32 
Article 45 Article 33 
Article 46 Article 31(2) 
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 — 31.3.2016 L 84/203 Official Jour nal of the European Union EN     Directive 2006/88/EC This Regulation 
Article 55 — 
Article 56 — 
Article 57(a) — 
Article 57(b) Articles 54(2)(c) and (3), 58, 61(1)(g) and (h), 63(c),  
65(1)(b) and 67(c) 
Article 57(c) — 
Article 58 — 
Article 59 Articles 38 and 185 (par tially) 
Article 60 Article 268 
Article 61 — 
Article 62 — 
Article 63 — 
Article 64 — 
Article 65 — 
Article 66 — 
Article 67 —  
27. Directive 2008/71/EC 
Directive 2008/71/EC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3(1) Articles 101 and 111 
Article 3(2) Articles 118(2) and 119 
Article 4(1) Articles 102, 107 and 119 
Article 4(2) Article 102(3) 
Article 5(1) Articles 115(a), 118(1)(a) and (2)(a) and 120 
Article 5(2) Article 118(1)(a) and (2)(a) 
Article 6(1) Articles 115(a), 118(1)(a) and (2)(a) and 120 
Article 6(2) — 
Article 7 Article 109(1)(c) and (2) 
Article 8 Article 118(2)(e) 
Article 9 Article 268 
Article 10 — 
Article 11 — 
Article 12 — 
Article 13 —  31.3.2016 L 84/204 Official Jour nal of the European Union EN     28. Directive 2009/156/EC 
Directive 2009/156/EC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3 Articles 126 and 139 
Article 4(1) Articles 130 and 149(3) 
Article 4(2) Articles 130 and 131 
Article 4(3) Article 128 
Article 4(4) Articles 114, 118 and 120 
Article 4(5) Articles 126(1)(b), 130 and 131 
Article 4(6) Articles 31 to 35 
Article 5 Articles 130 and 131 
Article 6 Articles 130, 131 and 144(1)(b) 
Article 7(1) Articles 126(2) and 133 
Article 7(2) Articles 131 and 132 
Article 7(3) Article 130, 131 and 132 
Article 8 Articles 114(1)(c), 118, 120 and 143 to 146 
Article 9 Articles 257 to 259 (par tially) 
Article 10 — 
Article 11 — 
Article 12(1),(2) and (3) Articles 229(1)(a), 230 and 231 
Article 12(4) Article 234 
Article 12(5) — 
Article 13 Articles 234 and 235 
Article 14 Article 234 
Article 15 Article 234 
Article 16 Articles 234, 235 and 237 
Article 17 Article 234 
Article 18 — 
Article 19(a) to (c) Articles 234 and 239 
Article 19(d) — 
Article 20 — 
Article 21 — 
Article 22 — 
Article 23 — 
Article 24 —  31.3.2016 L 84/205 Official Jour nal of the European Union EN     29. Directive 2009/158/EC 
Directive 2009/158/EC This Regulation 
Article 1 — 
Article 2 Article 4 (par tially) 
Article 3 — 
Article 4 — 
Article 5 Articles 126, 130, 131, 159 and 160 
Article 6 Articles 124, 126 and 159 
Article 7 Article 101 
Article 8 Articles 159 and 160 
Article 9 Articles 130 and 131 
Article 10 Articles 130, 131 and 149(3) and (4) 
Article 11 Articles 130, 131 and 149(3) and (4) 
Article 12 Articles 130 and 131 
Article 13 Articles 131 and 273 
Article 14 Article 131 
Article 15(1)(a) Articles 159 and 160 
Article 15(1)(b) to (d) Articles 130 and 131 
Article 15(2) Articles 31 to 35 and 36(3) 
Article 15(3) Article 42 
Article 16 Articles 31 to 35 
Article 17 Articles 36, 39 and 40 
Article 18 Articles 117, 118(2)(e), 122(2), 124, 125, 126(1)(a) 
and (2), 132 and 157(3) 
Article 19 Articles 130 and 131 
Article 20 Articles 143(1)(a), 144, 145, 149, 161 and 162 
Article 21 Articles 139 and 144(1)(a) and (b) 
Article 22 — 
Article 23 Articles 229(1)(a), 230 and 231 
Article 24 Article 234 
Article 25 Article 234 
Article 26 Article 237 
Article 27 — 
Article 28 Articles 234, 235 and 236 
Article 29 Articles 234, 235 and 239 
Article 30 Article 234 
Article 31 Articles 257 to 259 31.3.2016 L 84/206 Official Jour nal of the European Union EN     Directive 2009/158/EC This Regulation 
Article 32 — 
Article 33 — 
Article 34 — 
Article 35 — 
Article 36 — 
Article 37 — 
Article 38 —  
30. Regulation (EU) No 576/2013 
Regulation (EU) No 576/2013 This Regulation 
Article 1 — 
Article 2 Articles 3(5) and (6) and 244 
Article 3 Article 4 (par tially) 
Article 4 Article 245(1) 
Article 5(1) and (2) Article 246(1) and (2) 
Article 5(3) — 
Article 5(4) Articles 3(4) to (6) 
Article 5(5) Article 246(3) 
Article 5(6) — 
Article 6 Articles 247 and 252(1)(a) and (b) 
Article 7 Article 252(1)(b) and (4)(d) 
Article 8(1) and (3) Article 252(1)(b) and (d) 
Article 8(2) Article 253(1)(b) 
Article 9 Articles 248 and 252(1)(a) and (b) 
Article 10 Articles 249 and 252(1)(a) and (b) 
Article 11 Article 252(1)(b) and (4)(d) 
Article 12 Article 252(1)(b) and (4)(d) 
Article 13 Articles 252(4)(d) and 253(1)(d) 
Article 14 Article 250 and 252(1)(a) and (b) 
Article 15 Articles 252(4) and 253(1)(d) 
Article 16 Article 251 
Article 17 Articles 247(a) and 252(1)(a) 
Article 18 Articles 252(1)(a)(ii) and 14(1)(c)(iv) and (2) 
Article 19 Article 252(1)(a), (2), (3) and(4)(a),(b) and(c) 
Article 20 Article 253(1)(c) 
Article 21 Articles 254(a) and 255(1) and (2)(b) 
Article 22 Article 254(d) 31.3.2016 L 84/207 Official Jour nal of the European Union EN     Regulation (EU) No 576/2013 This Regulation 
Article 23 Article 254(b) 
Article 24 Article 254(c) 
Article 25 Articles 254(a) and 255(1) 
Article 26 Article 254(d) 
Article 27 Article 254(c) 
Article 28 Articles 254(a) and 255(2)(a) 
Article 29 Article 254(d) 
Article 30 Articles 254(a) and 255(2)(a) 
Article 31 Article 254(d) 
Article 32 Article 252(4)(e) 
Article 33 — 
Article 34 — 
Article 35 — 
Article 36 Articles 257 to 262 
Article 37 Article 256 
Article 38 — 
Article 39 — 
Article 40 — 
Article 41 — 
Article 42 Article 268 
Article 43 — 
Article 44 — 
Article 45 —   31.3.2016 L 84/208 Official Jour nal of the European Union EN