EUR-Lex Access to European Union law

Back to EUR-Lex homepage

This document is an excerpt from the EUR-Lex website

Document 02016R0429-20191214

Consolidated text: Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law) (Text with EEA relevance)Text with EEA relevance

ELI: http://data.europa.eu/eli/reg/2016/429/2019-12-14

02016R0429 — EN — 14.12.2019 — 001.004


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

REGULATION (EU) 2016/429 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 9 March 2016

on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’)

(Text with EEA relevance)

(OJ L 084 31.3.2016, p. 1)

Amended by:

 

 

Official Journal

  No

page

date

►M1

REGULATION (EU) 2017/625 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2017

  L 95

1

7.4.2017


Corrected by:

►C1

Corrigendum, OJ L 057, 3.3.2017, p.  65 (2016/429)

►C2

Corrigendum, OJ L 137, 24.5.2017, p.  40 (2017/625)

►C3

Corrigendum, OJ L 048, 11.2.2021, p.  3 (2016/429)




▼B

REGULATION (EU) 2016/429 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 9 March 2016

on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’)

(Text with EEA relevance)



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 categorisation of diseases of Union concern and for the establishment of responsibilities for animal health (Part I: Articles 1 to 17);

(b) 

the early detection, notification and reporting of diseases, surveillance, eradication programmes and disease–free status (Part II: Articles 18 to 42);

(c) 

disease awareness, preparedness and control (Part III: Articles 43 to 83);

(d) 

the registration and approval of establishments and transporters, movements and traceability of animals, germinal products and products of animal origin within the Union (Part IV: Articles 84 to 228; and Part VI: Articles 244 to 248 and 252 to 256);

(e) 

the entry of animals, germinal products, and products of animal origin into the Union and the export 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 country or territory, (Part VI: Articles 244 to 256);

(g) 

the emergency measures to be taken in the event of a disease emergency situation (Part VII: Articles 257 to 262).

2.  

The rules referred to in paragraph 1:

(a) 

aim to ensure:

(i) 

improved animal health to support 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 environment of:

— 
certain diseases;
— 
the measures taken to prevent and control diseases;
(b) 

take into account:

(i) 

the relationship between animal health and:

— 
public health;
— 
the environment, including biodiversity and valuable genetic resources, as well as the impact of climate change;
— 
food and feed safety;
— 
animal welfare, including the sparing of any avoidable pain, distress or suffering;
— 
antimicrobial resistance;
— 
food security;
(ii) 

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

(iii) 

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

2.  

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

(a) 

Decision No 1082/2013/EU;

(b) 

Regulation (EC) No 999/2001;

(c) 

Directive 2003/99/EC;

(d) 

Regulation (EC) No 2160/2003.

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 terrestrial animals but which may transmit diseases affecting terrestrial animals;

(b) 

germinal products from terrestrial animals;

(c) 

products of animal origin from terrestrial animals.

2.  

Title II of Part IV (Articles 172 to 226) shall apply to:

(a) 

aquatic animals, and animals which 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 referred to in point (a).

4.  
Parts IV and V shall not apply to non–commercial movements of pet animals as referred 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 delegated acts in accordance with Article 264 concerning the adaptations which are necessary 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 keepers.

6.  
Part VI shall only apply to non–commercial movements of pet animals that comply with the requirements laid down in Articles 245 and 246 as regards the maximum number of animals that may accompany their owner and the maximum number of days elapsing between the movement of the owner and the movement of the animal.

Article 4

Definitions

For the purposes of this Regulation, the following definitions apply:

(1) 

‘animals’ means vertebrate and invertebrate animals;

(2) 

‘terrestrial animals’ means birds, terrestrial mammals, bees and bumble bees;

(3) 

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

(a) 

fish belonging to the superclass Agnatha and to the classes Chondrichthyes, Sarcopterygii and Actinopterygii;

(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;

(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 property of one or more natural or legal persons throughout the rearing or culture stages, up to and including harvesting, excluding the harvesting or catching for the purposes of human consumption of wild aquatic animals which are subsequently temporarily kept while awaiting 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) 

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

(a) 

the production of:

(i) 

meat;

(ii) 

eggs for consumption;

(iii) 

other products;

(b) 

restocking supplies of game birds;

(c) 

the purpose of breeding of birds used for the types of production referred to in points (a) and (b);

(10) 

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

(11) 

‘pet animal’ means 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, keeping a pet animal;

(13) 

‘pet owner’ means a natural person indicated as the owner in the identification document referred 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 accompanying 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 concerned; and

(b) 

is part of the movement of the pet owner:

(i) 

either under his direct responsibility; or

(ii) 

under the responsibility of an authorised person, in cases where the pet animal is physically separated from the pet owner;

(15) 

‘authorised person’ means any natural person who has authorisation 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 occurrence of infections and infestations in animals, with or without clinical or pathological manifestations, caused by one or more disease agents;

(17) 

‘disease agent’ means a pathogen transmissible to animals or to humans which is capable of causing a disease in animals;

(18) 

‘listed diseases’ means diseases listed in accordance with Article 5(1);

(19) 

‘disease profile’ means the criteria of a disease referred to in point (a) of Article 7;

(20) 

‘listed 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 which 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 potential to have an adverse effect on the health of humans or animals;

(22) 

‘risk’ means the likelihood of the occurrence and the likely magnitude of the biological and economic consequences of an adverse effect on animal or public health;

(23) 

‘biosecurity’ means the sum of management and physical measures designed to reduce the risk of the introduction, development and spread of diseases to, from and within:

(a) 

an animal population, or

(b) 

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

(24) 

‘operator’ means any natural or legal person having animals or products under his responsibility, including for a limited duration of time, but excluding pet keepers and veterinarians;

(25) 

‘transporter’ means an operator transporting animals on his own account or on account of a third party;

(26) 

‘animal professional’ means a natural or legal person having an occupational relationship with animals or products, other than operators or veterinarians;

(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 temporary or permanent basis, except for:

(a) 

households where pet animals are kept;

(b) 

veterinary practices or clinics;

(28) 

‘germinal products’ means:

(a) 

semen, oocytes and embryos intended for artificial reproduction;

(b) 

hatching eggs;

(29) 

‘products of animal origin’ means:

(a) 

food of animal origin, including honey and blood;

(b) 

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

(c) 

animals other than those referred to in 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 consumption, excluding germinal products;

(31) 

‘derived products’ means products obtained from one or more treatments, transformations 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;

▼M1

(33) 

‘official control’ means any form of control performed in accordance with Regulation ►C2  (EU) 2017/625 ◄ of the European Parliament and of the Council ( 1 );

▼B

(34) 

‘health status’ means the disease status as regards the listed 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 compartment;

(v) 

a Member State;

(vi) 

a third country or territory;

(35) 

‘zone’ means:

(a) 

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

(b) 

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

(i) 

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

(ii) 

more than one water catchment;

(iii) 

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

(iv) 

part of a coastal area with a precise geographical delimitation;

(v) 

an estuary with a precise geographical delimitation;

(36) 

‘water catchment’ means an area or basin of land bounded by natural features such as hills or mountains, into which all run–off water flows;

(37) 

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

(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 ensuring that there is no spread of one or more specified diseases while the animals in isolation are undergoing observation for a specified length of time and, if appropriate, 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 officially confirmed occurrence of a listed disease or an emerging disease in one or more animals in an establishment or other place where animals are kept or located;

(41) 

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

(42) 

‘protection 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 which 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) 

‘hatching eggs’ means eggs, laid by poultry or captive birds, intended for incubation;

(45) 

‘ungulates’ means the animals listed in Annex III;

(46) 

‘germinal product establishment’ means:

(a) 

in relation to semen, an establishment where semen is collected, produced, processed or stored;

(b) 

in relation to oocytes and embryos, a group of professionals or structure supervised by a team veterinarian competent to perform the collection, production, processing and storage of oocytes and embryos;

(c) 

in relation to hatching eggs, a hatchery;

(47) 

‘hatchery’ means an establishment which collects, stores, incubates and hatches eggs for the supply of:

(a) 

hatching eggs;

(b) 

day–old chicks or hatchlings of other species;

(48) 

‘confined establishment’ means any permanent, geographically limited establishment, created on a voluntary basis and approved for the purpose of movements, where the animals are:

(a) 

kept or bred for the purposes of exhibitions, education, the conservation of species or research;

(b) 

confined and separated from the surrounding environment; and

(c) 

subject to animal health surveillance and biosecurity measures;

(49) 

‘assembly operation’ means the assembling of kept terrestrial animals from more than one establishment for a period shorter than the required residency period for the species of animals concerned;

(50) 

‘residency period’ means the minimum period necessary in order to ensure that an animal which has been introduced into an establishment is not of a lower health status than that of the animals in that establishment;

▼M1

(51) 

‘traces’ means a system component integrated into the IMSOC as referred to in Articles 131 to 136 of Regulation ►C2  (EU) 2017/625 ◄ ;

▼B

(52) 

‘disease control aquatic food establishment’ means a food business approved in accordance with Article 179;

▼M1

(53) 

‘official veterinarian’ means an official veterinarian as defined in Article 3(32) of Regulation ►C2  (EU) 2017/625 ◄ ;

▼B

(54) 

‘official veterinarian in a third country or territory’ means a veterinarian in a third country or territory corresponding to an official veterinarian as referred to in point (53);

▼M1

(55) 

‘competent authority’ means the central veterinary authority of a Member State responsible for the organisation of official controls and any other official activities in accordance with this Regulation and Regulation ►C2  (EU) 2017/625 ◄ , or any other authority to which that responsibility has been delegated;

▼B

(56) 

‘competent authority of a third country or territory’ means the authority in a third country or territory corresponding to the competent authorities referred to in point (55).



CHAPTER 2

Listed diseases and emerging diseases and listed species

Article 5

Listing of diseases

1.  

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

(a) 

the following listed diseases:

(i) 

foot and mouth disease;

(ii) 

classical swine fever;

(iii) 

African swine fever;

(iv) 

highly pathogenic avian influenza;

(v) 

African horse sickness; and

(b) 

the listed diseases set out in the list in Annex II.

2.  
The Commission shall adopt delegated acts in accordance with Article 264 concerning 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 susceptible to the disease or vectors and reservoirs 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 character;

(iv) 

diagnostic tools are available for the disease; and

(v) 

risk-mitigating measures and, where relevant, surveillance of the disease are effective and proportionate 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 significant negative effects in the Union on animal health, or poses or could pose a significant risk to public health due to its zoonotic character;

(ii) 

the disease agent has developed resistance to treatments which poses a significant danger 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 potential to generate a crisis or the disease agent could be used for the purpose of bioterrorism; or

(v) 

the disease has or could have a significant negative impact on the environment, including biodiversity, of the Union.

4.  
The Commission shall adopt delegated acts in accordance with Article 264 concerning the removal of a disease from the list referred 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.
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 change of an existing disease agent;

(b) 

is a known 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 necessary measures regarding an emerging disease which fulfils the criteria set out in paragraph 2 of this Article. Those implementing acts shall be adopted 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 having a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).
5.  
Any obligation on operators in respect of an emerging disease, as set out in this Regulation, shall only apply if the Commission has adopted 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 parameters in order to determine whether a disease meets the conditions requiring it to be listed in accordance with Article 5(2):

(a) 

the disease profile, which shall comprise the following:

(i) 

the animal species concerned by the disease;

(ii) 

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

(iii) 

the zoonotic character of the disease;

(iv) 

the 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 distribution of the disease in the Union, and, where the disease is not present in the Union, the risk of its introduction into the Union;

(viii) 

the existence of diagnostic and disease control tools;

(b) 

the impact of the disease on:

(i) 

agricultural and aquaculture production and other parts of the economy, as regards:

— 
the level of presence of the disease in the Union;
— 
the loss of production due to the disease;
— 
other losses;
(ii) 

human health, as regards:

— 
transmissibility between animals and humans;
— 
transmissibility between humans;
— 
the severity of human forms of the disease;
— 
the availability of effective prevention or medical treatment in humans;
(iii) 

animal welfare;

(iv) 

biodiversity and the environment;

(c) 

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

(d) 

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

(i) 

diagnostic tools and capacities;

(ii) 

vaccination;

(iii) 

medical treatments;

(iv) 

biosecurity measures;

(v) 

restrictions on the movement of animals and products;

(vi) 

killing of animals;

(vii) 

disposal of carcasses and other relevant animal by–products;

(e) 

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

(i) 

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

(ii) 

their societal acceptance;

(iii) 

the welfare of affected subpopulations of kept and wild animals;

(iv) 

the environment and biodiversity.

Article 8

Listing of species

1.  
The disease-specific rules for listed diseases provided for in this Regulation and the rules adopted pursuant to this Regulation shall apply to listed species.
2.  
The Commission shall, by means of implementing acts, establish a list of species as referred to in paragraph 1 of this Article that fulfil the criteria set out in paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

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

(a) 

the susceptibility of the animal population at risk;

(b) 

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

(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 specific listed disease because:

(a) 

they are susceptible to a specific listed disease or scientific evidence indicates that such susceptibility is likely; or

(b) 

they are vector species or reservoirs for that disease, or scientific evidence indicates that such role is likely.

4.  

The Commission shall, by means of implementing acts, remove animal species or groups of animal species from the list when:

(a) 

the relevant listed disease in relation to which the animal species or group of animal species concerned has been listed has been removed from the list of diseases; or

(b) 

scientific evidence indicates that the species or group of species concerned no longer fulfils the criteria set out in paragraph 3.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 9

Disease prevention and control rules to be applied to different categories of listed diseases

1.  

Disease prevention and control rules shall apply to listed diseases as follows:

(a) 

As regards listed diseases that do not normally occur in the Union and for which immediate eradication measures must be taken as soon as they are detected, the following rules shall apply, as relevant:

(i) 

the rules for disease awareness and preparedness provided for in Title I of Part III (Articles 43 to 52);

(ii) 

the disease control measures provided for in Chapter 1 of Title II of Part III (Articles 53 to 71); and

(iii) 

the rules for compartmentalisation provided for in Article 37(1).

For those listed diseases, the measures referred to in point (b), as appropriate, as well as points (d) and (e), shall also apply, as relevant.

(b) 

As regards listed diseases which 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 compulsory eradication programmes provided for in Article 31(1);

(ii) 

the rules for disease–free Member States and zones provided for in Article 36;

(iii) 

the rules for compartmentalisation 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 referred to in points (d) and (e) shall also apply, as relevant.

(c) 

As regards listed diseases which 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 listed disease concerned, 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 States and zones provided for in Article 36;

(iii) 

the rules for compartmentalisation 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 referred to in points (d) and (e) shall also apply, as relevant.

(d) 

As regards listed diseases for which measures are needed to prevent them from spreading on account of their entry 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 Chapters 3 to 6 of Title I (Articles 124 to 169), Chapters 2 and 3 of Title II of Part IV (Articles 191 to 225) and Chapters 2 and 3 of Part VI (Articles 247 to 251); and

(ii) 

the rules for entry into the Union and export from the Union provided for in Part V (Articles 229 to 243).

The listed diseases referred to in points (a), (b) and (c) shall also be considered as listed diseases under this point, as well as those referred to in point (e), where the risk posed by the disease in question can be effectively and proportionately mitigated by measures concerning 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 notification and reporting provided for in Chapter 1 of Part II (Articles 18 to 23); and

(ii) 

the rules for surveillance provided for in Chapter 2 of Part II (Articles 24 to 30).

The listed diseases referred to in points (a), (b) and (c) shall also be considered as listed diseases under this point.

2.  
The Commission shall, by means of implementing acts, determine the application of the disease prevention and control rules referred 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 significant scientific data.

Those implementing acts shall be adopted 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 referred to in paragraph 2 to the respective listed diseases when the disease in question no longer fulfils the criteria laid down in the relevant Section of Annex IV, also in the light of newly available significant scientific data.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

4.  
On duly justified imperative grounds of urgency relating to a listed disease representing an emerging risk having a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).



CHAPTER 3

Responsibilities for animal health



Section 1

Operators, animal professionals and pet keepers

Article 10

Responsibilities for animal health and biosecurity measures

1.  

Operators shall:

(a) 

as regards kept animals and products under their responsibility, be responsible for:

(i) 

the health of kept animals;

(ii) 

prudent and responsible use of veterinary medicines, without prejudice to the role and responsibility of veterinarians,

(iii) 

minimising the risk of the spread of diseases;

(iv) 

good animal husbandry;

(b) 

where appropriate, take such biosecurity measures regarding kept animals, and products under their responsibility, as are appropriate for:

(i) 

the species and categories 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 appropriate, take biosecurity measures regarding wild animals.

2.  
Animal professionals shall take action to minimise the risk of the spread of diseases in the context of their occupational relationship with animals and products.
3.  
Point (a) of paragraph 1 shall also apply to pet keepers.
4.  

The biosecurity measures referred to in point (b) of paragraph 1 shall be implemented, as appropriate, through:

(a) 

physical protection measures, which may include:

(i) 

enclosing, fencing, roofing, netting, as appropriate;

(ii) 

cleaning, disinfection and control of insects and rodents;

(iii) 

in the case of aquatic animals, where appropriate:

— 
measures concerning the water supply and discharge;
— 
natural or artificial barriers to surrounding water courses that prevent aquatic animals from entering or leaving the establishment concerned, including measures against flooding or infiltration of water from surrounding water courses;
(b) 

management 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.  
Operators, animal professionals and pet keepers shall cooperate with the competent authority and veterinarians 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 necessary for the uniform application of this Article.

Such implementing acts shall reflect the matters referred to in point (b) of paragraph 1.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 11

Knowledge of animal health

1.  

Operators and animal professionals shall have adequate knowledge of:

(a) 

animal diseases, including those that are transmissible to humans;

(b) 

biosecurity principles;

(c) 

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

(d) 

good practice of animal husbandry for the animal species under their care;

(e) 

resistance to treatments, including antimicrobial resistance, and its implications.

2.  

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

(a) 

the species and categories of kept animals or products under the responsibility of the operators and animal professionals concerned and the nature of their occupational relationship with those animals or products;

(b) 

the type of production;

(c) 

the tasks performed.

3.  

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

(a) 

professional experience or training;

(b) 

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

(c) 

formal education;

(d) 

other experience or other training which results in the same level of knowledge as that covered by points (a), (b) or (c).

4.  
Operators selling or otherwise transferring the ownership of future pet animals shall provide basic information to the future pet keeper, regarding the matters referred to in paragraph 1, as relevant for the pet animal in question.



Section 2

Veterinarians and aquatic animal health professionals

Article 12

Responsibilities of veterinarians and aquatic animal health professionals

1.  

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

(a) 

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

(b) 

take action to ensure the early detection of diseases by carrying out proper diagnosis and differential diagnosis to rule out or confirm a disease;

(c) 

play an active role in:

(i) 

raising animal health awareness, and awareness of the interaction between animal health, animal welfare and human health;

(ii) 

disease prevention;

(iii) 

the early detection of, and rapid response to, diseases.

(iv) 

raising awareness of resistance to treatments, including antimicrobial resistance, and its implications;

(d) 

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

2.  
Aquatic animal health professionals may undertake activities assigned to veterinarians under this Regulation in relation to aquatic animals provided that they are authorised to do so by the Member State concerned under national law. In that event, paragraph 1 shall apply to those aquatic animal health professionals.
3.  
Veterinarians and aquatic animal health professionals shall maintain and develop their professional capacities related to their areas of activities which fall within the scope of this Regulation.



Section 3

Member States

Article 13

Member States' responsibilities

1.  

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

(a) 

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

(b) 

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

(c) 

sufficiently trained veterinarians involved in performing the activities referred to in Article 12.

2.  
Member States shall encourage operators and animal professionals to acquire, maintain and develop the adequate knowledge of animal health provided for in Article 11 through relevant programmes in agricultural or aquaculture sectors or formal education.

Article 14

Delegation by a competent authority of official activities

1.  

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

(a) 

practical application of measures under the eradication programmes provided for in Article 32;

(b) 

supporting the competent authority in carrying out surveillance as provided for in Article 26 or in relation to surveillance programmes as provided for in Article 28;

(c) 

activities related to:

(i) 

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

— 
sampling activities and implementation of investigations and epidemiological enquiries within the framework of Article 54, points (b) to (g) of Article 55(1), and Articles 57, 73, 74, 79 and 80 in the event of the suspected presence of a disease, and any implementing and delegated acts adopted pursuant to those Articles;
— 
carrying out activities relating to disease control measures in the event of an outbreak of disease, ►C1  as regards activities listed in Article 61, points (a), (b), (e), (f) and (i) of Article 65(1), Article 70(1), Articles 79, 80, 81 and 82, and ◄ any implementing and delegated acts adopted pursuant to those Articles;
— 
carrying out emergency vaccination in accordance with Article 69;
(ii) 

registration, approval, 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 authorised to perform activities referred to in points (a), (b) and (c)(i), (ii) and (iv) of paragraph 1 for specifically identified tasks for which those persons have sufficient specific knowledge. 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 empowered to adopt delegated acts in accordance with Article 264 concerning other activities which may be delegated to veterinarians in addition to those provided for in paragraph 1, and, as appropriate, to prescribe the necessary circumstances and conditions for such delegation.

The Commission shall take account of the nature of those activities and of relevant international standards when adopting those delegated acts.

Article 15

Public information

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 competent authority shall take appropriate steps to inform the public of the nature of the risk and the measures which are taken or about to be taken to prevent or control that risk, taking into account the nature, seriousness and extent of that risk and the public interest in being informed.



Section 4

Laboratories, facilities and other natural and legal persons handling disease agents, vaccines and other biological products

Article 16

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

1.  

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

(a) 

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

(b) 

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

2.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the safety measures for the prevention and control of listed and emerging diseases as regards laboratories, facilities and other natural or legal persons handling the disease agents, vaccines and other biological products in relation to:

(a) 

biosecurity, biosafety and bio–containment measures;

(b) 

movement requirements for disease agents, vaccines and other biological products.

Article 17

Animal health laboratories

1.  
Official laboratories for animal health, consisting of Union reference laboratories, national reference laboratories and official animal health laboratories, shall, in fulfilling their tasks and responsibilities, cooperate within a network of Union animal health laboratories.
2.  
The laboratories referred to in paragraph 1 shall cooperate under the coordination of the Union reference laboratories, to ensure that the surveillance, notification and reporting of diseases, eradication programmes, the definition of disease–free status, and the movements of animals and products within the Union, their entry into the Union and exports to third countries or territories provided for in this Regulation, are based on state–of–the–art, solid and reliable laboratory analyses, tests and diagnoses.
3.  
The results and reports provided by the official laboratories shall be subject to the principles of professional secrecy and confidentiality and the duty of notification to the competent authority which designated them, irrespective of the natural or legal person who requested 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 competent authority of the Member State from which the samples originated:

(a) 

immediately of any results indicating the suspicion or detection of a listed disease as referred to in point (a) of Article 9(1);

(b) 

without undue delay of any results indicating the suspicion or detection 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).



PART II

DISEASE NOTIFICATION AND REPORTING, SURVEILLANCE, ERADICATION PROGRAMMES, DISEASE–FREE STATUS



CHAPTER 1

Disease notification and reporting

Article 18

Notification within Member States

1.  

Member States shall ensure that operators and other relevant natural or legal persons:

(a) 

immediately notify the competent authority where there are any reasons to suspect the presence in animals of a listed disease as referred to in point (a) of Article 9(1), or where the presence of such a disease is detected in animals;

(b) 

as soon as practicable notify the competent authority 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 detected in animals;

(c) 

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

2.  
Member States may decide that the notifications provided for in point (c) of paragraph 1 may be directed to the competent authority.
3.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

criteria to determine whether the circumstances requiring notification described 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 notification

1.  
Member States shall immediately notify the Commission and the other Member States of any outbreaks of listed diseases as referred to in point (e) of Article 9(1) for which an immediate notification is required in order to ensure the timely implementation of necessary risk management measures, taking into account the disease profile.
2.  

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

(a) 

the disease agent and, where relevant, the subtype;

(b) 

the relevant dates, in particular those of the suspicion and the confirmation of the outbreak;

(c) 

the type and location of the outbreak;

(d) 

any related outbreaks;

(e) 

the animals involved in the outbreak;

(f) 

any disease control measures taken in relation to the outbreak;

(g) 

the possible or known origin of the listed disease;

(h) 

the diagnostic methods used.

Article 20

Union reporting

1.  

Member States shall report to the Commission and to the other Member States the information on listed diseases referred to in in point (e) of Article 9(1) for which:

(a) 

immediate notification of an outbreak is not required under Article 19(1);

(b) 

immediate notification of an outbreak is required under Article 19(1), but additional information is required to be reported to the Commission and the other Member States on:

(i) 

surveillance in accordance with the rules laid down in an implementing act adopted in accordance with Article 30;

(ii) 

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

2.  

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

(a) 

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

(b) 

the results of surveillance when required in accordance with rules adopted in accordance with 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 adopted 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 adopted in accordance with Article 35.

3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning provisions supplementing the requirements of paragraph 2 and reporting on other matters concerning surveillance and eradication programmes where necessary in order to ensure an efficient application of the disease prevention rules and control rules laid down in this Regulation.

Article 21

Notification and reporting regions

The Member States shall establish notification and reporting regions for the purpose of the notification and reporting provided for in Articles 19 and 20.

Article 22

Computerised information system for Union notification and Union reporting of diseases

The Commission shall set up and manage a computerised information system for the operation of the mechanisms and tools for the notification and reporting requirements provided for in Articles 19, 20 and 21.

Article 23

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

The Commission shall, by means of implementing acts, lay down rules for the notification and reporting requirements and the computerised information system provided for in Articles 19 to 22 with respect to:

(a) 

those listed diseases referred to in point (e) of Article 9(1) which are to be subject to immediate notification by the Member States as well as the necessary measures relating to the notification, in accordance with Article 19;

(b) 

the information to be provided by the Member States in the reporting provided for in Article 20;

(c) 

procedures for the establishment and use of the computerised 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 computerised information system provided for in Article 22;

(e) 

the deadlines and frequencies of the notification and reporting provided for in Articles 19 and 20, which shall be done at times and frequencies which ensure transparency and the timely application of the necessary risk management measures, based on the disease profile and the type of outbreak.

(f) 

the listing of notification and reporting regions provided for in Article 21.

Those implementing acts shall be adopted 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) 

observe the health and behaviour of animals under their responsibility;

(b) 

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

(c) 

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

Article 25

Animal health visits

1.  

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

(a) 

the type of establishment;

(b) 

the species and categories of kept animals on the establishment;

(c) 

the epidemiological situation in the zone or region as regards listed and emerging diseases to which the animals in the establishment are susceptible;

(d) 

any other relevant surveillance, or official controls to which the kept animals and type of establishment are subject.

Such animal health visits shall take place at frequencies that are proportionate to the risks posed by the establishment concerned.

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 concerned on biosecurity and other animal health matters, as relevant for the type of establishment and the species and categories of kept animals on the establishment.

(b) 

the detection of, and information on, signs indicative of the occurrence of listed diseases or emerging diseases;

3.  
The Commission may, by means of implementing acts, lay down minimum requirements necessary for the uniform application of this Article.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 26

The competent authority's surveillance obligation

1.  
The competent authority shall conduct surveillance to detect the presence of listed diseases as referred to in point (e) of Article 9(1) and relevant emerging diseases.
2.  
The surveillance shall be designed in such a way as to ensure the timely detection of the presence of the listed diseases referred 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 competent authority shall, whenever possible and appropriate, make use of the results of the surveillance conducted by operators and the information obtained through animal health visits in accordance with Articles 24 and 25, respectively.
4.  
The competent authority shall ensure that surveillance meets the requirements provided for in Article 27 and in any rules adopted pursuant to point (a) of Article 29.
5.  
The competent authority shall ensure that the information obtained through the surveillance provided for in paragraph 1 is collected and used in an effective and efficient manner.

Article 27

Methodology, frequency and intensity of surveillance

The design, means, diagnostic methods, frequency, intensity, targeted animal population, and sampling patterns of the surveillance provided for in Article 26 shall be appropriate and proportionate to the objectives of the surveillance, taking into account:

(a) 

the disease profile;

(b) 

the risk factors involved;

(c) 

the health status in:

(i) 

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

(ii) 

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

(d) 

surveillance conducted by operators in accordance with Article 24, including animal health visits as referred to in Article 25, or by other public authorities.

Article 28

Union surveillance programmes

1.  
The competent authority shall undertake surveillance as provided for in Article 26(1) within the framework 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 reports on the results of the implementation of that programme to the Commission.

Article 29

Delegation of powers

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

the design, means, diagnostic methods, frequency, intensity, targeted animal population, and sampling patterns of the surveillance provided for in Article 27;

(b) 

the criteria for the official confirmation 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 contents of surveillance programmes;

(ii) 

the information to be included in the submission of surveillance programmes in accordance with Article 28(2) and regular reports 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 implementing acts, lay down requirements concerning surveillance and surveillance programmes as provided for in Articles 26 and 28 and in the rules adopted pursuant to Article 29, as regards:

(a) 

establishing which of the listed diseases referred 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 reporting 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 referred to in Article 28.
3.  
The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 3

Eradication programmes

Article 31

Compulsory and optional eradication programmes

1.  

Member States which are not free, or not known to be free, from one or more of the listed diseases referred to in point (b) of Article 9(1) throughout their territory, or in zones or compartments thereof, shall:

(a) 

establish a programme for the eradication of, or demonstration of freedom from, that listed disease, to be carried out in the animal populations concerned by that disease and covering the relevant parts of their territory or the relevant zones or compartments thereof (‘compulsory eradication programme’), to apply until the conditions for the grant of disease–free status in the territory of the Member State or zone concerned, as provided for in Article 36(1), or compartment, as provided for in Article 37(2), are fulfilled;

(b) 

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

2.  
Member States which are not free, or not known to be free, from one or more of the listed diseases referred to in 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 concerned by the disease in question and covering the relevant parts of their territory or zones or compartments thereof (‘optional eradication programme’), shall submit a draft of that programme to the Commission for approval, where the Member State concerned 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 concerned, as provided for in Article 36(1), or compartment, 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 concerned withdraws the programme.

3.  

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

(a) 

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

(b) 

draft optional eradication programmes submitted to it for approval in accordance with paragraph 2,

if the conditions set out in this Chapter are met.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

4.  
On duly justified imperative grounds of urgency relating to a listed disease representing a risk having a highly significant impact, the Commission shall adopt immediately 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, approve an amendment proposed by the Member State concerned or withdraw the approval of eradication programmes approved in accordance with points (a) and (b) of paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

5.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

the disease control strategies, intermediate and final targets for specific diseases, and period of application of eradication programmes;

(b) 

derogations from the requirement for the submission of eradication programmes for approval, as provided for in point (b) of paragraph 1 of this Article and in paragraph 2 thereof, where such approval is not necessary due to the adoption 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 concerning derogations from the requirement for approval of eradication programmes as provided for in point (b) of this paragraph.

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 amending or discontinuing rules adopted pursuant to point (b) of this paragraph.

Article 32

Measures under compulsory and optional eradication programmes

1.  

Eradication programmes shall consist of at least the following measures:

(a) 

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

(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 delegated acts in accordance with Article 264 concerning 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–infection of the targeted animal population with the disease in question in establishments, zones and compartments;

(c) 

surveillance design, means, diagnostic methods, frequency, intensity, targeted animal population and sampling patterns;

(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 appropriate for the disease or species in question.

Article 33

Content of compulsory and optional eradication programmes submitted for approval to the Commission

Member States shall include the following information in applications for approval of compulsory and optional eradication programmes submitted to the Commission in accordance with Article 31(1) and (2):

(a) 

a description of the epidemiological situation of the listed disease covered by the compulsory or optional eradication programme in question;

(b) 

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

(c) 

a description of the disease control measures of the eradication programme as provided for in Article 32(1) and in the rules adopted pursuant to Article 32(2);

(d) 

a description of the organisation, supervision and roles of the parties involved in the eradication programme;

(e) 

the estimated duration of the eradication programme;

(f) 

the intermediate targets of, and the disease control strategies for implementing, the eradication programme.

Article 34

Reporting

Member States implementing eradication programmes shall submit to the Commission:

(a) 

reports enabling the Commission to monitor achievement of the intermediate targets of the on-going eradication programmes as referred to in point (f) of Article 33;

(b) 

a final report after completion of the eradication programme in question.

Article 35

Implementing powers

The Commission shall, by means of implementing acts, lay down rules concerning the information, format and procedural requirements provided for in Articles 31 to 34 as regards:

(a) 

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

(b) 

performance indicators;

(c) 

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

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 4

Disease–free status

Article 36

Disease–free Member States and zones

1.  

A Member State may apply to the Commission for approval of 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 anywhere in the territory of the Member State concerned or in the relevant zone or zones covered by the application;

(b) 

the disease agent is known not to be able to survive in the entire territory of the Member State, or in the relevant zone or zones covered by the application, according to the criteria referred to in point (a)(ii) of Article 39;

(c) 

in the case of listed diseases only transmitted by vectors, none of the vectors are present, or they are known not to be able to survive in the entire territory of the Member State, or in the relevant zone or zones covered by the application, according to the criteria referred to in point (a)(ii) of Article 39;

(d) 

freedom from the listed disease has been demonstrated by:

(i) 

an eradication programme complying with the rules laid down in Article 32(1) and rules adopted pursuant to paragraph 2 of that Article; or

(ii) 

historical and surveillance data.

2.  
Applications by Member States for disease–free status shall include evidence 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 approval of disease–free status for one or more of the listed diseases referred to in point (a) of Article 9(1), and in particular for approval 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 complying with the rules laid down in Article 32(1) and rules adopted pursuant to paragraph 2 of that Article; or

(ii) 

historical and surveillance data;

(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, approve, subject to amendments where necessary, 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 adopted in accordance with the examination procedure referred to in Article 266(2).

Article 37

Compartments

1.  

A Member State may apply to the Commission for recognition of the disease–free status of compartments for listed diseases referred to in point (a) of Article 9(1), and for the protection of the disease–free status of such a compartment 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 prevented at compartment level, taking into account the disease profile;

(b) 

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

(c) 

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

(i) 

Articles 99 and 100 for compartments keeping terrestrial animals and products thereof;

(ii) 

Articles 183 and 184 for compartments keeping aquaculture animals and products thereof.

2.  

A Member State may apply to the Commission for recognition of the disease–free status of compartments for one or more of the listed diseases referred 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 prevented at compartment level, taking into account the disease profile;

(b) 

one or more of the following conditions are complied with:

(i) 

the conditions laid down in Article 36(1) are fulfilled;

(ii) 

the establishments of the compartment covered by the application have started or resumed their activities and have established a common biosecurity management system designed to ensure the freedom from disease of that compartment;

(c) 

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

(d) 

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

(i) 

Articles 99 and 100 for compartments keeping terrestrial animals and products thereof;

(ii) 

Articles 183 and 184 for compartments keeping aquaculture animals and products thereof.

3.  
Applications by Member States for recognition of the disease–free status of compartments in accordance with paragraphs 1 and 2 shall include evidence demonstrating that the conditions laid down in those paragraphs are fulfilled.
4.  

The Commission shall, by means of implementing acts:

(a) 

recognise, subject to amendments where necessary, the disease–free status of compartments, when the conditions laid down in paragraph 1 or paragraph 2 and in paragraph 3 are fulfilled;

(b) 

determine for which of the listed diseases referred to in points (a), (b) and (c) of Article 9(1) the disease–free compartments may be established.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

5.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning provisions supplementing those contained in this Article, on:

(a) 

the requirements for recognition of the disease-free status of compartments as provided for in paragraphs 1 and 2 of this Article, based on the profile of the listed diseases referred to in points (a), (b) and (c) of Article 9(1), concerning at least:

(i) 

surveillance results and other evidence needed to substantiate freedom from disease;

(ii) 

biosecurity measures;

(b) 

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

(c) 

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

Article 38

Lists of disease–free Member States, zones or compartments

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 compartments 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 States in making the information contained in those lists available to the public by providing on its internet page the links to the internet–based information pages of the Member States.

Article 39

Delegation of powers concerning the disease–free status of Member States and zones

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

detailed rules for the disease–free status of Member States and zones thereof, based on the different disease profiles, concerning:

(i) 

the criteria to be used to substantiate claims by Member States that no listed species are present or able to survive 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 determine freedom from the disease in question, as referred to in point (d) of Article 36(1);

(iv) 

surveillance results and other evidence needed to substantiate freedom from disease;

(v) 

biosecurity measures;

(vi) 

restrictions 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 restricted zones (‘buffer zones’);

(viii) 

zones which are located in the territory of more than one Member State;

(b) 

derogations from the requirement for approval by the Commission of disease–free status for one or more listed diseases referred to in points (b) and (c) of Article 9(1), as laid down in Article 36(1), where such approval is not necessary on account of detailed rules for freedom from disease having been laid down in rules adopted pursuant to point (a) of this Article;

(c) 

the information to be provided by Member States to the Commission and the other Member States to substantiate declarations of disease–free status, without the adoption 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 concerning 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 compartments 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 concerned, or zones and compartments thereof;

(b) 

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

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 41

Maintenance of disease–free status

1.  

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

(a) 

the conditions for disease–free status laid down in Article 36(1) and 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 undertaken to verify that the territory, zone or compartment concerned continues to be free of the listed disease for which it was approved or recognised as having disease–free status;

(c) 

restrictions 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 approved or recognised, into the territory, zone or compartment concerned, in accordance with the rules laid down in Parts IV and V;

(d) 

other biosecurity measures are applied to prevent the introduction of the listed disease for which it was approved or recognised as having disease–free status.

2.  
A Member State shall immediately inform the Commission if the conditions referred to in paragraph 1 for maintaining disease–free status are no longer met.
3.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning the following conditions for maintaining disease–free status:

(a) 

surveillance as provided for in point (b) of paragraph 1;

(b) 

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

(a) 

where relevant, depending on the risk, suspend or restrict movements of the listed species, for the listed disease for which it was approved or recognised as having disease-free status, to other Member States, zones or compartments with a higher health status for that listed disease;

(b) 

where relevant for the prevention of the spread of a listed disease for which disease–free status has been approved or recognised, apply the disease control measures provided for in Title II of Part III.

2.  

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

(a) 

the suspected breach has not taken place; or

(b) 

the suspected breach has not had a significant impact and the Member State concerned can provide assurances that the conditions for maintaining its disease–free status are again fulfilled.

3.  
Where further investigation by the Member State concerned confirms that there has been an outbreak of the listed disease for which it obtained disease–free status, or that other significant breaches of the conditions for maintaining disease–free status as referred to in Article 41(1) have occurred, or where there is a significant likelihood of this having occurred, the Member State shall immediately inform the Commission thereof.
4.  
The Commission shall, by means of implementing acts, withdraw without undue delay the approval of the disease–free status of a Member State or zone granted in accordance with Article 36(4) or the recognition of the disease–free status of a compartment granted in accordance with Article 37(4) after obtaining the information from the Member State concerned that the conditions for maintaining the disease–free status are no longer met.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

5.  
On duly justified imperative grounds of extreme urgency, where the listed disease referred to in paragraph 3 of this Article spreads in a rapid manner, carrying with it the risk of a highly significant impact on animal or public health, the economy or society, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).
6.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning provisions supplementing the rules for the suspension, withdrawal and restoration of disease–free status set out in paragraphs 1 and 2 of this Article.



PART III

DISEASE AWARENESS, PREPAREDNESS AND CONTROL



TITLE I

DISEASE AWARENESS AND PREPAREDNESS



CHAPTER 1

Contingency plans and simulation exercises

Article 43

Contingency plans

1.  
The Member States shall, after appropriate consultation of experts and relevant stakeholders, draw up, and keep up to date, contingency plans and, where necessary, detailed instruction manuals laying down the measures to be taken in the Member State concerned in the event of the occurrence 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 contingency plans and, where applicable, detailed instruction manuals shall cover at least the following matters:

(a) 

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

(b) 

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

(c) 

access to:

(i) 

facilities;

(ii) 

laboratories;

(iii) 

equipment;

(iv) 

personnel;

(v) 

emergency funds;

(vi) 

all other appropriate materials and resources necessary for the rapid and efficient eradication of the listed diseases referred to in point (a) of Article 9(1) or of emerging diseases;

(d) 

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

(i) 

a functional central disease control centre;

(ii) 

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

(iii) 

operational expert groups;

(e) 

implementation of the disease control measures provided for in Chapter 1 of Title II for the listed diseases referred to in point (a) of Article 9(1) and for emerging diseases;

(f) 

provisions on emergency vaccination, where appropriate;

(g) 

principles for the geographical demarcation of the restricted zones established by the competent authority in accordance with Article 64(1);

(h) 

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

Article 44

Implementing powers for contingency plans

The Commission shall, by means of implementing acts, lay down necessary measures concerning the implementation in the Member States of the contingency plans provided for in Article 43(1).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 45

Simulation exercises

1.  

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

(a) 

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

(b) 

to verify the functionality of those contingency plans.

2.  
Where feasible and appropriate, simulation exercises shall be carried out in close collaboration with the competent authorities of neighbouring Member States and neighbouring third countries and territories.
3.  
Member States shall make available to the Commission and to the other Member States, on request, a report on the main results of the simulation exercises carried out.
4.  

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

(a) 

the frequencies of simulation exercises;

(b) 

simulation exercises covering more than one listed disease referred to in point (a) of Article 9(1).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 2

The use of veterinary medicinal products for disease prevention and control

Article 46

The use of veterinary medicinal products for disease prevention and control

1.  
The Member States may take measures concerning the use of veterinary medicinal products for listed diseases, to ensure the most efficient prevention or control of those diseases, provided that such measures are appropriate or necessary.

Those measures may cover the following:

(a) 

prohibitions and restrictions on the use of veterinary medicinal products;

(b) 

the compulsory use of veterinary medicinal products.

2.  

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

(a) 

the disease profile;

(b) 

the distribution of the listed disease in:

(i) 

the Member State concerned;

(ii) 

the Union;

(iii) 

where relevant, neighbouring third countries and territories;

(iv) 

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

(c) 

the availability and effectiveness of the veterinary medicinal products in question, and the risks attaching to them;

(d) 

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

(e) 

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

3.  
Member States shall take appropriate preventive measures concerning the use of veterinary medicinal products for scientific studies or for the purposes of developing and testing them under controlled conditions to protect animal and public health.

Article 47

Delegation of powers for the use of veterinary medicinal products

1.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning what might constitute appropriate and necessary measures as set out in Article 46, in relation to:

(a) 

prohibitions and restrictions on the use of veterinary medicinal products;

(b) 

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

(c) 

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

(d) 

surveillance for specific listed diseases following the use of vaccines and other veterinary 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 adopted pursuant to paragraph 1 of this Article.



CHAPTER 3

Antigen, vaccine and diagnostic reagent banks

Article 48

The establishment of Union antigen, vaccine and diagnostic reagent banks

1.  

For listed diseases referred to in point (a) of Article 9(1) in respect of which vaccination is not prohibited by a delegated act adopted pursuant to Article 47, the Commission may establish and be responsible for managing Union antigen, vaccine and diagnostic reagent banks for the storage and replacement of stocks of one or more of the following biological products:

(a) 

antigens;

(b) 

vaccines;

(c) 

vaccine master seed–stocks;

(d) 

diagnostic reagents.

2.  

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

(a) 

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

(b) 

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

(c) 

are maintained and moved in conformity with the appropriate biosecurity, biosafety and bio–containment requirements laid down in Article 16(1) and in accordance with delegated acts adopted pursuant to Article 16(2);

3.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

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

(b) 

the biosecurity, biosafety and bio–containment requirements for the operation of those banks, respecting the requirements provided for in Article 16(1) and taking into account the delegated acts adopted pursuant to Article 16(2).

Article 49

Access to the Union antigen, vaccine and diagnostic reagent banks

1.  

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

(a) 

in the first place, Member States; and

(b) 

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

2.  

The Commission shall, in the event of the limited availability of stocks, prioritise access to the stocks to be delivered pursuant to paragraph 1 based on:

(a) 

the disease circumstances under which the request is made;

(b) 

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

(c) 

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

Article 50

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

1.  

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

(a) 

which of those biological products are to be included in the Union antigen, vaccine and diagnostic reagent banks and for which of the listed diseases referred to in point (a) of Article 9(1);

(b) 

the types of those biological products that are to be included in the Union antigen, vaccine and diagnostic reagent banks and in what quantities for each specific listed disease referred to in point (a) of Article 9(1) for which the bank in question exists;

(c) 

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

(d) 

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

(e) 

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

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

2.  
On duly justified imperative 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 immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).

Article 51

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

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

Article 52

National antigen, vaccine and diagnostic reagent banks

1.  
Member States that have established national antigen, vaccine and diagnostic reagent banks for listed diseases referred to in 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 biosecurity, biosafety and bio–containment requirements laid down in point (a) of Article 16(1) and in delegated acts adopted in accordance with Article 16(2) and point (b) of Article 48(3).
2.  

Member States shall provide the Commission with up–to–date information on:

(a) 

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

(b) 

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

(c) 

any changes in the operation of such banks.

That information shall be treated as classified information by the Commission and shall not be published.

3.  
The Commission may, by means of implementing acts, lay down rules specifying the content, frequency and format of the submission of the information provided for in paragraph 2.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



TITLE II

DISEASE CONTROL MEASURES



CHAPTER 1

Disease control measures 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 listed disease in kept animals

Article 53

Obligations on operators and other relevant natural and legal persons concerned

1.  
In the event of suspicion of a listed disease as referred to in point (a) of Article 9(1) in kept animals, in addition to complying with the notification obligation laid down in Article 18(1) and pending any disease control measures being taken by the competent authority 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 concerned take the appropriate 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 unaffected animals or to humans.
2.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules for supplementing the disease control measures provided for in paragraph 1 of this Article.

Article 54

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

1.  
In the event of suspicion of a listed disease as referred to in point (a) of Article 9(1) in kept animals, the competent authority shall conduct without delay an investigation to confirm or rule out the presence of that listed disease.
2.  

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

(a) 

official veterinarians carry out a clinical examination of a representative sample of the kept animals of listed species for the listed disease in question;

(b) 

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

(c) 

such designated laboratories carry out examinations to confirm or rule out the presence of the listed disease in question.

3.  
The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing the rules for investigations by competent authorities as provided for in paragraph 1 of this Article.

Article 55

Preliminary disease control measures by competent authorities

1.  

The competent authority shall, in the event that it suspects the presence of a listed disease as referred to in point (a) of Article 9(1) in kept animals, carry out the following preliminary disease control measures, subject to national requirements for gaining access to private residences, pending the results of the investigation 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 concerned, or any other location where the disease is suspected of having occurred, including locations where the suspected disease may have originated, under official surveillance;

(b) 

compile an inventory of:

(i) 

the kept animals in the establishment, food and feed business, or animal by–products establishment concerned, 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 appropriate biosecurity measures are applied to prevent the spreading of that listed disease agent to other animals or to humans;

(d) 

when appropriate to prevent the further spread of the disease agent, ensure that the kept animals of listed species for that listed disease are isolated, and that they are prevented from coming into contact with wildlife;

(e) 

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

(f) 

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

(i) 

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

(ii) 

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

(g) 

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

2.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing those laid down in paragraph 1 of this Article as regards the specific and detailed disease control measures to be taken depending on the listed disease referred to in point (a) of Article 9(1), based on the risks involved for:

(a) 

the species or category of animals concerned;

(b) 

the type of production concerned.

Article 56

Review and extension of the preliminary disease control measures

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

(a) 

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

(i) 

the investigation provided for in Article 54(1);

(ii) 

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

(b) 

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



Section 2

Epidemiological enquiry

Article 57

Epidemiological enquiry

1.  
The competent authority shall carry out an epidemiological enquiry in the event of the confirmation of a listed disease as referred to in point (a) of Article 9(1) in animals.
2.  

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

(a) 

identify the likely origin of the listed disease in question and the means of its spread;

(b) 

calculate 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 suspected listed disease may have become infected, infested or contaminated;

(d) 

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

(e) 

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



Section 3

Disease confirmation in kept animals

Article 58

Official confirmation by the competent authority of a listed disease as referred to in point (a) of Article 9(1)

1.  

The competent authority shall base an official confirmation of a listed disease as referred 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);

(b) 

the preliminary or final results of the epidemiological enquiry provided for in Article 57(1);

(c) 

other available epidemiological data.

2.  
The Commission shall adopt delegated acts in accordance with Article 264 concerning the requirements to be fulfilled for the official confirmation referred to in paragraph 1 of this Article.

Article 59

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

The competent authority shall continue to apply the preliminary disease control measures provided for in Article 55(1) and Article 56 until the presence of the listed disease in question, as referred to in point (a) of Article 9(1), has been ruled out on the basis of the information referred to in Article 58(1) or rules adopted pursuant to Article 58(2).



Section 4

Disease control measures in the event of confirmation of disease in kept animals

Article 60

Immediate disease control measures to be taken by the competent authority

In the event of an official confirmation in accordance with Article 58(1) of an outbreak of a listed disease as referred to in point (a) of Article 9(1) in kept animals, the competent authority shall immediately:

(a) 

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

(b) 

establish a restricted zone appropriate for that listed disease;

(c) 

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

Article 61

Affected establishments and other locations

1.  

In the event of an outbreak of a listed disease as referred to in point (a) of Article 9(1) in kept animals, the competent authority 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 referred to in point (a) of Article 60, in order to prevent the further spread of that listed disease:

(a) 

the imposition of restrictions on movements of persons, animals, products, vehicles or any other material or substance that may be contaminated and contribute to the spread of the listed disease;

(b) 

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

(c) 

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

(d) 

the vaccination or treatment with other veterinary medicinal products of kept animals in accordance with Article 46(1) and Article 69 and any delegated acts adopted pursuant to Article 47;

(e) 

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

(f) 

the cleaning, disinfection, control of insects and rodents, or other necessary biosecurity 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 sufficient number of appropriate samples needed to complete the epidemiological enquiry provided for in Article 57(1);

(h) 

the laboratory examination of samples;

(i) 

any other appropriate measures.

2.  

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

(a) 

the disease profile;

(b) 

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

3.  

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

(a) 

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

(b) 

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

Article 62

Epidemiologically linked establishments and locations

1.  
The competent authority shall extend the disease control measures provided for in Article 61(1) to other establishments, epidemiological units therein, food or feed businesses, or animal by–products establishments, or any other location, or means of transport where the epidemiological enquiry provided for in Article 57(1) or the results of clinical or laboratory investigations or other epidemiological data, give reason to suspect the spread to, from or through them of the listed disease referred to in point (a) of Article 9(1) in respect of which such measures were taken.
2.  
If the epidemiological enquiry provided for in Article 57(1) shows that the likely origin of the listed disease referred to in point (a) of Article 9(1) is another Member State, or if it is likely that that listed disease has spread to another Member State, the competent authority shall inform that Member State and the Commission without delay.
3.  
Should any of the events referred to in paragraph 2 occur, the competent authorities of the different Member States shall cooperate in a further epidemiological enquiry and in the application of disease control measures.

Article 63

Delegation of powers in respect of disease control measures in affected and epidemiologically linked establishments and other locations

The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules on the disease control measures to be taken by the competent authority in accordance with Articles 61 and 62 in affected and epidemiologically linked establishments, food or feed businesses, or animal by–products establishments, and other locations in respect of any listed disease referred to in point (a) of Article 9(1), including rules on which disease control measures referred to in Article 61(1) are to be applied in relation to each listed disease.

Those detailed rules shall cover the following matters:

(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 necessary biosecurity measures as provided for in point (f) of Article 61(1), specifying, where appropriate, the use of biocidal products for those purposes;

(c) 

the conditions and requirements for sampling and laboratory 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 necessary disease control measures provided for in Article 62 in epidemiologically linked establishments, other locations and means of transport.

Article 64

Establishment of restricted zones by the competent authority

1.  

The competent authority shall establish a restricted zone as referred 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 listed disease as referred to in point (a) of Article 9(1) in kept animals has occurred, where appropriate taking into account:

(a) 

the disease profile;

(b) 

the geographical situation of the restricted zone;

(c) 

the ecological and hydrological factors of the restricted zone;

(d) 

the meteorological conditions;

(e) 

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

(f) 

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

(g) 

the results of laboratory tests;

(h) 

the disease control measures applied;

(i) 

other relevant epidemiological factors.

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

2.  

The competent authority shall continuously assess and review the situation and, when appropriate in order to prevent the spread of the listed disease referred to in point (a) of Article 9(1), shall:

(a) 

adapt the boundaries of the restricted zone;

(b) 

establish additional restricted zones.

3.  
Where restricted zones as provided for in paragraph 1 are situated in the territory of more than one Member State, the competent authorities of those Member States shall cooperate in establishing them.
4.  
The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules for the establishment and modification of restricted zones, including protection or surveillance zones.

Article 65

Disease control measures in restricted zones

1.  

The competent authority 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 restricted zone concerned, in order to prevent the further spread of a listed disease as referred to in point (a) of Article 9(1):

(a) 

the identification of establishments, food or feed businesses, animal by–products establishments or other locations with kept animals of listed species for that listed disease;

(b) 

visits to establishments, food or feed businesses, animal by–products establishments or other locations with kept animals of listed species for that listed disease, and, where necessary, examinations, sampling and laboratory examination of the samples taken;

(c) 

the imposition of conditions for the movement of persons, animals, products, feed, vehicles and any other material or substance that may be contaminated or contribute to the spread of that listed disease within and from the restricted zone and transport through the restricted zone;

(d) 

biosecurity requirements for:

(i) 

the production, processing and distribution of products of animal origin;

(ii) 

the collection and disposal of animal by–products;

(iii) 

the collection, storage and handling of germinal products;

(e) 

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

(f) 

cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures;

(g) 

the designation or where relevant, approval of a food business establishment for the purposes of the slaughtering of animals or the treatment of products of animal origin originating from the restricted zone;

(h) 

the identification and traceability requirements for the movement of animals, germinal products or products of animal origin;

(i) 

other necessary biosecurity and risk-mitigating measures to minimise the risk of the spread of that listed disease.

2.  

The competent authority shall:

(a) 

take all necessary measures to fully inform persons in the restricted zone of the restrictions in force and the nature of the disease control measures;

(b) 

impose the necessary obligations on operators in order to prevent the further spread of the listed disease in question.

3.  

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

(a) 

the disease profile;

(b) 

the types of production;

(c) 

the feasibility, availability and effectiveness of those disease control measures.

Article 66

Operators' obligations regarding movements in restricted zones

1.  
In restricted zones as provided for in Article 64(1), operators shall only move the kept animals and products with the permission of the competent authority and in accordance with any instructions given by that authority.
2.  
Operators keeping animals and products in a restricted zone as provided for in Article 64(1) shall notify to the competent authority intended movements of kept animals and products within or out of the restricted zone in question. In so far as the competent authority has imposed notification obligations in accordance with point (b) of Article 65(2), the operators concerned shall notify in accordance with those obligations.

Article 67

Delegation of powers concerning disease control measures in restricted zones

The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules on the disease control measures to be taken in restricted zones as provided for in Article 65(1) for each listed disease referred to in point (a) of Article 9(1), including rules on which 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 matters:

(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 necessary biosecurity measures as provided for in point (f) of Article 65(1), specifying, where appropriate, the use of biocidal products for those purposes;

(c) 

the necessary surveillance which is to be conducted following the application of the disease control measures and laboratory examinations provided for in point (b) of Article 65(1);

(d) 

other specific disease control measures to limit the spread of specific listed diseases as referred to in point (a) of Article 9(1).

Article 68

Maintaining disease control measures in restricted zones and delegated acts

1.  

The competent authority shall continue to apply the disease control measures provided for in this Section until the following conditions are met:

(a) 

the disease control measures appropriate to the listed disease referred to in point (a) of Article 9(1) for which they were applied have been carried out;

(b) 

the final cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures has been carried out as appropriate for:

(i) 

the listed disease referred to in point (a) of Article 9(1) for which the disease control measures have been applied;

(ii) 

the affected species of kept animals;

(iii) 

the type of production;

(c) 

adequate surveillance, as appropriate for the listed disease referred to in point (a) of Article 9(1) for which the disease control measures have been applied, and for the type of establishment or location concerned, has been carried out in the restricted zone substantiating the eradication of that listed disease.

2.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules for the disease control measures to be taken by the competent authority, as provided for in paragraph 1, in relation to:

(a) 

the final procedures for cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures and, where appropriate, the use of biocidal products for those purposes;

(b) 

the design, means, methods, frequency, intensity, targeted animal population and sampling patterns of surveillance aimed at the restoration of disease–free status after the outbreak;

(c) 

repopulation of the restricted zone concerned 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 empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules for the disease control measures to be taken by the competent authority, as provided for in paragraph 1, in relation to other disease control measures necessary for the restoration of disease–free status.

Article 69

Emergency vaccination

1.  

Where relevant for the effective control of a listed disease as referred to in point (a) of Article 9(1) for which disease control measures apply, the competent authority 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 competent authority shall take the following into account:

(a) 

the requirements for emergency 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 delegated acts adopted 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-mitigating measures to prevent the spread of listed diseases and surveillance as laid down in any delegated acts adopted in accordance with points (c) and (d) of Article 47(1).



Section 5

Wild animals

Article 70

Wild animals

1.  

Where the competent authority of an affected Member State suspects or officially confirms the presence of a listed disease as referred to in point (a) of Article 9(1) in wild animals, it shall:

(a) 

conduct, where relevant for that particular listed disease, surveillance in the wild animal population;

(b) 

take the necessary disease prevention and control measures.

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 empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

criteria and procedures for surveillance pursuant to point (a) of paragraph 1 of this Article in the case of official confirmation 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 confirmation of a listed disease as referred to in point (a) of Article 9(1).

When adopting those delegated acts, the Commission shall take into account the disease profile and the listed species for the listed disease referred to paragraph 1 of this Article.



Section 6

Additional disease control measures by the Member States, coordination by the Commission and temporary special disease control rules

Article 71

Additional disease control measures, coordination of measures and temporary special disease control rules concerning Sections 1 to 5 (Articles 53 to 70)

1.  

Member States 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 delegated acts adopted pursuant to Article 63, Article 67 and Article 68(2), provided that such measures respect the rules laid down in this Regulation and are necessary and proportionate 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 concerned;

(c) 

the species and categories of animals involved;

(d) 

economic or social conditions.

2.  

Member States shall inform the Commission without delay of:

(a) 

the disease control measures taken by their competent authority as provided for in Articles 58, 59, 61, 62, 64 and 65, Article 68(1), Article 69 and Article 70(1) and (2) and in any delegated acts adopted 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 competent authority and any additional disease control measures taken by the Member State concerned, in accordance with this Chapter, and may, by means of implementing acts, lay down special disease control measures for a limited period of time, under conditions appropriate to the epidemiological situation, where:

(a) 

those disease control measures are found not to be suited to the epidemiological situation;

(b) 

the listed disease referred to in point (a) of Article 9(1) appears to be spreading despite the disease control measures taken in accordance with this Chapter.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

4.  
On duly justified imperative grounds of urgency relating to a disease representing an emerging risk of a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).



CHAPTER 2

Disease control measures 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 operators and other relevant natural and legal persons concerned in relation to listed diseases as referred to in point (b) of Article 9(1)

1.  
In the event of suspicion of a listed disease as referred to in point (b) of Article 9(1) in kept animals, in addition to complying with the notification obligation laid down in Article 18(1) and pending any disease control measures being taken by the competent authority in accordance with Article 74(1), Member States shall take measures to ensure that operators and other relevant natural and legal persons concerned take disease control measures as referred to in point (a) of Article 74(1) and in any delegated acts adopted 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 unaffected animals or to humans.
2.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules for supplementing the disease control measures as provided for in paragraph 1 of this Article.

Article 73

Investigation by the competent authority in the event of suspicion of a listed disease as referred to in point (b) of Article 9(1)

1.  
In the event of suspicion of a listed disease as referred to in point (b) of Article 9(1) in kept animals, the competent authority shall conduct without delay an investigation to confirm or rule out the presence of that listed disease.
2.  

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

(a) 

official veterinarians carry out a clinical examination of a representative sample of the kept animals of listed species for the listed disease in question;

(b) 

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

(c) 

such designated laboratories carry out examinations to confirm or rule out the presence of the listed disease in question.

3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing the rules for investigations as provided for in paragraph 1 of this Article.

Article 74

Preliminary disease control measures by the competent authority for listed diseases as referred to in point (b) of Article 9(1)

1.  

The competent authority shall, in the event that it suspects a listed disease as referred to in point (b) of Article 9(1) in kept animals, carry out the following preliminary disease control measures, subject to national requirements for gaining access to private residences, pending the results of the investigation 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;

(b) 

initiate, where necessary, an epidemiological enquiry, taking into account the rules for such enquiry laid down in Article 57(1).

2.  
In addition to the measures referred to in paragraph 1, the competent authority may, in the cases referred to in that paragraph, take additional preliminary disease control measures, provided that those measures respect the provisions of this Regulation and are in accordance with Union law.
3.  

The preliminary disease control measures provided for in paragraphs 1 and 2 shall be appropriate and proportionate to the risk posed by the listed disease in question, taking into account the following:

(a) 

the disease profile;

(b) 

the kept animals affected;

(c) 

the health status of the Member State, zone, compartment or establishment in which the listed disease is suspected;

(d) 

the preliminary disease control measures provided for in Article 55(1) and Article 56 and in any delegated act adopted pursuant to Article 55(2).

4.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning 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 preliminary 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 preliminary 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 temporary restricted zones which are appropriate in light of the disease profile.

Article 75

Review and extension of the preliminary 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 competent authority, as appropriate, following the findings of the investigation provided for in Article 73(1) and, where relevant, the epidemiological enquiry provided for in point (b) of Article 74(1);

(b) 

further extended to other locations, as referred to in point (b) of Article 74(4), where necessary.

Article 76

Obligations of operators and other relevant natural and legal persons and measures to be taken by the competent authority in the event of suspicion of listed diseases as referred 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 compartments thereof, as provided for in Article 31(2), that Member State shall take measures to ensure that operators and other relevant natural and legal persons concerned take appropriate measures as provided for in Article 72(1), pending any disease control measures being taken by the competent authority in accordance with paragraph 2 of this Article.
2.  

The competent authority 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 delay an investigation to confirm or rule out the presence of that listed disease in accordance with Article 73(1) and (2);

(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 preliminary disease control measures provided for in Article 74(1) and (2).

3.  
The competent authority shall review and extend the preliminary 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 compartments in accordance with Article 37(2).
5.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing rules in respect of:

(a) 

the disease control measures provided for in paragraph 1;

(b) 

the investigation provided for in point (a) of paragraph 2;

(c) 

the preliminary 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 confirmation in kept animals

Article 77

Official confirmation of disease by the competent authority

1.  

The competent authority shall base an official confirmation of a listed disease as referred 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 enquiry provided for in point (b) of Article 74(1), where relevant;

(c) 

other available epidemiological data.

2.  
The Commission shall adopt delegated acts in accordance with Article 264 concerning the requirements to be fulfilled for the official confirmation referred to in paragraph 1.

Article 78

Lifting preliminary disease control measures when the occurrence of a disease is ruled out

The competent authority shall continue to apply the preliminary 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 adopted pursuant to Article 77(2).



Section 3

Disease control measures in the event of confirmation of disease in kept animals

Article 79

Disease control measures by the competent authority for listed diseases as referred to in point (b) of Article 9(1)

In the event of an official confirmation in accordance with Article 77(1) of an outbreak of a listed disease as referred to in point (b) of Article 9(1) in kept animals, the competent authority shall, in a Member State, zone or compartment, as relevant for that outbreak:

(a) 

apply the disease control measures laid down in the compulsory eradication programme provided for in Article 31(1) for that listed disease; or

(b) 

where the Member State or zone, or compartment, 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 proportionate to the risk posed by the listed disease in question, and

(ii) 

where necessary, initiate the compulsory eradication programme for that listed disease.

Article 80

Disease control measures to be taken by the competent authority for listed diseases referred to in Article 9(1)(c)

1.  
In the event of an official confirmation 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 compartments thereof, as provided for in Article 31(2), as relevant for that listed disease and that outbreak, the competent authority shall apply the disease control measures laid down in the optional eradication programme.
2.  

The competent authority 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 proportionate to the risk posed by the listed disease in question and shall take into account:

(a) 

the disease profile;

(b) 

the kept animals affected;

(c) 

economic and social impacts.

3.  

In the event of an official confirmation 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 compartment that has obtained disease–free status in accordance with Article 36 or Article 37, and in order to maintain that status, the competent authority shall take one or more of the measures laid down in Articles 53 to 69. Those measures shall be proportionate to the risk posed by the listed disease in question and shall take into account:

(a) 

the disease profile;

(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 competent authority of an affected Member State suspects or officially confirms 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 concerned, as relevant for that outbreak:

(a) 

apply the disease control measures laid down in the compulsory eradication programme provided for ►C3   in Article 31(1) ◄ for that listed disease; or

(b) 

initiate a compulsory 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 necessary in order to control and prevent the spread of that disease.

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 competent authority suspects or officially confirms a listed disease as referred 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 envisaged in the optional eradication programme provided for in Article 31(2) for that listed disease, the competent authority shall apply the disease control measures laid down in that optional eradication programme throughout the territory of the Member State, area or zone concerned, as relevant for that suspicion or official confirmation.
2.  

The competent authority 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 proportionate to the risk posed by the listed disease in question and shall take into account:

(a) 

the disease profile;

(b) 

the affected 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 confirmation 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 compartment that has obtained disease–free status in accordance with Article 36 or Article 37, and in order to maintain that status, the competent authority shall take one or more of the measures laid down in Articles 53 to 69. Those measures shall be proportionate to the risk posed by the listed disease in question and shall take into account:

(a) 

the disease profile;

(b) 

the affected 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 temporary special disease control rules

Article 83

Coordination of measures by the Commission and temporary special rules concerning Sections 1 to 4

1.  

Member States shall inform the Commission of:

(a) 

disease control measures taken by their competent authorities in accordance with Articles 77(1), 78, 79 and 81 and with any delegated acts adopted pursuant to Article 77(2) in respect of a listed disease as referred to in point (b) of Article 9(1);

(b) 

disease control measures taken by their competent authorities in accordance with Articles 77(1), 78, 80(1) and 82 and with any delegated acts adopted pursuant to Article 77(2) in respect of a listed disease as referred to in point (c) of Article 9(1).

2.  

The Commission shall review the disease situation and the disease control measures taken by the competent authority in accordance with this Chapter and may, by means of implementing acts, lay down special rules for disease control measures for a limited period of time in respect of a listed disease as referred to in point (b) or point (c) of Article 9(1), under conditions appropriate to the epidemiological situation, where:

(a) 

those disease control measures taken by the competent authority in question are found not to be suited to the epidemiological situation;

(b) 

that listed disease appears to be spreading despite the disease control measures taken in accordance with this Chapter, where relevant.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

3.  
On duly justified 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 referred to in Article 266(3).



PART IV

REGISTRATION, APPROVAL, TRACEABILITY AND MOVEMENTS



TITLE I

TERRESTRIAL ANIMALS, GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN FROM TERRESTRIAL ANIMALS



CHAPTER 1

Registration, approval, record-keeping and registers



Section 1

Registration of establishments and certain types of operators

Article 84

Obligation of operators to register establishments

1.  

Operators of establishments keeping terrestrial animals or collecting, producing, processing or storing germinal products shall, in order for their establishments to be registered in accordance with Article 93, before they commence such activities:

(a) 

inform the competent authority of any such establishment under their responsibility;

(b) 

provide the competent authority with the following information:

(i) 

the name and address of the operator concerned;

(ii) 

the location of the establishment and a description of its facilities;

(iii) 

the categories, species and numbers or quantities of kept terrestrial 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 which are relevant for the purpose of determining the risk posed by it.

2.  

Operators of establishments referred to in paragraph 1 shall inform the competent authority of:

(a) 

any changes in the establishment in question concerning the matters referred to in point (b) of paragraph 1;

(b) 

any cessation of activity by the operator or establishment concerned.

3.  
Establishments which are subject to approval in accordance with Article 94(1) shall not be required to provide the information referred to in paragraph 1 of this Article.

Article 85

Derogations from the obligation of operators to register establishments

By way of derogation from Article 84(1), Member States may exempt from the registration requirement certain categories of establishments posing an insignificant risk, as provided for in an implementing act adopted in accordance with Article 86(2). Member States shall inform the Commission of such exemptions.

Article 86

Implementing powers concerning the obligation of operators to register establishments

1.  
The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators 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 concerning the types of establishments that may be exempted by the Member States from the registration requirement in accordance with Article 85, on the basis of:

(a) 

the species, categories 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 terrestrial animals or germinal products into and out of the establishment.

3.  
The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 87

Registration obligations of transporters of kept ungulates and delegated acts

1.  

Transporters of kept ungulates engaged in the transportation of those animals between Member States or between a Member State and a third country shall, in order to be registered in accordance with Article 93, before they commence such activities:

(a) 

inform the competent authority of their activity;

(b) 

provide that competent authority with information on:

(i) 

the name and address of the transporter concerned;

(ii) 

the categories, species and numbers of kept ungulates for which transportation is planned;

(iii) 

the type of transport;

(iv) 

the means of transport.

2.  

Transporters as referred to in paragraph 1 shall inform the competent authority of:

(a) 

any changes concerning the matters referred to in point (b) of paragraph 1;

(b) 

any cessation of the transport activity.

3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 supplementing the rules provided for in paragraph 1 of this Article, requiring other types of transporters whose transport activity poses specific and significant risks for certain species or categories of animals to provide adequate information for the purposes of registration of their activity.

Article 88

Derogations from the registration obligation of transporters of kept ungulates

By way of derogation from Article 87(1), Member States may exempt from the registration requirement certain categories of transporters whose transport activity poses an insignificant risk, as provided for in an implementing act adopted in accordance with Article 89(2). Member States shall inform the Commission of such exemptions.

Article 89

Implementing powers concerning the registration obligation of transporters

1.  
The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by transporters 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 concerning the types of transporters 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 transport the ungulates in question; and

(b) 

the categories, species and number of ungulates which they transport.

3.  
The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 90

Registration obligation of operators conducting assembly operations independently of an establishment

1.  

Operators conducting assembly operations for kept ungulates and poultry, independently of an establishment, including those who buy and sell animals, shall, in order to be registered in accordance with Article 93, before they commence their activities, provide the competent authority with information on:

(a) 

the name and address of the operator concerned;

(b) 

the species and categories of kept ungulates and poultry covered by their activity.

2.  

Operators as referred to in paragraph 1 shall inform the competent authority of:

(a) 

any changes concerning the matters referred to in paragraph 1;

(b) 

any cessation of activity by the operator concerned.

Article 91

Derogations from the registration obligation of operators conducting assembly operations

By way of derogation from Article 90(1), Member States may exempt from the registration requirement certain categories of operators conducting assembly operations posing an insignificant risk, as provided for in an implementing act adopted in accordance with Article 92(2). Member States shall inform the Commission of such exemptions.

Article 92

Implementing powers concerning the registration obligation of operators conducting assembly operations

1.  
The Commission may, by means of implementing acts, lay down rules concerning 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 concerning the types of operators that may be exempted by Member States from the registration requirement in accordance with Article 91, provided that the activity of such operators poses an insignificant risk and on the basis of species, the categories and numbers of kept terrestrial animals covered by their activity.
3.  
The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 93

Obligation of the competent authority concerning registration

A competent authority shall register:

(a) 

establishments in the register provided for in Article 101(1), where the operator concerned has provided the information required in accordance with Article 84(1);

(b) 

transporters in the register provided for in Article 101(1), where the transporter concerned has provided the information required in accordance with Article 87(1) and (3);

(c) 

operators conducting assembly operations independently of an establishment, in the register provided for in Article 101(1), where the operator concerned has provided the information required in accordance with Article 90(1).

The competent authority shall assign each establishment, transporter and operator as referred to in points (a) to (c) of the first paragraph with a unique registration number.



Section 2

Approval of certain types of establishments

Article 94

Approval of certain establishments and delegated acts

1.  

Operators of the following types of establishments shall apply to the competent authority for approval in accordance with Article 96(1) and shall not commence their activities until their establishment has been approved in accordance with Article 97(1):

(a) 

establishments for assembly operations of ungulates and poultry from which those animals are moved to another Member State or which receive animals from another Member State;

(b) 

germinal product establishments for bovine, porcine, ovine, caprine and equine animals from which germinal products of those animals are moved to another Member State;

(c) 

hatcheries from which hatching eggs or poultry are moved to another Member State;

(d) 

establishments keeping poultry from which poultry intended for purposes other than slaughter or hatching eggs are moved to another Member State;

(e) 

any other type of establishment for kept terrestrial animals which poses a significant risk and is required to be approved in accordance with rules laid down in a delegated act adopted in accordance with point (b) of paragraph 3.

2.  

Operators shall cease activity at an establishment as referred to in paragraph 1 where:

(a) 

the competent authority withdraws or suspends its approval in accordance with Article 100(2); or

(b) 

in the event of conditional approval, granted in accordance with Article 99(3), the establishment in question fails to comply with the outstanding requirements referred to in Article 99(3) and does not obtain a final approval in accordance with Article 97(1).

3.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

derogations from the requirement for operators of the types of establishments referred to in points (a) to (d) of paragraph 1 to apply to the competent authority for approval, where those establishments pose an insignificant risk;

(b) 

the types of establishments which must be approved 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 adopting delegated acts as provided for in paragraph 3, the Commission shall base those acts on the following criteria:

(a) 

the species and categories of kept terrestrial animals or germinal products in an establishment;

(b) 

the number of species and number of kept terrestrial animals or germinal products kept in an establishment;

(c) 

the type of establishment and type of production; and

(d) 

the movements of kept terrestrial animals or germinal products into and out of those types of establishments.

Article 95

Approval of status of confined establishments

Operators of establishments wishing to obtain the status of a confined establishment shall:

(a) 

apply to the competent authority for approval 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 delegated acts adopted in accordance with Article 137(2) only after their establishment has obtained an approval of that status from the competent authority in accordance with Articles 97 and 99.

Article 96

Obligation of operators to provide information with a view to obtaining approval and implementing acts

1.  

Operators shall, for the purposes of their application for approval of their establishment as provided for in Article 94(1) and point (a) of Article 95, provide the competent authority with the following information:

(a) 

the name and address of the operator concerned;

(b) 

the location of the establishment concerned and a description of its facilities;

(c) 

the categories, species and number of kept terrestrial animals or germinal products relevant for the approval which are kept on the establishment;

(d) 

the type of establishment;

(e) 

other aspects of the establishment, related to its specificity, which are relevant in determining the risk, if any, posed by it.

2.  

Operators of establishments as referred to in paragraph 1 shall inform the competent authority of:

(a) 

any changes in the establishments concerning the matters referred to in points (a), (b) or (c) of paragraph 1;

(b) 

any cessation of activity by the operator or establishment concerned.

3.  
The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators in their application for approval 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 adopted in accordance with the examination procedure referred to in Article 266(2).

Article 97

Granting of, and conditions for, approval of establishments and delegated acts

1.  

Competent authorities shall only grant approval of establishments as provided for in Article 94(1) and point (a) of Article 95 where such establishments:

(a) 

comply with the following requirements, where appropriate, in relation to:

(i) 

quarantine, isolation and other biosecurity measures taking into account the requirements provided for in point (b) of Article 10(1) and any rules adopted pursuant to Article 10(2);

(ii) 

surveillance requirements as provided for in Article 24 and, where relevant for the type of establishment concerned and the risk involved, in Article 25;

(iii) 

record-keeping as provided for in Articles 102 and 103 and any rules adopted 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 acceptable level, taking into account the type of establishment concerned;

(ii) 

of a capacity adequate for the number of kept terrestrial animals or the volume of germinal products concerned;

(c) 

do not pose an unacceptable risk as regards the spread of diseases, taking into account the risk-mitigation measures in place;

(d) 

have adequately trained personnel for the activity of the establishment concerned;

(e) 

have in place a system which enables the operator concerned to demonstrate to the competent authority compliance with points (a) to (d).

2.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

quarantine, isolation and other biosecurity measures as referred to in point (a)(i) of paragraph 1;

(b) 

surveillance as referred to in point (a)(ii) of paragraph 1;

(c) 

facilities and equipment as referred to in point (b) of paragraph 1;

(d) 

responsibilities, competence and specialised training of personnel and veterinarians as provided for in point (d) of paragraph 1 for the activity of germinal products establishments and establishments for assembly operations of ungulates and poultry;

(e) 

the necessary supervision by the competent authority of germinal products establishments and establishments for assembly operations of ungulates and poultry.

3.  

When establishing the rules to be laid down in the delegated acts to be adopted pursuant to paragraph 2, the Commission shall base those rules on the following matters:

(a) 

the risks posed by each type of establishment;

(b) 

the species and categories of kept terrestrial animals relevant for the approval;

(c) 

the type of production concerned;

(d) 

typical movement patterns of the type of establishment and species and categories of animals kept in those establishments.

Article 98

Scope of the approval of establishments

The competent authority shall expressly specify in the approval 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 which of the types of establishments referred to in Article 94(1) and Article 95, and in the rules adopted pursuant to point (b) of Article 94(3), the approval applies;

(b) 

for which species and categories of kept terrestrial animals or germinal products of those species the approval applies.

Article 99

Procedures for the granting of approval by the competent authority

1.  
The competent authority shall establish procedures for operators to follow when applying for approval of their establishments in accordance with Article 94(1), Article 95 or Article 96(1).
2.  
Upon receipt of an application for approval from an operator, the competent authority shall, in accordance with Article 94(1) or point (a) of Article 95, make an on–site visit.
3.  
Provided that the requirements referred to in Article 97 and paragraphs (1) and (2) of this Article are fulfilled, the competent authority shall grant the approval.
4.  
Where an establishment does not fulfil all requirements for approval as referred to in Article 97, the competent authority may grant conditional approval of an establishment if it appears, on the basis of the application by the operator concerned and the subsequent on–site visit as provided for in paragraph 2 of this Article, that the establishment meets all the main requirements that provide sufficient guarantees that the establishment does not pose a significant risk.
5.  
Where conditional approval has been granted by the competent authority in accordance with paragraph 4 of this Article, it shall grant full approval 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 approval, or from documentation provided by the operator within three months from that date, that the establishment meets all the requirements for approval provided for in Article 97(1) and the rules adopted pursuant to Article 97(2).

Where the on–site 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 competent authority may prolong the conditional approval. However, conditional approval shall not be granted for a period exceeding, in total, six months.

Article 100

Review, suspension and withdrawal of approvals by the competent authority

1.  
The competent authority shall keep approvals of establishments granted in accordance with Articles 97 and 99 under review, at appropriate intervals based on the risk involved.
2.  
Where a competent authority identifies serious deficiencies in an establishment as regards compliance with the requirements laid down in Article 97(1) and the rules adopted pursuant to Article 97(2), and the operator of that establishment is not able to provide adequate guarantees that those deficiencies will be eliminated, the competent authority shall initiate procedures to withdraw the approval of the establishment.

However, the competent authority may merely suspend, rather than withdraw, approval of an establishment where the operator can guarantee that it will eliminate those deficiencies within a reasonable period of time.

3.  
Approval shall only be granted after withdrawal or restored after suspension in accordance with paragraph 2 when the competent authority is satisfied that the establishment fully complies with all the requirements of this Regulation appropriate for that type of establishment.



Section 3

Registers of the competent authority

Article 101

Registers to be kept by the competent authority

1.  

Each competent authority shall establish and keep up to date registers of:

(a) 

all establishments and operators registered with it pursuant to Article 93;

(b) 

all establishments approved by it in accordance with Articles 97 and 99.

It shall make the registers referred to in points (a) and (b) of the first subparagraph available to the Commission and to the competent authorities 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 approved 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 terrestrial animals and germinal products thereof between Member States.

2.  
Where appropriate and relevant, a competent authority may combine the registration referred to in point (a) of the first subparagraph of paragraph 1 and the approvals referred to in point (b) of the first subparagraph of paragraph 1 with registration for other purposes.
3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning 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 availability 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-keeping obligations of operators of establishments other than germinal products establishments

1.  

Operators of establishments subject to the requirement of registration in accordance with Article 93, or approval in accordance with Article 97(1), shall keep and maintain records containing at least the following information:

(a) 

the species, categories, number and, where applicable, identification of kept terrestrial animals on their establishment;

(b) 

movements of kept terrestrial animals into and out of their establishment, stating as appropriate:

(i) 

their place of origin or destination;

(ii) 

the date of such movements;

(c) 

the documents required to accompany kept terrestrial animals arriving at or leaving 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 adopted pursuant to Articles 118 and 120 and points (b) and (c) of Article 144(1);

(d) 

mortality of kept terrestrial animals on their establishment;

(e) 

biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for:

(i) 

the species and categories 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 exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
3.  

Operators of establishments shall keep the records provided for in paragraphs 1 and 2 on their establishment concerned and shall:

(a) 

make them immediately available to the competent authority on request;

(b) 

retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.

4.  

By way of derogation from paragraph 3, operators may be exempted from the obligation to keep records of some or all of the matters provided for in paragraph 1 when the operator concerned:

(a) 

has access to the computerised database referred 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–date information entered directly into the computerised database.

Article 103

Record-keeping obligations of germinal product establishments

1.  

Operators of germinal product establishments shall keep and maintain records containing at least the following information:

(a) 

the breed, age, identification and health status of donor animals used for the production of germinal products;

(b) 

the time and place of collection, and the processing and storage, of germinal products collected, produced or processed;

(c) 

the identification of the germinal products together with details of their place of destination, if known;

(d) 

the documents required to accompany germinal products arriving at or leaving the establishment in question in accordance with Article 162 and Article 164(2) and any rules adopted 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 exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
3.  

Operators 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 competent authority on request;

(b) 

retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.

Article 104

Record-keeping obligations of transporters

1.  

Transporters shall keep and maintain records containing at least the following information:

(a) 

the establishments visited by them;

(b) 

the categories, species and number of kept terrestrial animals transported by them;

(c) 

the cleaning, disinfection and disinfestation of the means of transport used;

(d) 

details of the documents accompanying the animals in question, including their document numbers.

The records shall be kept and maintained in paper or electronic form.

2.  
Transporters presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
3.  

Transporters shall keep the records provided for in paragraphs 1 and 2:

(a) 

in such a manner that they can be made immediately available to the competent authority on request;

(b) 

for a minimum period to be prescribed by the competent authority, which may not be less than three years.

Article 105

Record-keeping obligations of operators conducting assembly operations

1.  

Operators 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, categories, numbers and identification of kept terrestrial animals under their responsibility;

(b) 

movements of kept terrestrial animals under their responsibility, stating as appropriate:

(i) 

their place of origin and destination;

(ii) 

the date of such movements;

(c) 

the documents required to accompany kept terrestrial 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 adopted pursuant to Articles 118 and 120 and points (b) and (c) of Article 144(1);

(d) 

mortality of kept terrestrial animals under their responsibility; and

(e) 

biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for the species and categories of kept terrestrial animals under their responsibility.

The records shall be kept and maintained in paper or electronic form.

2.  
Operators whose activities present a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
3.  

Operators shall:

(a) 

make the records referred to in paragraph 1 available to the competent authority on request;

(b) 

retain those records for a minimum period to be prescribed by the competent authority, which may not be less than three years.

Article 106

Delegation of powers concerning record-keeping

1.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules supplementing the record-keeping requirements provided for in Articles 102, 103, 104 and 105, as regards:

(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 collected, produced or processed in a germinal products establishment after that establishment ceased its activities.

2.  

When establishing the rules to be laid down in delegated acts as provided for in paragraph 1, the Commission shall base those rules on the following matters:

(a) 

the risks posed by each type of establishment or activity;

(b) 

the species and categories of kept terrestrial animals or germinal products in the establishment concerned, or transported to or from that establishment;

(c) 

the type of production on the establishment or the type of activity;

(d) 

the typical movement patterns and categories of the animals concerned;

(e) 

the number of kept terrestrial animals or volume of germinal products under the responsibility of the operator concerned.

Article 107

Implementing powers concerning exemptions from the record-keeping requirements

The Commission may, by means of implementing acts, lay down rules concerning the types of establishments and operators that may be exempted by Member States from the record-keeping requirements provided for in Articles 102, 103, 104 and 105, as regards:

(a) 

establishments keeping, or operators handling or transporting, a small number of kept terrestrial animals or a small volume or number of germinal products;

(b) 

species or categories of kept terrestrial animals or germinal products.

When adopting those implementing acts, the Commission shall base those acts on the criteria laid down in Article 106(2).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 2

Traceability requirements for kept terrestrial animals and germinal products



Section 1

Kept terrestrial animals

Article 108

Member States' responsibility for establishing a system for the identification and registration of kept terrestrial animals

1.  
Member States 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 adopted pursuant to it. Such a system shall, when appropriate, provide for the recording of the movements of such animals.
2.  

When establishing the system referred to in paragraph 1, Member States shall take into account:

(a) 

the species or categories of kept terrestrial animals concerned;

(b) 

the risk posed by that species or category.

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) 

identification documents, movement documents and other documents for identifying and tracing kept terrestrial animals as referred to in Article 110;

(c) 

up–to–date records in establishments as provided for in points (a) and (b) of Article 102(1);

(d) 

a computer 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 entry into the Union;

(c) 

ensures the efficient interoperability, integration and compatibility of the elements of that system;

(d) 

ensures that the system, to the extent appropriate, is adapted to:

(i) 

the computerised information system for Union notification and reporting provided for in Article 22;

(ii) 

TRACES;

(e) 

ensures a coherent approach in respect of the different animal species covered by the system.

5.  

Member States may when appropriate:

(a) 

use the whole or part of the system provided for in paragraph 1 for purposes other than those referred to in points (a) and (b) of paragraph 4;

(b) 

integrate the identification 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 adopted pursuant to points (b) and (c) of Article 144(1) and Article 151(3) and (4);

(c) 

designate another authority or authorise another body or a natural person to ensure the practical application of the identification and registration system provided for in paragraph 1 of this Article, including the issuing of identification 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 terrestrial animals

1.  

The Member States shall establish and maintain a computer database for the recording of at least:

(a) 

the following information related to kept animals of the bovine species:

(i) 

their individual identification as provided for in point (a) of Article 112;

(ii) 

the establishments keeping them;

(iii) 

their movements into and from those establishments;

(b) 

the following information related to kept animals of the ovine and caprine species:

(i) 

information on their identification 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 identification 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 identification provided for in point (b) of Article 114(1) linking the animal concerned with the identification document referred to in point (iii) where relevant;

(iii) 

the relevant identification details from the identification document provided for in point (c) of Article 114(1), as determined in the rules adopted pursuant to Articles 118 and 120;

(iv) 

the establishments where those animals are habitually kept;

(e) 

information related 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 adopted pursuant to paragraph 2.

2.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning 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 computer database provided for in that paragraph where necessary, due to the specific 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 terrestrial animals, their movements between Member States and their entry into the Union.

Article 110

Obligation of the competent authority in respect of identification documents, movement documents and other documents for the identification and tracing of kept terrestrial animals

1.  

Each competent authority shall:

(a) 

issue identification documents in respect of kept terrestrial animals where those documents are required by point (c) of Article 114(1) and point (b) of Article 117 and by rules adopted pursuant to Articles 118 and 120;

(b) 

issue identification documents in respect of bovine animals as required by point (b) of Article 112, unless Member States exchange electronic data with other Member States within the framework 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 identification 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 adopted pursuant to Articles 118 and 120.

2.  
Point (b) of paragraph (1) is without prejudice to the right of Member States to adopt national rules on the issuing of passports for animals not intended for movement between Member States.

Article 111

Public availability of information on means of identification

Each competent authority shall inform the Commission of, and make publicly available, information on:

(a) 

contact points for the computer databases established by the Member States in accordance with Article 109(1);

(b) 

the authorities or bodies responsible for issuing identification documents, movement documents and other documents in accordance with Article 110, taking into account point (c) of Article 108(5);

(c) 

the means of identification that are to be used for each species and category of kept terrestrial 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 adopted pursuant to Articles 118 and 120;

(d) 

the prescribed format for the issuing of the identification documents and other documents referred to in Article 110.

Article 112

Operators' obligations in respect of the identification of kept animals of the bovine species

Operators keeping animals of the bovine species shall:

(a) 

ensure that those kept animals are identified individually by a physical means of identification;

(b) 

ensure that those kept animals, when they are moved between Member States, are issued with an identification document from the competent authority or designated authority or authorised body of origin, unless the conditions laid down in point (b) of Article 110(1) are met;

(c) 

ensure that that identification document:

(i) 

is kept, correctly completed and updated by the operator concerned; 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 concerned, and all births and deaths in that establishment, to the computer database provided for in Article 109(1).

Article 113

Operators' obligations in respect of the identification of kept animals of the ovine and caprine species

1.  

Operators keeping kept animals of the ovine and caprine species shall:

(a) 

ensure that those kept animals are each identified by a physical means of identification;

(b) 

ensure that those kept animals are accompanied by a correctly completed movement document based on the model drawn up by the competent authority in accordance with Article 110 when they are moved from the establishment keeping those animals within the Member State concerned;

(c) 

transmit the information on movements of those kept animals from and to the establishment to the computer database provided for in Article 109(1).

2.  

Member States may exempt operators from the requirement to ensure that kept animals of the ovine and caprine 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 computer database provided for in Article 109(1);

(b) 

the system for the identification and registration of kept animals of the ovine and caprine species provides level of traceability equivalent to that provided by movement documents.

Article 114

Operators' obligations in respect of the identification and registration of kept animals of the equine species

1.  

Operators keeping kept animals of the equine species shall ensure that those animals are individually identified by:

(a) 

a unique code which is recorded in the computer database provided for in Article 109(1);

(b) 

a physical means of identification or other method which unequivocally links the kept animal with the identification document provided for in point (c) of this paragraph and issued by the competent authority in accordance with Article 110;

(c) 

a correctly completed single lifetime identification document.

2.  
Operators of kept animals of the equine species shall ensure that the information on those animals is transmitted to the computer database provided for in Article 109(1).

Article 115

Operators' obligations in respect of the identification and registration of kept animals of the porcine species

Operators keeping kept animals of the porcine species shall:

(a) 

ensure that those kept animals are each identified by a physical means of identification;

(b) 

ensure that those kept animals are accompanied by a correctly completed movement document based on the model drawn up by the competent authority in accordance with point (b) of Article 110(1) when they are moved from the establishment keeping those animals within the Member State concerned;

(c) 

transmit the information relating to the establishment keeping those animals to the computer database provided for in Article 109(1).

Article 116

Derogations concerning movements of kept animals of the porcine species

By way of derogation from point (b) of Article 115, Member States may exempt operators from the requirement to ensure that kept animals of the porcine species are accompanied by correctly completed movement documents based on the model drawn up by the competent authority for movements within the Member State concerned, provided that:

(a) 

the information contained in such movement documents is included in the computer database established by that Member State in accordance with Article 109(1);

(b) 

the system for the identification and registration of kept terrestrial animals of the porcine species provides a level of traceability equivalent to that provided by such movement documents.

Article 117

Operators' obligation in respect of the identification of kept terrestrial animals other than animals of the bovine, ovine, caprine, porcine and equine species

Operators shall ensure that kept terrestrial animals of species other than those of the bovine, ovine, caprine, porcine and equine species fulfil the following requirements, when required by the rules adopted pursuant to Articles 118 and 120:

(a) 

they are identified, either individually or in groups;

(b) 

they are accompanied by correctly completed and updated identification documents, movement documents or other documents for the identification and tracing of animals, as appropriate for the animal species concerned.

Article 118

Delegation of powers concerning identification and registration

1.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

detailed requirements for the means and methods of identification of kept terrestrial 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 computer 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 exchange of electronic data between computer databases of Member States as referred to in point (b) of Article 110(1).

2.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

detailed requirements for alternative means and methods of identification to those referred to in point (a) of paragraph 1 of this Article, as well as exemptions and special provisions for certain categories of animals or circumstances and conditions for such exemptions;

(b) 

specific provisions for the identification 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 accompany animals when they are moved;

(c) 

detailed requirements for the identification and registration of kept terrestrial animals of species other than the bovine, ovine, caprine, porcine and equine species where necessary, taking into account the risks posed by the species concerned, in order to:

(i) 

ensure the efficient application of the disease prevention and control measures provided for in this Regulation;

(ii) 

facilitate the traceability of kept terrestrial animals, and their movements within and between Member States and their entry into the Union;

(d) 

rules on the information to be included in:

(i) 

the computer databases provided for in point (e) of Article 109(1);

(ii) 

the identification and movement documents provided for in point (b) of Article 117;

(e) 

rules on the identification and registration of kept terrestrial animals as referred to in Articles 112 to 117 after their entry into the Union.

3.  
When establishing the rules to be laid down in the delegated 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 concerning derogations from the traceability requirements

1.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations for operators 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 necessary 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 compromised,

as well as transitional measures required for the practical application of such derogations.

2.  

When establishing the rules to be laid down in the delegated acts provided for in paragraph 1, the Commission shall base those rules on the following considerations:

(a) 

the species and categories of kept terrestrial animals concerned;

(b) 

the risks involved for those kept terrestrial animals;

(c) 

the number of animals in the establishments concerned;

(d) 

the type of production in the establishments where those terrestrial animals are kept;

(e) 

movement patterns for the species and categories of kept terrestrial animals concerned;

(f) 

considerations concerning the protection and conservation of the species of kept terrestrial animals concerned;

(g) 

the performance of the other traceability elements of the system for the identification and registration of kept terrestrial animals referred to in Article 108(3).

Article 120

Implementing powers concerning the traceability of kept terrestrial animals

1.  

The Commission shall, by means of implementing acts, adopt rules:

(a) 

for uniform access to data contained in, and the technical specifications and operational rules of, the computer databases referred to in points (a) to (d) of Article 109(1);

(b) 

on the technical conditions and modalities for the exchange of electronic data between computer databases of Member States and the recognition of full operability of the data exchange systems referred to in point (b) of Article 110(1).

2.  

The Commission may, by means of implementing acts, adopt rules:

(a) 

for the uniform application of the identification and registration system provided for in Article 108(1) for different species or categories of kept terrestrial animals, in order to ensure its efficient operation;

(b) 

for the uniform application of point (c) of Article 108(5) concerning the authorised bodies or natural persons referred 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 identification, including:

(i) 

the time periods for the application of the means and methods of identification;

(ii) 

the removal, modification or replacement of the means and methods of identification and the deadlines for such operations; and

(iii) 

the configuration of the identification code;

(d) 

on the technical specifications, 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 uniform access to data contained in, and the technical specifications and operational rules of, the computer databases referred to in point (e) of Article 109(1);

(f) 

on the deadlines, obligations and procedures for the transmission of information by operators or other natural or legal persons and for the registration of kept terrestrial animals in the computer databases;

(g) 

on guidelines and procedures for electronic identification of animals, where relevant;

(h) 

on the practical application of exemptions from the identification and registration requirements provided for in the rules adopted pursuant to Article 119(1).

3.  
The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).



Section 2

Germinal products

Article 121

Traceability requirements for germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species

1.  

Operators producing, processing or storing germinal products shall mark germinal products of kept animals of the bovine, caprine, 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 collected, produced, processed and stored.

2.  

The marking provided for in paragraph 1 shall be designed in such a way as to ensure:

(a) 

the efficient application of the disease prevention and control measures provided for in this Regulation;

(b) 

the traceability of the germinal products, their movements within and between Member States and their entry into the Union.

Article 122

Delegation of powers concerning traceability requirements for germinal products

1.  
The Commission shall adopt delegated acts in accordance with Article 264 concerning traceability requirements for germinal products of kept terrestrial animals of the bovine, caprine, ovine, porcine and equine species supplementing the rules laid down in Article 121;
2.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning traceability requirements for germinal products of kept terrestrial animals of species other than of the bovine, caprine, ovine, porcine and equine species, where necessary for:

(a) 

the efficient application of the disease prevention and control measures provided for in this Regulation;

(b) 

the traceability of those germinal products, their movements within and between Member States and their entry into the Union.

3.  

When adopting the delegated acts provided for in paragraph 1, the Commission shall base those acts on the following matters:

(a) 

the species of kept terrestrial animals from which the germinal products originate;

(b) 

the health status of donor animals;

(c) 

the risk involved with such germinal products;

(d) 

the type of germinal products;

(e) 

the type of collection, production, processing or storage of germinal products;

(f) 

the movement patterns for the relevant species and categories of kept terrestrial animals and their germinal products;

(g) 

considerations concerning the protection and conservation of species of kept terrestrial animals;

(h) 

other elements that may contribute to the traceability of germinal products.

Article 123

Implementing powers concerning traceability requirements for germinal products

The Commission shall, by means of implementing acts, lay down rules concerning:

(a) 

technical requirements and specifications for marking as provided for in Article 121(1);

(b) 

operational requirements for the traceability provided for in delegated acts adopted pursuant to Article 122(1).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 3

Movements within the Union of kept terrestrial animals



Section 1

General requirements for movements

Article 124

General requirements for movements of kept terrestrial animals

1.  

Operators shall take appropriate preventive measures to ensure that the movement of kept terrestrial animals does not jeopardise the health status at the place of destination with regard to:

(a) 

the listed diseases referred to in point (d) of Article 9(1);

(b) 

emerging diseases.

2.  

Operators 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) 

registered by the competent authority in accordance with Article 93; or

(ii) 

approved by the competent authority in accordance with Articles 97(1) and 98, when required by Article 94(1) or Article 95; or

(iii) 

granted a derogation from the registration requirement laid down in Article 84;

(b) 

they fulfil the identification and registration requirements laid down in Articles 112, 113, 114, 115 and 117 and the rules adopted pursuant to Articles 118 and 120.

Article 125

Disease prevention measures in relation to transport

1.  

Operators shall take the appropriate and necessary preventive measures to ensure that:

(a) 

the health status of kept terrestrial animals is not jeopardised during transport;

(b) 

transport operations of kept terrestrial animals do not cause the potential spread of listed diseases as referred 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 transport and other adequate biosecurity measures are taken, as appropriate to the risks involved with the transport operations concerned.

2.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

the conditions and requirements for cleaning and disinfection of, and control of insects and rodents with respect to, equipment and means of transport and the use of biocidal products for those purposes;

(b) 

other appropriate biosecurity measures as provided for in point (c) of paragraph 1 of this Article.



Section 2

Movements between Member States

Article 126

General requirements for movements of kept terrestrial animals between Member States

1.  

Operators shall only move kept terrestrial animals to another Member State if the animals in question fulfil the following conditions:

(a) 

they show no disease symptoms;

(b) 

they come from a registered or approved establishment:

(i) 

where there are no abnormal mortalities with an undetermined cause;

(ii) 

which is not subject to movement restrictions affecting the species to be moved in accordance with the rules laid down in 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 adopted 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 adopted pursuant to Article 259, unless derogations from movement restrictions have been granted in accordance with those rules;

(iii) 

which is not situated in a restricted 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 adopted 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 adopted pursuant to Article 259, unless derogations have been granted in accordance with those rules;

(c) 

they have not been in contact with kept terrestrial animals which are subject to movement restrictions as referred to in point (b)(ii) and (iii) or kept terrestrial animals of a listed species of a lower health status, for an adequate period of time prior to the date of the intended movement to another Member State, thereby minimising the possibility of spreading disease, taking into account the following matters:

(i) 

the incubation period and routes of transmission of the listed diseases and emerging diseases in question;

(ii) 

the type of establishment concerned;

(iii) 

the species and category of kept terrestrial animals moved;

(iv) 

other epidemiological factors;

(d) 

they fulfil the relevant requirements provided for in Sections 3 to 8 (Articles 130 to 154).

2.  
Operators shall take all necessary measures to ensure that kept terrestrial animals moved to another Member State are consigned directly to their place of destination in that other Member State unless they need to stop at a place of resting for animal welfare reasons.

Article 127

Obligations of operators at the place of destination

1.  

Operators of establishments and slaughterhouses receiving kept terrestrial animals from another Member State shall:

(a) 

check that:

(i) 

the means or methods of identification 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 adopted 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 adopted pursuant to Articles 118 and 120 are in place and are correctly completed;

(b) 

check that the animal health certificates provided for in Article 143 and in any rules adopted pursuant to points (b) and (c) of Article 144(1) or the self–declaration documents provided for in Article 151 and the rules adopted pursuant to Article 151(3) and (4) are in place;

(c) 

inform the competent authority of the place of destination, after checking the kept terrestrial animals received, of any irregularity with regard to:

(i) 

the kept terrestrial animals received;

(ii) 

the means or methods of identification referred to in point (a)(i);

(iii) 

the documents referred to in points (a)(ii) and (b).

2.  
In the event of any irregularity as referred to in point (c) of paragraph 1, the operator shall isolate the animals concerned by that irregularity until the competent authority of the place of destination has taken a decision regarding them.

Article 128

Prohibition on movements of kept terrestrial animals for disease eradication purposes outside the territory of a Member State

Operators 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 authorise the movement in advance.

Article 129

General requirement applicable to operators in respect of movements of kept terrestrial animals passing through Member States but intended for export from the Union to third countries or territories

Operators shall ensure that kept terrestrial animals intended for export to a third country or territory and passing through the territory of another Member State fulfil the requirements laid down in Articles 124, 125, 126 and 128.



Section 3

Specific requirements in respect of movements to other Member States of ungulates and poultry

Article 130

Movements of kept ungulates and poultry to other Member States

Operators shall only move kept ungulates and poultry from an establishment in one Member State to another Member State if the animals in question fulfil the following conditions as regards the listed diseases referred to in point (d) of Article 9(1):

(a) 

they show no clinical symptoms or signs of listed 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 appropriate to those listed diseases, taking into account the species and category of kept ungulates and poultry to be moved;

(c) 

for a period of time appropriate for those listed diseases and the species and category of ungulates or poultry to be moved, no kept ungulates or poultry have been introduced into the establishment of origin when a requirement to that effect is laid down in the rules adopted in accordance with Article 131 or Article 135;

(d) 

they are presumed not to pose a significant risk of spreading of those listed diseases at the place of destination, based on:

(i) 

the health status concerning relevant diseases for species or categories of kept ungulates and poultry moved, taking into account the health status at the place of destination;

(ii) 

the results of laboratory or other examinations necessary in order to provide guarantees regarding the health status required for the movement in question;

(iii) 

the application of vaccination or other disease prevention or risk-mitigation 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 poultry to other Member States

1.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

residency periods as referred to in point (b) of Article 130;

(b) 

the period of time necessary in order to limit the introduction of kept ungulates or poultry into establishments prior to movement as provided for in point (c) of Article 130;

(c) 

supplementary requirements to ensure that kept ungulates and poultry do not pose a significant 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 necessary risk-mitigation measures supplementing the requirements laid down in Article 130.

2.  

When establishing the rules to be laid down in the delegated 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 category of kept ungulates or poultry to be moved;

(b) 

the health status as regards listed diseases referred to in point (d) of Article 9(1) in the establishments, compartments, zones and Member States of origin and destination;

(c) 

the type of establishment concerned and the type of production at the places of origin and destination;

(d) 

the type of movement concerned;

(e) 

the species and categories of kept ungulates or poultry to be moved;

(f) 

the age of the kept ungulates or poultry to be moved;

(g) 

other epidemiological factors.

Article 132

Kept ungulates and poultry moved to another Member State and intended for slaughter

1.  
Operators of slaughterhouses receiving kept ungulates and poultry from another Member State shall slaughter those animals as soon as possible following their arrival and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to paragraph 2.
2.  
The Commission shall adopt delegated acts in accordance with Article 264 concerning the time of slaughter provided for in paragraph 1 of this Article.



Section 4

Assembly operations in respect of kept ungulates and poultry

Article 133

Derogation in respect of assembly operations

1.  
By way of derogation from Article 126(2), operators may subject kept ungulates and poultry 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 approved 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 transport, collecting kept ungulates or poultry 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 approved for that purpose in accordance with Article 97(1) and Article 99(4) and (5).

Article 134

Disease prevention requirements in respect of assembly operations

Operators conducting assembly operations shall ensure that:

(a) 

the kept ungulates and poultry 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 poultry are assembled and moved to their final place of destination in another Member State as soon as possible after leaving their establishment of origin, and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to point (c) of Article 135;

(c) 

the necessary biosecurity measures are taken to ensure that the kept ungulates and poultry assembled:

(i) 

do not come into contact with kept ungulates or poultry having a lower health status;

(ii) 

do not pose a significant risk for the spread of the listed diseases referred to in point (d) of Article 9(1) to the kept ungulates or poultry at the place where the assembly operation takes place;

(d) 

the kept ungulates and poultry are identified where so required by this Regulation and are accompanied by the following documents:

(i) 

the identification 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 adopted 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 derogations are provided for in the rules adopted pursuant to point (a) of Article 144(1);

(iii) 

the self–declaration document as provided for in Article 151.

Article 135

Delegation of powers concerning assembly operations

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

specific rules for assembly operations, where other risk-mitigation measures, in addition to those provided for in points (b) and (c) of Article 134, are in place;

(b) 

criteria under which Member States of origin may allow assembly operations to take place on means of transport, as provided for in the second subparagraph of Article 133(2);

(c) 

the timeframe between the time of departure of the kept ungulates or poultry from their establishment of origin and their departure from the assembly operation to their final destination in another Member State, as referred to in point (b) of Article 134;

(d) 

detailed rules as regards the biosecurity measures provided for in point (c) of Article 134.



Section 5

Movements to other Member States of kept terrestrial animals other than kept ungulates and poultry

Article 136

Movements of kept terrestrial animals other than kept ungulates and poultry to other Member States and delegated acts

1.  
Operators shall only move kept terrestrial animals other than kept ungulates or poultry from an establishment in one Member State to another Member State if the animals in question do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) at the place of destination.
2.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules to ensure that kept terrestrial animals other than kept ungulates or poultry do not pose a significant risk for the spread of listed diseases as referred 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 delegated 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 category of kept terrestrial animals to be moved;

(b) 

the health status as regards the listed diseases referred to in point (d) of Article 9(1) in the establishments, compartments, zones and Member States of origin and the place of destination;

(c) 

the types of establishment and the types of production at the place of origin and the place of destination;

(d) 

the types of movement in respect of the final use of animals at the place of destination;

(e) 

the species and categories of kept terrestrial animals to be moved;

(f) 

the age of the kept terrestrial animals to be moved;

(g) 

other epidemiological factors.



Section 6

DErogating from, and supplementing, risk-mitigation measures for movements of kept terrestrial animals

Article 137

Kept terrestrial animals intended for confined establishments and delegated acts

1.  

Operators shall only move kept terrestrial animals to a confined 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 listed diseases as referred to in point (d) of Article 9(1) to listed species or to categories of animals at the confined establishment of destination, except where the movement in question is authorised for scientific purposes.

2.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

detailed rules for movements of kept terrestrial animals into confined establishments in addition to those provided for in paragraph 1 of this Article;

(b) 

specific rules for movements of kept terrestrial animals into confined establishments where the risk-mitigation measures in place guarantee that such movements do not pose a significant risk for the health of kept terrestrial animals within that confined establishment and the surrounding establishments.

Article 138

Movements of kept terrestrial animals for scientific purposes and delegated acts

1.  
The competent authority of the place of destination may, subject to the agreement of the competent authority of the place of origin, authorise movements of kept terrestrial animals into the territory of the Member State of destination, for scientific purposes, where those movements do not comply with the requirements of Sections 1 to 5 (Articles 124 to 136), with the exception of Articles 124 and 125, point (b)(ii) of Article 126(1) and Article 127.
2.  

The competent authority of the place of destination shall only grant derogations as provided for in paragraph 1 under the following conditions:

(a) 

the competent authorities of the places of destination and origin:

(i) 

have agreed on the conditions for such movements;

(ii) 

ensure that the necessary risk-mitigation measures are in place so that those movements do not jeopardise the health status in places en route and in the place of destination with regard to the listed diseases referred to in point (d) of Article 9(1); and

(iii) 

have notified, where relevant, the competent authorities of the Member States of passage of the derogation granted and of the conditions under which it is granted; and

(b) 

those movements of those animals take place under the supervision of the competent authorities of the places of origin and destination, and where relevant, the competent authorities of the Member States of passage.

3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules for the granting of derogations by competent authorities, supplementing those provided for in paragraphs 1 and 2 of this Article.

Article 139

Derogations concerning recreational use, sporting and cultural events, work near borders and grazing

1.  

The competent authority of the place of destination may grant derogations from the requirements of Sections 2 to 5 (Articles 126 to 136), with the exception of points (a),(b) and (c) of Article 126(1) and Articles 127 and 128, for intra–Union movements of kept terrestrial animals between Member States where such movements are for:

(a) 

recreational use near borders;

(b) 

exhibitions, and sporting, cultural and similar events, organised near borders;

(c) 

grazing of kept terrestrial animals in grazing areas shared between Member States; or

(d) 

work done by kept terrestrial animals near borders of Member States.

2.  
Derogations by the competent authority of the place of destination for movements of kept terrestrial animals for the purposes provided for in paragraph 1 shall be agreed on between the Member States of origin and destination and appropriate risk-mitigation measures shall be taken to ensure that such movements do not pose a significant risk.
3.  
The Member States referred to in paragraph 2 shall inform the Commission of the granting of derogations as provided for in paragraph 1.
4.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules for the granting of derogations by the competent authority of the place of destination, supplementing those provided for in paragraph 1 of this Article.

Article 140

Delegation of power concerning circuses, exhibitions, sporting events and recreational use, zoos, pet shops, animal shelters and wholesalers

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

specific requirements supplementing the rules laid down in Sections 2 to 5 (Articles 126 to 136) for movements of kept terrestrial animals for the following purposes:

(i) 

circuses, zoos, pet shops, animal shelters and wholesalers;

(ii) 

exhibitions and sporting, cultural and similar events;

(b) 

derogations from Sections 2 to 5 (Articles 126 to 136), with the exception of points (a), (b) and (c) of Article 126(1) and Articles 127 and 128, for movements of kept terrestrial animals as referred to in point (a) of this Article.

Article 141

Implementing power to adopt temporary rules for movements of specific species or categories of kept terrestrial animals

1.  

The Commission may, by means of implementing acts, lay down temporary rules, by way of addition or alternative to those laid down in this Chapter, for movements of specific species or categories of kept terrestrial animals where:

(a) 

the movement requirements provided for in Article 130, Article 132(1), Articles 133 and 134, Articles 136(1), 137(1) and 138(1) and (2) and Article 139 and the rules adopted 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 mitigating the risks posed by the movement of such animals; or

(b) 

a listed disease as referred 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 adopted in accordance with the examination procedure referred to in Article 266(2).

2.  
On duly justified imperative grounds of urgency relating to diseases representing a risk of a highly significant impact and taking into account the matters referred to in Article 142, the Commission shall adopt immediately 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 delegated and implementing 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 referred to in those provisions;

(b) 

the health status as regards the listed diseases referred to in point (d) of Article 9(1) at the places of origin, passage and destination;

(c) 

listed animal species for the listed diseases referred to in point (d) of Article 9(1);

(d) 

biosecurity 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) 

specific movement patterns of the type of establishment and the species and category of kept terrestrial animals concerned;

(g) 

other epidemiological factors.



Section 7

Animal health certification

Article 143

Obligation of operators to ensure that animals are accompanied by an animal health certificate

1.  

Operators shall only move the following species and categories of kept terrestrial animals to another Member State if the animals in question are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 149(1):

(a) 

ungulates;

(b) 

poultry;

(c) 

kept terrestrial animals other than ungulates and poultry, intended for a confined establishment;

(d) 

kept terrestrial animals other than those referred to in points (a), (b) and (c) of this paragraph, when required in accordance with delegated acts adopted pursuant to point (c) of Article 144(1).

2.  
In cases where kept terrestrial animals are allowed to leave a restricted 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 adopted 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, operators shall only move such kept terrestrial animals within a Member State or from one Member State to another Member State when the animals to be moved are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 149(1).

The competent authority 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 authority considers that an alternative system is in place ensuring that the consignment of such animals is traceable and that those animals fulfil the animal health requirements for such movement.

3.  
Operators shall take all necessary measures to ensure that the animal health certificate referred to in paragraph 1 of this Article accompanies the kept terrestrial animals from their place of origin to their final place of destination, unless specific measures are provided for in rules adopted pursuant to Article 147.

Article 144

Delegation of powers concerning the obligation of operators to ensure that animals are accompanied by an animal health certificate

1.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

derogations from the animal health certification requirements provided for in Article 143(1), for movements of kept terrestrial animals which do not pose a significant risk for the spread of a disease on account of:

(i) 

the species or categories of the kept terrestrial animals that are being moved and the listed diseases referred to in point (d) of Article 9(1) for which they are listed species;

(ii) 

the methods of keeping and the type of production of those species and categories of kept terrestrial animals;

(iii) 

the intended use of the kept terrestrial animals; or

(iv) 

the place of destination of the kept terrestrial 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-mitigation measures concerning surveillance or biosecurity are taken, taking into account the matters provided for in paragraph 2 of this Article, which ensure:

(i) 

the traceability of the kept terrestrial animals being moved;

(ii) 

that the kept terrestrial animals being moved 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 categories 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 imperative in order to ensure that the movement in question complies with the animal health requirements for movements provided for in Sections 1 to 6 (Articles 124 to 142).

2.  

When establishing the special rules provided for in point (b) of paragraph 1, the Commission shall take the following matters into account:

(a) 

the assessment by the competent authority of the biosecurity put in place by operators as provided for in point (b) of Article 10(1) and any rules adopted pursuant Article 10(6);

(b) 

the ability of the competent authority, in so far as may be necessary and appropriate, to take measures and to engage in activities required by this Regulation as provided for in Article 13(1);

(c) 

the level of knowledge 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 performance by the competent authority of its obligations under the Union notification and reporting system provided for in Articles 19 to 22 and in the rules adopted 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 adopted pursuant to Articles 29 and 30.

3.  
The Commission shall take the matters referred to in point (a)(i) to (iv) of paragraph 1 into account when establishing the requirements for animal health certification 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 concerned;

(b) 

the means of transport and the transporter;

(c) 

a description of the kept terrestrial animals;

(d) 

the number of kept terrestrial animals;

(e) 

the identification and registration of kept terrestrial animals, where required by Articles 112, 113, 114, 115 and 117 and by any rules adopted 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 terrestrial 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 concerning the content of animal health certificates

1.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

detailed rules on the content of animal health certificates as provided for in Article 145(1) for different species and categories of kept terrestrial animals and for specific types of movements as provided for in the rules adopted pursuant to Article 147;

(b) 

additional information to be contained in the animal health certificate provided for in Article 145(1).

2.  
The Commission may, by means of implementing acts, lay down rules for model forms of animal health certificates. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 147

Delegation of powers concerning specific types of movements of kept terrestrial animals

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning specific measures derogating from, or supplementing, the obligation of operators to ensure that animals are accompanied by an animal health certificate as provided for in Article 143 and in the rules adopted pursuant to Article 144, for the following types of movements of kept terrestrial animals:

(a) 

movements of kept ungulates and poultry passing through the assembly operations provided for in Article 133 prior to reaching their final place of destination;

(b) 

movements of kept terrestrial animals which are required to return to their place of origin or to be moved to a different destination, for one or more of the following reasons:

(i) 

their intended journey was unexpectedly interrupted for animal welfare reasons;

(ii) 

unforeseen accidents or events during the journey;

(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 country or territory;

(c) 

movements of kept terrestrial animals intended for exhibitions, and sporting, cultural and similar events, and their subsequent return to their place of origin.

Article 148

Operators' obligations to cooperate with the competent authority for the purposes of animal health certification

Operators shall:

(a) 

provide the competent authority with all the information necessary to complete the animal health certificate provided for in Article 143(1) and (2) and in any rules adopted pursuant to Article 146(1) or Article 147, in advance of the intended movement;

(b) 

where necessary, ensure that the kept terrestrial animals in question are subjected to documentary, identity and physical checks as provided for in Article 149(3).

Article 149

Responsibility of the competent authority for animal health certification

1.  

The competent authority shall, upon request by an operator, issue an animal health certificate for the movement of kept terrestrial animals, where required by Article 143 or by delegated acts adopted pursuant to Article 144(1), provided that the following movement requirements have been complied 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;

▼C1

(b) 

those provided for in delegated acts adopted pursuant to Articles 125(2) and 131(1), Article 135, Articles 136(2), 137(2), 138(3) and 139(4) and Article 140;

▼B

(c) 

those provided for in implementing acts adopted pursuant to Article 141.

2.  

Animal health certificates shall:

(a) 

be verified, stamped and signed by an official veterinarian;

(b) 

remain valid for the period of time provided for in the rules adopted pursuant to point (c) of paragraph 4, during which the kept terrestrial animals covered by it continue to fulfil the animal health guarantees contained in it.

3.  
Before signing an animal health certificate, the official veterinarian concerned shall verify, by means of documentary, identity and physical checks as provided for by delegated acts adopted pursuant to paragraph 4, that the kept terrestrial animals covered by it fulfil the requirements of this Chapter.
4.  

The Commission shall adopt delegated acts in accordance with Article 264 laying down rules concerning:

(a) 

the types of documentary, identity and physical checks and examinations in relation to different species and categories of kept terrestrial animals that must be carried out by the official veterinarian in accordance with paragraph 3 in order to verify compliance with the requirements of this Chapter;

(b) 

the timeframes for the carrying-out of such documentary, identity and physical checks and examinations and the issuing of animal health certificates by the official veterinarian prior to the movement of consignments of kept terrestrial animals;

(c) 

the duration of the validity of animal health certificates.

Article 150

Electronic animal health certificates

Electronic animal health certificates, produced, handled and transmitted by means of Traces, may replace accompanying 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 adopted 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 competent authorities of the Member States of origin, passage and destination are able to have access to the electronic documents at all times during the transport.

Article 151

Self–declaration by operators for movements to other Member States

1.  
Operators at the place of origin shall issue a self–declaration document for movements of kept terrestrial animals from their place of origin in one Member State to their place of destination in another Member State, and shall ensure that it accompanies such animals, where they are not required to be accompanied 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 concerning 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 transport and the transporter;

(c) 

a description of the kept terrestrial animals, their species, category and quantity;

(d) 

identification and registration where required in accordance with Articles 112, 113, 114 and 115, point (a) of Article 117 and any rules adopted 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 empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

detailed rules on the content of the self–declaration document provided for in paragraph 2 of this Article for different species and categories of animals;

(b) 

information to be contained in the self–declaration document in addition to that provided for in paragraph 2 of this Article.

4.  
The Commission may, by means of implementing acts, lay down rules for the model forms of the self–declaration document provided for in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



Section 8

Notification of movements of kept terrestrial animals to other Member States

Article 152

Obligation of operators concerning the notification of movements of kept terrestrial animals to other Member States

Operators other than transporters shall notify the competent authority in their Member State of origin in advance of intended movements of kept terrestrial animals from that Member State to another Member State where:

(a) 

the animals must be accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Articles 149 and 150 and any rules adopted pursuant to Article 149(4);

(b) 

the animals must be accompanied by an animal health certificate for kept terrestrial animals where they are being moved from a restricted zone and are subject to disease control measures as referred to in Article 143(2);

(c) 

the animals are granted a derogation from the animal health certification 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) 

notification is required in accordance with delegated acts adopted pursuant to Article 154(1).

For the purposes of the first paragraph of this Article, operators shall provide the competent authority of their Member State of origin with all the necessary information to enable it to notify the movements of the kept terrestrial animals to the competent authority of the Member State of destination in accordance with Article 153(1).

Article 153

Responsibility of the competent authority to notify movements to other Member States

1.  
The competent authority of the Member State of origin shall notify the competent authority of the Member State of destination of movements of kept terrestrial animals as referred to in Article 152.
2.  
The notification referred to in paragraph 1 shall be carried out prior to the movement in question and, whenever possible, through Traces.
3.  
Member States shall designate regions for the management of notifications of movements as provided for in paragraph 1.
4.  
By way of derogation from paragraph 1, the competent authority of the Member State of origin may authorise the operator concerned to notify, partially or completely, movements of kept terrestrial animals through Traces to the competent authority of the Member State of destination.

Article 154

Delegation of power and implementing acts for the notification of movements by operators and by the competent authority

1.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

the requirement for advance notification by operators, in accordance with Article 152, of movements between Member States of kept terrestrial animals of species or categories other than those referred to in points (a) and (b) of that Article, where traceability of such movements of those species or categories is necessary in order to ensure compliance 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 emergency procedures for the notification of movements of kept terrestrial animals in the event of power cuts and other disturbances of Traces;

(d) 

the requirements for the designation of regions by Member States for the management of notifications of movements, as provided for in Article 153(3).

2.  

The Commission may, by means of implementing acts, lay down rules concerning:

(a) 

the details concerning notifications of movements of kept terrestrial animals by:

(i) 

operators to the competent authority of their Member State of origin in accordance with Article 152;

(ii) 

the competent authority 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 operator of the necessary information referred to in Article 152 to the competent authority of the Member State of origin;

(ii) 

the notification of movements of kept terrestrial animals by the competent authority of the Member State of origin as referred to in Article 153(1).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 4

Movements of wild terrestrial animals

Article 155

Wild terrestrial animals

1.  

Operators 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 significant 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;

(b) 

the wild animals do not come from a habitat in a restricted zone which is subject to movement restrictions concerning the animal species to which they belong due to the occurrence of a listed disease as referred to in point (d) of Article 9(1) or of an emerging disease, as provided for in Article 70(2) and in any rules adopted 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 adopted pursuant to Article 259, unless derogations have been granted in accordance with those rules;

(c) 

the wild animals are accompanied by an animal health certificate or other documents where animal health certification is necessary 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 adopted pursuant to points (c) and (d) of Article 156(1);

(d) 

the movements are notified by the competent authority of the Member State of origin to the competent authority of the Member State of destination, where animal health certification is required by the rules adopted pursuant to point (c) of Article 156(1); and

(e) 

the competent authority of the Member State of origin and the competent authority of the Member State of destination have agreed to such movement.

2.  
When animal health certification is required by the rules adopted 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 adopted 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 delegated acts adopted pursuant to Article 154(1) shall apply to movements of wild terrestrial animals.

Article 156

Empowerments concerning the movement of wild terrestrial animals

1.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(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 terrestrial animals for which, or the situations in which, an animal health certificate or other document is required to accompany such movements, and the requirements concerning the contents of such certificates or other documents;

(d) 

the notification by the competent authority of the Member State of origin to the competent authority of the Member State of destination in the case of movements of wild terrestrial animals between Member States, and the information to be included in such notification.

2.  

The Commission may, by means of implementing acts, lay down rules specifying the requirements provided for in Article 155 and in the delegated acts adopted pursuant to paragraph 1 of this Article, concerning:

(a) 

model forms of animal health certificates and other documents which are required to accompany movements of wild terrestrial animals, when provided for in delegated acts adopted pursuant to point (c) of paragraph 1 of this Article;

(b) 

the details of the notification to be given by the competent authority of the Member State of origin and the deadlines for such notifications, when provided for in rules adopted pursuant to point (d) of paragraph 1 of this Article.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 5

Movements within the Union of germinal products



Section 1

General requirements

Article 157

General requirements for movements of germinal products

1.  

Operators shall take appropriate preventive measures to ensure that movements of germinal products do not jeopardise the health status of kept terrestrial animals at the place of destination with regard to:

(a) 

the listed diseases referred to in point (d) of Article 9(1);

(b) 

emerging diseases.

2.  

Operators 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 competent authority in accordance with point (a) of the first paragraph of Article 93 and no derogation has been granted by the Member State of origin in accordance with Article 85;

(ii) 

approved by the competent authority in accordance with Article 97(1), when such approval is required by Article 94(1) or Article 95;

(b) 

they fulfil the traceability requirements of Article 121(1) and any rules adopted pursuant to Article 122(1).

3.  
Operators shall comply with the requirements of Article 125 for the transport of germinal products of kept terrestrial animals.
4.  
Operators shall not move germinal products from an establishment in one Member State to an establishment in another Member State unless the competent authority of the Member State of destination gives its express authorisation for such movement, where those germinal products are required to be destroyed for disease eradication purposes as part of an eradication programme as provided for in Article 31(1) or (2).

Article 158

Obligations for operators at the place of destination

1.  

Operators of establishments at the place of destination receiving germinal products from an establishment in another Member State shall:

(a) 

check for the presence of:

(i) 

marks in accordance with Article 121 and with rules adopted pursuant to Article 122;

(ii) 

animal health certificates as provided for in Article 161;

(b) 

after checking the germinal products received, inform the competent authority of the place of destination of any irregularity with regard to;

(i) 

the germinal products received;

(ii) 

the marks referred to in point (a)(i);

(iii) 

the animal health certificates referred to in point (a)(ii).

2.  
In the event of an irregularity as referred to in point (b) of paragraph 1, the operator concerned shall keep the germinal products stored separately until the competent authority has taken a decision regarding them.



Section 2

Movements to other Member States of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry

Article 159

Operators' obligations in respect of movements to other Member States of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry

1.  

Operators shall only move germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to another Member State if those germinal products fulfil the following conditions:

(a) 

they are collected, produced, processed and stored in germinal product establishments approved for that purpose in accordance with Article 97(1) and Article 99;

(b) 

they have been collected from donor animals which fulfil the necessary animal health requirements, in order to ensure that the germinal products do not spread listed diseases;

(c) 

they have been collected, produced, processed, stored and transported in such a way as to ensure that they do not spread listed diseases as referred to in point (d) of Article 9(1).

2.  

Operators shall not move germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry from a germinal product establishment which is subject to movement restrictions 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 adopted pursuant to Article 55(2), Articles 63 and 67, and Articles 71(3), 74(4) and 83(2); and

(c) 

emergency measures as provided for in Articles 257 and 258 and rules adopted pursuant to Article 259, unless derogations have been provided for in rules adopted pursuant to Article 258.

The restrictions provided for in this paragraph shall not apply to cases where the germinal products were collected before the outbreak in question occurred and those products have been stored separately 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, caprine and equine species and germinal products of poultry

1.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning the animal health requirements for movements of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry 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 approved establishments as referred 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 collected, and concerning isolation or quarantine for those animals;

(c) 

laboratory and other tests to be carried out on kept donor animals and germinal products;

(d) 

animal health requirements for the collection, production, processing, storage or other procedures and transport provided for in point (c) of Article 159(1).

2.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the animal health requirements for movements of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to other Member States as provided for in Article 159, specifying derogations for operators from the rules provided for in Article 159, taking into account the risks attached to such germinal products and any risk-mitigation measures in place.



Section 3

Animal health certification and notification of movements

Article 161

Operators' obligations concerning animal health certification for movements of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry and delegated acts

1.  
Operators shall only move germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to another Member State where such products are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with paragraph 3;
2.  

In cases where germinal products of kept animals are allowed to leave a restricted 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 adopted pursuant to Article 55(2), Article 67, Articles 71(3) and 74(4), Article 83(2), or

(b) 

emergency measures as provided for in Articles 257 and 258 and the rules adopted pursuant to Article 259,

and those germinal products are of species subject to those disease control or emergency measures, operators shall only move such germinal products within a Member State or from one Member State to another Member State when they are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 149(1), unless derogations have been granted from the animal health certification requirement in accordance with the rules referred in this subparagraph.

The competent authority may decide that such a certificate does not have to be issued for movements of germinal products within the Member State concerned when that authority considers that an alternative system is in place ensuring that the consignment of such germinal products is traceable and that those germinal products comply with the animal health requirements for such movement.

3.  
Operators shall take all necessary measures to ensure that the animal health certificate referred to in paragraph 1 accompanies the germinal products from their place of origin to their place of destination.
4.  
The competent authority shall, upon request by an operator, issue an animal health certificate for the movements of germinal products referred to in paragraph 1, provided that the relevant requirements referred to in Chapter 5 of Title I of Part IV have been complied with.
5.  
Articles 148, 149 and 150, and the rules adopted pursuant to Articles 146 and 147 and Article 149(4), shall apply to the animal health certification of the germinal products referred to in paragraph 1 of this Article. Article 151(1) and the rules adopted pursuant to Article 151(3) shall apply to the self–declaration of movements of germinal products.
6.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations 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, caprine, porcine and equine species and germinal products of poultry which do not pose a significant risk for the spread of listed diseases due to:

(a) 

the nature of the germinal products concerned or the species of animal that those products come from;

(b) 

the methods of production and processing at the germinal product establishment;

(c) 

the intended use of the germinal products;

(d) 

alternative risk-mitigation measures in place for the type and category 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 reach 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 adopted 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 adopted 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 delegated acts in accordance with Article 264 concerning 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 delegated acts in accordance with Article 264 concerning animal health certification for different types of germinal products and of different animal species.
5.  
The Commission may, by means of implementing acts, lay down rules concerning model forms of animal health certificates for germinal products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 163

Notification of movements of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to other Member States

1.  

Operators shall:

(a) 

inform the competent authority in their Member State of origin in advance of the intended movement of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to another Member State when:

(i) 

the germinal products in question are required to be accompanied by an animal health certificate in accordance with Article 161(1) or (2);

(ii) 

notification of movement is required in accordance with delegated acts adopted pursuant to point (a) of paragraph 5 of this Article for germinal products, taking into account paragraph 3 of this Article;

(b) 

provide all the necessary information to enable the competent authority of the Member State of origin to notify the movement of the germinal products to the competent authority of the Member State of destination in accordance with paragraph 2.

2.  
The competent authority of the Member State of origin shall notify, prior to the movement in question and whenever possible through Traces, the competent authority of the Member State of destination of any movement of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry in accordance with the rules adopted pursuant to paragraphs 5 and 6.
3.  
Member States shall use, for the management of notifications, regions designated in accordance with Article 153(3).
4.  
Article 153(4) shall apply to the notification of germinal products by operators.
5.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

the requirement for advance notification by operators 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 necessary 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 necessary to notify movements of germinal products as provided for in paragraph 1 of this Article;

(c) 

the emergency 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 implementing acts, lay down rules concerning:

(a) 

the provision of information on movements of germinal products by operators to the competent authority of their Member State of origin in accordance with paragraph 1;

(b) 

notification by the competent authority 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 referred to in paragraph 1 by the operator to the competent authority of the Member State of origin;

(ii) 

notification by the competent authority of the Member State of origin of movements of germinal products as referred to in paragraph 2.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



Section 4

Movements to other Member States of germinal products of kept terrestrial animals of species other than bovine, ovine, caprine, porcine and equine species and germinal products of poultry

Article 164

Germinal products of kept terrestrial animals other than those of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry

1.  
Operators shall only move germinal products of kept terrestrial animals of species other than those of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to another Member State if those products do not pose a significant 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.
2.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning animal health requirements, animal health certification and notification requirements for movements of germinal products of kept terrestrial animals of species other than those of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry, taking into account the following matters:

(a) 

listed diseases as referred to in point (d) of Article 9(1) for the listed species concerned;

(b) 

the species of animals from which the germinal products have been collected 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 adopted 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 adopted pursuant to Article 163(5) shall apply for notification of movements.



Section 5

Derogations

Article 165

Germinal products intended for scientific purposes and delegated acts

1.  
The competent authority of the place of destination may, subject to the agreement of the competent authority of the place of origin, authorise movements 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 competent authority shall only grant derogations provided for in paragraph 1 under the following conditions:

(a) 

the competent authorities of the places of destination and origin:

(i) 

have agreed on the conditions for the movements proposed;

(ii) 

ensure that necessary risk-mitigation measures are in place so that those movements do not jeopardise the health status en route and in the place of destination with regard to the listed diseases referred to in point (d) of Article 9(1);

(iii) 

have notified, where relevant, the competent authorities of Member States of passage of the derogation granted and of the conditions under which it is granted;

(b) 

those movements take place under the supervision of the competent authorities of the places of origin and destination, and where relevant, of the competent authorities of any Member States of passage.

3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the rules for the granting of derogations by competent authorities, supplementing those provided for in paragraphs 1 and 2 of this Article.



CHAPTER 6

Production, processing and distribution within the Union of products of animal origin

Article 166

General animal health obligations for operators and delegated acts

1.  

Operators shall take appropriate preventive measures to ensure that, during all stages of the production, processing and distribution of products of animal origin in the Union, such products do not cause the spread of:

(a) 

listed diseases as referred 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.  

Operators shall ensure that products of animal origin do not come from establishments or food businesses, or are not obtained from animals which come from establishments, that are subject to:

(a) 

emergency measures as provided for in Articles 257 and 258 or any rules adopted pursuant to Article 259, unless derogations from the requirement provided for in paragraph 1 of this Article are provided for in rules adopted pursuant to Article 259;

(b) 

movement restrictions applicable to kept terrestrial 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 adopted 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 restrictions have been provided for in those rules.

3.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed requirements supplementing those referred to:

(a) 

in paragraph 1 of this Article on preventive measures, including risk-mitigation measures, and

(b) 

in paragraph 2 of this Article in relation to restrictions on movements of products of animal origin.

4.  

When adopting the delegated acts referred to in paragraph 3, the Commission shall base those acts on:

(a) 

the listed disease in question, as referred to in point (d) of Article 9(1), and species concerned by it and

(b) 

the risks involved.

Article 167

Operators' obligations with regard to animal health certificates and delegated acts

1.  

Operators 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 competent authority of the Member State of origin in accordance with paragraph 3:

(a) 

products of animal origin that:

(i) 

are allowed to be moved from a restricted zone subject to emergency measures as provided for in rules adopted pursuant to Article 259;

(ii) 

originate from animals of species subject to those emergency measures;

(b) 

products of animal origin that:

(i) 

are allowed to be moved from a restricted 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 adopted pursuant to Article 55(2), Articles 63 and 67 and Articles 71(3), 74(4) and 83(2),

(ii) 

originate from animals of species subject to those disease control measures.

The competent authority may decide that such a certificate does not have to be issued for movements of products of animal origin within the Member State concerned when that authority considers that an alternative system is in place ensuring that consignments of such products are traceable and that those products fulfil the animal health requirements for such movements.

2.  
Operators shall take all necessary measures to ensure that the animal health certificate referred to in paragraph 1 accompanies the products of animal origin from their place of origin to their place of destination.
3.  
The competent authority shall, upon request by the operator concerned, issue an animal health certificate for movements of products of animal origin as referred to in paragraph 1, provided that the relevant requirements referred to in this Article have been complied with.
4.  
Articles 148, 149 and 150 and the rules adopted 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 referred to in paragraph 1 of this Article.
5.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations 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 significant risk for the spread of diseases due to:

(a) 

the types of products of animal origin concerned;

(b) 

the risk-mitigation 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 description of the products of animal origin concerned;

(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 adopted 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 restriction requirements provided for in Article 166(2) and in any rules adopted pursuant to Article 166(3).

2.  
The animal health certificate referred to in paragraph 1 may include other information required under other Union legislation.
3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning 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 concerning model forms of animal health certificates for products of animal origin referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 169

Notification of movements of products of animal origin to other Member States

1.  

Operators shall:

(a) 

inform the competent authority in their Member State of origin in advance of intended movements of products of animal origin when the consignments in question are required to be accompanied by an animal health certificate in accordance with Article 167(1);

(b) 

provide all necessary information to enable the competent authority of the Member State of origin to notify the movement in question to the competent authority of the Member State of destination in accordance with paragraph 2.

2.  
The competent authority of the Member State of origin shall, prior to the movement and whenever possible through Traces, notify the competent authority of the Member State of destination of movements of products of animal origin in accordance with the rules adopted pursuant to paragraphs 5 and 6.
3.  
Member States shall use, for the management of notifications, regions designated in accordance with Article 153(3).
4.  
Article 153(4) shall apply to the notification of movements of products of animal origin by operators.
5.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

the information needed for the notification of movements of products of animal origin as provided for in paragraph 1 of this Article;

(b) 

the emergency procedures for the notification 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 implementing acts, lay down rules concerning:

(a) 

the information to be provided by operators to the competent authority of their Member State of origin concerning movements of products of animal origin in accordance with paragraph 1;

(b) 

notification of movements of products of animal origin to be given by the competent authority 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 referred to in paragraph 1 by the operator concerned to the competent authority of the Member State of origin;

(ii) 

notification of movements of products of animal origin to be given by the competent authority of the Member State of origin as referred to in paragraph 2.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 7

Scope of national measures

Article 170

National measures concerning disease control and movements of animals and germinal products

1.  
Member States shall remain free to take national measures to control listed diseases as referred to in points (d) and (e) of Article 9(1) with regard 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 Chapters 3 (Articles 124 to 154), 4 (Articles 155 and 156) and 5 (Articles 157 to 165), and shall not be inconsistent with those rules;

(b) 

not hinder the movement of animals and products between Member States;

(c) 

not exceed the limits of what is appropriate and necessary in order to prevent the introduction and spread of the listed 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 significant risk for the health of kept terrestrial animals in a Member State, the Member State concerned may take national measures to control that disease and may restrict movements of kept terrestrial animals and germinal products, provided those measures do not:

(a) 

hinder the movement of animals and products between Member States;

(b) 

exceed the limits of what is appropriate and necessary in order to control that disease.



TITLE II

AQUATIC ANIMALS AND PRODUCTS OF ANIMAL ORIGIN FROM AQUATIC ANIMALS



CHAPTER 1

Registration, approval, record-keeping and registers



Section 1

Registration of aquaculture establishments

Article 172

Obligation of operators to register aquaculture establishments

1.  

Operators of aquaculture establishments shall, in order for their establishments to be registered in accordance with Article 173, before they commence such activities:

(a) 

inform the competent authority of any aquaculture establishment under their responsibility;

(b) 

provide the competent authority with the following information:

(i) 

the name and address of the operator concerned;

(ii) 

the location of the establishment and a description of its facilities;

(iii) 

the species, categories and quantities (numbers, volume or weight) of aquaculture animals which 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 which are relevant for the purpose of determining the risk posed by it.

2.  

Operators of aquaculture establishments referred to in paragraph 1 shall inform the competent authority in advance of:

(a) 

any significant changes in the aquaculture establishment in question concerning the matters referred to in point (b) of paragraph 1;

(b) 

any cessation of activity by the operator or aquaculture establishment concerned.

3.  
Aquaculture establishments which are subject to approval in accordance with Article 176(1) and Article 177 shall not be required to provide the information referred to in paragraph 1 of this Article.
4.  

An operator 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 operators in that area operate under a common biosecurity system;

(b) 

they are under the responsibility of the same operator and operate under a common biosecurity system, and the aquaculture animals of the establishments concerned form part of a single 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 adopted pursuant to Article 175 which are applicable to a single aquaculture establishment, shall be applicable to the group of aquaculture establishments as a whole.

Article 173

Obligations of the competent authority concerning the registration of aquaculture establishments

A competent authority shall register:

(a) 

aquaculture establishments in the register of aquaculture establishments provided for in Article 185(1), where the operator concerned 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 complied with.

The competent authority shall assign each establishment or group of establishments as referred to in this Article with a unique registration number.

Article 174

Derogations from the obligation of operators to register aquaculture establishments

By way of derogation from Article 172(1), Member States may exempt from the registration requirement certain aquaculture establishments posing an insignificant risk, as provided for in an implementing act adopted in accordance with Article 175.

Article 175

Implementing powers concerning derogations from the obligation to register aquaculture establishments

1.  
The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators for the purpose of the registration of aquaculture establishments as provided for in Article 172(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 concerning the types of aquaculture establishments that may be exempted by Member States from the registration requirement in accordance with Article 174, based on:

(a) 

the species, categories 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 adopted in accordance with the examination procedure referred to in Article 266(2).



Section 2

Approval of certain types of aquaculture establishments

Article 176

Approval of certain aquaculture establishments and delegated acts

1.  

Operators of the following types of aquaculture establishments shall apply to the competent authority for approval in accordance with Article 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 significant risk due to:

(i) 

the species, categories and number of aquaculture animals kept there;

(ii) 

the type of aquaculture establishment concerned;

(iii) 

movements of aquaculture animals into and out of the aquaculture establishment concerned.

2.  

By way of derogation from paragraph 1, Member States may exempt from the obligation to apply for approval operators of the following types of establishment:

(a) 

aquaculture establishments producing a small quantity of aquaculture animals for supply for human consumption 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 restocking with aquaculture animals which 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.

3.  

Unless a derogation has been granted under paragraph 4 of this Article, operators shall not commence activity at an aquaculture establishment as referred to in paragraph 1 of this Article until that establishment has been approved in accordance with Article 181(1), and shall cease such activity at an aquaculture establishment referred to in paragraph 1 of this Article where:

(a) 

the competent authority withdraws or suspends its approval in accordance with Article 184(2); or

(b) 

in the event of conditional approval, granted in accordance with Article 183(3), the aquaculture establishment concerned fails to comply with the outstanding requirements referred to in Article 183(4) and does not obtain a final approval in accordance with Article 183(3).

4.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

derogations from the requirement for operators to apply to the competent authority for approval of the types of aquaculture establishments referred to in point (a) of paragraph 1, concerning types of establishments other than those specified in points (a)(i) and (ii) of paragraph 2, where those establishments do not pose a significant risk;

(b) 

the types of aquaculture establishments which must be approved in accordance with point (b) of paragraph 1.

5.  

When adopting delegated acts as provided for in paragraph 4, the Commission shall base those acts on the following criteria:

(a) 

the species and categories of aquaculture animals kept in an aquaculture establishment;

(b) 

the type of aquaculture establishment and the type of production; and

(c) 

typical movement patterns of the type of aquaculture establishment concerned and of the species or category of aquaculture animals concerned.

6.  
An operator may apply for approval 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 complied with.

Article 177

Approval by the competent authority of groups of aquaculture establishments

The competent authority may grant approval as provided for in Article 181(1) covering a group of aquaculture establishments, provided that the aquaculture establishments in question comply with either of the following conditions:

(a) 

they are located in an epidemiologically linked area and all operators in that area operate under a common biosecurity system; however, any on–shore or off–shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs intended for human consumption (so-called ‘dispatch centres’), establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption (so-called ‘purification centres’) and similar establishments located inside such an epidemiologically linked area must be approved individually;

(b) 

they are under the responsibility of the same operator; and

(i) 

operate under a common biosecurity system; and

(ii) 

the aquaculture animals of the establishments concerned form part of the same epidemiological unit.

When a single approval is granted for a group of aquaculture establishments, the rules laid down in Article 178 and Articles 180 to 184 and the rules adopted pursuant to Articles 180(2) and 181(2), which are applicable to a single aquaculture establishment, shall be applicable to the whole group of aquaculture establishments.

Article 178

Approval of status of confined aquaculture establishments

Operators of aquaculture establishments wishing to obtain the status of a confined establishment shall:

(a) 

apply to the competent authority for approval 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 delegated acts adopted in accordance with Article 203(2) only after their establishment has obtained an approval of that status from the competent authority in accordance with Article 181 or 183.

Article 179

Approval of disease control aquatic food establishments

Operators of disease control aquatic food establishments shall:

(a) 

ensure that the necessary approval in accordance with Article 4 of Regulation (EC) No 853/2004 of the European Parliament and of the Council ( 2 ) has been obtained; and

(b) 

apply to the competent authority, in accordance with Article 180(1), for approval 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 adopted pursuant to Article 63 and Articles 70(3) and 71(3).

Article 180

Obligation of operators to provide information with a view to obtaining approval

1.  

Operators shall, for the purposes of their application for approval of their establishment as provided for in Article 176(1), Article 177, point (a) of Article 178 and Article 179, provide the competent authority with the following information:

(a) 

the name and address of the operator concerned;

(b) 

the location of the establishment concerned and a description of its facilities;

(c) 

the species, categories and quantities (numbers, volume or weight) of aquaculture animals relevant for the approval which are kept on the establishment;

(d) 

the type of aquaculture establishment;

(e) 

in cases of approval of a group of aquaculture establishments, details showing that the group in question complies with the conditions laid down in Article 177;

(f) 

other aspects of the mode of operation of the aquaculture establishment in question which are relevant for determining the risk, posed by it;

(g) 

the water supply to, and discharge of water from, the establishment;

(h) 

the establishment's biosecurity measures.

2.  

Operators of establishments as referred to in paragraph 1 shall inform the competent authority in advance of:

(a) 

any changes in the establishments concerning the matters referred to in paragraph 1;

(b) 

any cessation of activity by the operator or establishment concerned.

3.  
The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators in their application for approval 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 adopted in accordance with the examination procedure referred to in Article 266(2).

Article 181

Granting of, and conditions for, approval and delegated acts

1.  

The competent authority shall only grant approvals 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 referred to in Article 179, where such establishments:

(a) 

comply with the following requirements, where appropriate, in relation to:

(i) 

quarantine, isolation and other biosecurity measures taking into account the requirements provided for in point (b) of Article 10(1)) and any rules adopted pursuant to Article 10(6);

(ii) 

surveillance requirements as provided for in Article 24, where relevant for the type of establishment concerned and the risk involved, in Article 25;

(iii) 

record-keeping as provided for in Articles 186 to 188 and any rules adopted 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 acceptable level, taking into account the type of establishment concerned;

(ii) 

of a capacity adequate for the species, categories and quantity (numbers, volume or weight) of aquatic animals concerned;

(c) 

do not pose an unacceptable risk as regards the spread of diseases, taking into account the risk-mitigation measures in place;

(d) 

have in place a system which enables the operator concerned to demonstrate to the competent authority that the requirements laid down in points (a), (b) and (c) are fulfilled.

2.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

quarantine, isolation and other biosecurity measures as referred to in point (a)(i) of paragraph 1;

(b) 

surveillance as referred 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 delegated acts to be adopted pursuant to paragraph 2, the Commission shall base those rules on the following matters:

(a) 

the risks posed by each type of establishment;

(b) 

the species and categories of aquaculture or aquatic animals relevant for the approval;

(c) 

the type of production concerned;

(d) 

typical movement patterns of the type of aquaculture establishment and species and categories of animals kept in those establishments.

Article 182

Scope of the approval of establishments

The competent authority shall expressly specify in the approval 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 which 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 referred to in Article 179, and in any rules adopted pursuant to point (b) of Article 176(4), the approval applies;

(b) 

for which species and categories of aquaculture animals the approval applies.

Article 183

Procedures for the granting of approval by the competent authority

1.  
The competent authority shall establish procedures for operators to follow when applying for approval of their establishments in accordance with Article 176(1) and Articles 178 and 179.
2.  
Upon receipt of an application for approval from an operator in accordance with Article 176(1), Article 178 or Article 179, the competent authority shall make an on–site visit.
3.  
Provided that the requirements referred to in Article 181 are fulfilled, the competent authority shall grant the approval.
4.  
Where an establishment does not fulfil all requirements for approval as referred to in Article 181, the competent authority may grant conditional approval of an establishment if it appears, on the basis of the application by the operator concerned and the subsequent on-site visit provided for in paragraph 2 of this Article, that the establishment meets all the main requirements that provide sufficient guarantees that the establishment does not pose a significant risk.
5.  
Where conditional approval has been granted by the competent authority in accordance with paragraph 4 of this Article, it shall grant full approval 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 approval, or from documentation provided by the operator within three months from that date, that the establishment meets all the requirements for approval provided for in Article 181(1) and the rules adopted pursuant to Article 181(2).

Where the on–site 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 competent authority may prolong the conditional approval. However, conditional approval shall not be granted for a period exceeding, in total, six months.

Article 184

Review, suspension and withdrawal of approvals by the competent authority

1.  
The competent authority shall keep approvals of establishments granted in accordance with Article 181(1) under review, at appropriate intervals based on the risk involved.
2.  
Where a competent authority identifies serious deficiencies in an establishment as regards compliance with the requirements laid down in Article 181(1) and the rules adopted pursuant to Article 181(2), and the operator of that establishment is not able to provide adequate guarantees that those deficiencies will be eliminated, the competent authority shall initiate procedures to withdraw the approval of the establishment.

However, the competent authority may merely suspend, rather than withdraw, approval of an establishment where the operator can guarantee that it will eliminate those deficiencies within a reasonable period of time.

3.  
Approval shall only be granted after withdrawal or restored after suspension in accordance with paragraph 2 when the competent authority is satisfied that the establishment fully complies with all the requirements of this Regulation appropriate for that type of establishment.



Section 3

Register of aquaculture establishments and disease control aquatic food establishments

Article 185

Register of aquaculture establishments and disease control aquatic food establishments

1.  

Each competent authority shall establish and keep up to date a register of:

(a) 

all aquaculture establishments registered in accordance with Article 173;

(b) 

all aquaculture establishments approved in accordance with Article 181(1);

(c) 

all disease control aquatic food establishments approved 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 concerned;

(c) 

the type of production at the establishment;

(d) 

the water supply to, and discharge from, the establishment, when relevant;

(e) 

the species of aquaculture animals kept at the establishment;

(f) 

up–to–date information on the health status of the registered aquaculture establishment, or, 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 approved in accordance with Article 181(1), the competent authority 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 appropriate and relevant, a competent authority may combine the registration provided for in paragraph 1 with registration for other purposes.
5.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(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-keeping and traceability

Article 186

Record-keeping obligations of operators of aquaculture establishments

1.  

Operators of aquaculture establishments subject to the requirement of registration in accordance with Article 173, or approval in accordance with Article 181(1), shall keep and maintain records containing at least the following information:

(a) 

the species, categories and quantities (numbers, volume or weight) of aquaculture animals on their establishment;

(b) 

movements of aquaculture animals and products of animal origin obtained from those animals into and out of their establishment, stating as appropriate:

(i) 

their place of origin or destination;

(ii) 

the date of such movements;

(c) 

the animal health certificates, in paper or electronic form, required to accompany movements of aquaculture animals arriving at the aquaculture establishment in accordance with Article 208 and the rules adopted pursuant to points (a) and (c) of Article 211(1) and Article 213(2);

(d) 

mortality in each epidemiological unit and other disease problems at the aquaculture establishment as relevant for the type of production;

(e) 

biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for:

(i) 

the species and categories 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 exempted by the Member State concerned 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.  

Operators of aquaculture establishments shall keep the records provided for in paragraph 1 on their aquaculture establishment concerned and shall:

(a) 

keep them in such a way that the tracing of the place of origin and destination of aquatic animals can be guaranteed;

(b) 

make them available to the competent authority on request;

(c) 

retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.

By way of derogation from the requirement that the records are to be kept on their establishment concerned, 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 administered.

Article 187

Record-keeping obligations of disease control aquatic food establishments

1.  

Operators of disease control aquatic food establishments subject to approval 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) 

discharge of water and relevant biosecurity measures.

2.  

Operators 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 competent authority on request;

(b) 

retain those records for a minimum period to be prescribed by the competent authority, which may not be less than three years.

The records shall be kept and maintained in paper or electronic form.

Article 188

Record-keeping obligations of transporters

1.  

Transporters 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, categories and quantities (numbers, volume or weight) of aquatic animals transported by them;

(b) 

mortality rates of the aquaculture animals and wild aquatic animals in question during transport, in so far as is practicable for the type of transport and the species of aquaculture animals and wild aquatic animals transported;

(c) 

aquaculture establishments and disease control aquatic food establishments visited by the means of transport;

(d) 

any exchange of water that took place during transport, specifying the sources of new water and sites of release of water;

(e) 

the cleaning and disinfection of the means of transport.

The records shall be kept and maintained in paper or electronic form.

2.  
Transporters presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1, provided that traceability is ensured.
3.  

Transporters shall keep the records provided for in paragraph 1:

(a) 

in such a manner that they can be made immediately available to the competent authority on request;

(b) 

for a minimum period to be prescribed by the competent authority, which may not be less than three years.

Article 189

Delegation of powers concerning record-keeping

1.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules supplementing the record-keeping requirements provided for in Articles 186, 187 and 188, as regards information to be recorded by operators in addition to that provided for in Articles 186(1), 187(1) and 188(1).
2.  

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

(a) 

the risks posed by each type of aquaculture establishment or transport;

(b) 

the species and categories of aquatic animals kept on the aquaculture establishment concerned, or transported to or from that establishment;

(c) 

the type of production of the establishment;

(d) 

typical movement patterns for the type of aquaculture establishment or disease control aquatic food establishment;

(e) 

the numbers, volume or weight of aquatic animals kept on the establishment or transported to or from it.

Article 190

Implementing powers concerning exemptions from the record-keeping requirements

The Commission may, by means of implementing acts, lay down rules concerning the types of aquaculture establishments and operators that may be exempted by Member States from the record-keeping requirements provided for in Articles 186 and 188, as regards:

(a) 

operators of certain categories of aquaculture establishments and transporters;

(b) 

aquaculture establishments keeping, or transporters transporting, respectively, a small number of aquaculture animals or a small number of aquatic animals;

(c) 

certain species and categories 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 adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 2

Movements within the Union of aquatic animals



Section 1

General requirements for movements

Article 191

General requirements for movements of aquatic animals

1.  

Operators shall take appropriate measures to ensure that the movement of aquatic animals does not jeopardise the health status at the place of destination with regard to:

(a) 

the listed diseases referred to in point (d) of Article 9(1);

(b) 

emerging diseases.

2.  

Operators shall only move aquatic animals into an aquaculture establishment or for human consumption purposes, or release them into the wild, if the animals in question fulfil the following conditions:

(a) 

they come, except in the case of wild aquatic animals, from establishments that have been:

(i) 

registered by the competent authority in accordance with Article 173,

(ii) 

approved by that competent authority in accordance with Articles 181 and 182, when required by Article 176(1), Article 177 or Article 178, or

(iii) 

granted a derogation from the registration requirement laid down in Article 173.

(b) 

they are not subject to:

(i) 

movement restrictions affecting the species and categories concerned 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 adopted 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 adopted pursuant to Article 259.

However, operators may move those aquatic animals where derogations from the movement restrictions for such movements or release are provided for in Title II of Part III (Articles 53–83) or derogations from emergency measures are provided for in rules adopted pursuant to Article 259.

3.  
Operators shall take all necessary measures to ensure that aquatic animals, after leaving their place of origin, are consigned directly to the final place of destination.

Article 192

Disease prevention measures in relation to transport

1.  

Operators shall take the appropriate and necessary disease prevention measures to ensure that:

(a) 

the health status of aquatic animals is not jeopardised during transport;

(b) 

transport operations of aquatic animals do not cause the potential spread of listed diseases as referred 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 transport and other adequate biosecurity measures are taken, as appropriate to the risks involved with the transport operations concerned;

(d) 

any exchanges of water and discharges of water during the transport 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 listed diseases referred to in point (d) of Article 9(1) of:

(i) 

the aquatic animals being transported;

(ii) 

any aquatic animals en route to the place of destination;

(iii) 

aquatic animals at the place of destination.

2.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

the conditions and requirements for cleaning and disinfection of equipment and means of transport in accordance with point (c) of paragraph 1 of this Article and the use of biocidal products for such purposes;

(b) 

other appropriate biosecurity measures during transport as provided for in point (c) of paragraph 1 of this Article;

(c) 

water exchanges and discharges of water during transport as provided for in point (d) of paragraph 1 of this Article.

Article 193

Change of intended use

1.  

Aquatic animals which are moved for destruction 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 adopted pursuant to Article 55(2), Articles 63 and 67, Articles 70(3), 71(3) and 74(4), and Article 83(2);

(b) 

emergency measures as provided for in Articles 257 and 258 and in rules adopted pursuant to Article 259.

2.  
Aquatic animals moved for human consumption, 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 competent authority of the place of destination may authorise a change of use of aquatic animals for a purpose other than that originally intended, 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 intended use.

Article 194

Obligations of operators at the place of destination

1.  

Operators of aquaculture establishments and disease control aquatic food establishments receiving aquatic animals and operators 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 adopted pursuant to Articles 189, 211 and 213;

(ii) 

the self–declaration documents provided for in Article 218(1) and in the rules adopted pursuant to Article 218(3) and (4);

(b) 

inform the competent authority of the place of destination, after checking the aquatic animals received, of any irregularity 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 irregularity as referred to in point (b) of paragraph 1, the operator shall isolate the aquatic animals concerned by that irregularity until the competent authority of the place of destination has taken a decision regarding them.

Article 195

General requirements in respect of movements of aquaculture animals passing through Member States but intended for export from the Union to third countries or territories

Operators shall ensure that aquaculture animals intended for export to a third country or territory and passing through the territory of another Member State fulfil the requirements laid down in Articles 191, 192 and 193.



Section 2

Aquatic animals intended for aquaculture establishments or release into the wild

Article 196

Abnormal mortalities or other serious disease symptoms

1.  

Operators 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 symptoms; and

(b) 

originate from an aquaculture establishment or environment where there are no abnormal mortalities with an undetermined cause.

2.  
By way of derogation from paragraph 1, the competent authority may, on the basis of an evaluation of the risks involved, authorise 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 abnormal mortalities or other disease symptoms have occurred.

If the movement or release referred to in this paragraph is to be made to another Member State, it shall only be authorised by the competent authority if the competent authorities of the Member State of destination and, where relevant, of the Member States of passage have given their consent to such movement or release.

Article 197

Movements of aquaculture animals intended for Member States, zones or compartments which have been declared disease-free or which are subject to an eradication programme, and delegated acts

1.  
Operators shall only move aquaculture animals of listed 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 compartment which has been declared free of those listed diseases in accordance with Article 36(4) or 37(4), if the animals in question originate from a Member State, or a zone or compartment thereof, which has been declared free of those diseases.
2.  
Operators shall only move aquaculture animals of listed 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 compartment 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 compartment thereof, which has been declared free of those listed diseases.
3.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations from the movement or release requirements laid down in paragraphs 1 and 2 of this Article which do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) on account of:

(a) 

the species, categories, and life stage of the aquaculture animals concerned;

(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-mitigation measures applied at the place of origin or destination.

Article 198

Derogations by Member States concerning the obligation of operators for movement of aquaculture animals between Member States, zones or compartments which are subject to an eradication programme

By way of derogation from Article 197(1) and (2), Member States may authorise operators to move aquaculture animals into a zone or compartment for which an eradication programme has been established in accordance with Article 31(1) and (2) as regards the listed diseases referred to in points (b) and (c) of Article 9(1), from another zone or compartment for which such a programme has also been established for the same listed diseases, provided that such movement will not jeopardise the health status of the Member State, zone or compartment of destination.

If such movements are to be made to another Member State, the competent authority shall only authorise them if the competent authorities 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 concerning 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 compartment thereof, which has been declared disease–free in accordance with Article 36(1) or Article 37(1) as regards one or more of the listed diseases referred to in points (b) and (c) of Article 9(1) for which the species of aquatic animals to be moved is a listed species, regardless of the health status of the area where those aquatic animals are to be released.

Article 200

Movements of wild aquatic animals intended for Member States, or zones or compartments thereof, which have been declared disease–free or which are subject to an eradication programme, 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.  

Operators shall take the appropriate and necessary 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 referred to in point (d) of Article 9(1) to aquatic animals at the place of destination; and

(b) 

risk-mitigation or other adequate biosecurity measures are in place where necessary to ensure compliance with point (a).

3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the disease prevention and risk-mitigation measures to be taken by operators as provided for in paragraph 2 of this Article. Pending the adoption of such delegated acts, the competent authority 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 compartments thereof, which have been declared disease–free or which are subject to an eradication programme, and delegated acts

1.  
Operators shall only move live aquaculture animals of listed species relevant for listed diseases as referred to in points (b) or (c) of Article 9(1) intended for human consumption to a Member State, or to a zone or compartment thereof, which 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 regards one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), if the animals in question originate from a Member State, or a zone or compartment thereof, which has been declared disease–free in accordance with Article 36(4) or Article 37(4).
2.  
By way of derogation from paragraph 1 of this Article, Member States may authorise operators to introduce live aquaculture animals into a zone or compartment 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 compartment for which such a programme has also been established as regards the same diseases within that Member State, provided that such movement will not jeopardise the health status of the Member State or of the zone or compartment thereof.
3.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the derogations provided for in paragraph 2 of this Article in respect of movements of live aquaculture animals which do not pose a significant risk of spreading of diseases on account of:

(a) 

the species, categories, and live stage of the aquaculture animals concerned;

(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;

(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 compartments thereof, which have been declared disease–free or which are subject to an eradication programme, and delegated acts

1.  
Article 201(1) and (2) and the rules adopted pursuant to Article 201(3) shall apply to movements of live wild aquatic animals intended for human consumption and which are intended for Member States, or zones or compartments thereof, which have been declared disease–free in accordance with Articles 36(4) or 37(4) or which are subject to an eradication programme in accordance with Article 31(1) or (2), where the measures adopted pursuant thereto are necessary in order to ensure that the animals in question do not pose a significant 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.  
Paragraph 1 of this Article shall also apply to live aquatic animals not covered by the definition of aquaculture animals contained in Article 4(7).
3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning movement requirements for wild aquatic animals intended for human consumption, supplementing paragraphs 1 and 2 of this Article.



Section 4

Derogations from Sections 1 to 3 (Articles 191 to 202) and additional risk-mitigation measures

Article 203

Aquatic animals intended for confined establishments for aquaculture and delegated acts

1.  

Operators shall only move aquatic animals to a confined 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 listed diseases as referred to in point (d) of Article 9(1) to listed species of animals at the confined establishment for aquaculture of destination, except where the movement in question is authorised for scientific purposes.

2.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

detailed rules for movements of aquaculture animals to confined establishments for aquaculture in addition to those provided for in paragraph 1 of this Article;

(b) 

specific rules for movements of aquaculture animals to confined establishments for aquaculture where the risk-mitigation measures in place guarantee that such movements do not pose a significant risk for the health of aquaculture animals within that confined establishment for aquaculture and the surrounding establishments.

Article 204

Movements of aquatic animals for scientific purposes and delegated acts

1.  
The competent authority of the place of destination may, subject to the agreement of the competent authority of the place of origin, authorise movements 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 exception of Article 191(1) and (3) and Articles 192, 193 and 194.
2.  

The competent authority referred to in paragraph 1 shall only grant derogations as provided for in that paragraph under the following conditions:

(a) 

the competent authorities of the places of destination and origin:

(i) 

have agreed on the conditions for such movements;

(ii) 

ensure that the necessary risk-mitigation 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 referred to in point (d) of Article 9(1);

(iii) 

have notified, where relevant, the competent authorities of the Member States of passage of the derogation granted and of the conditions under which it is granted;

(b) 

those movements take place under the supervision of the competent authorities of the places of origin and destination, and where relevant, the competent authorities of the Member States of passage.

3.  
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules for the granting of derogations by competent authorities, supplementing those provided for in paragraphs 1 and 2 of this Article.

Article 205

Other specific uses of aquatic animals, specific requirements and derogations and delegation of powers

1.  
Operators shall take the necessary preventive measures to ensure that movements of aquatic animals intended 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 empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

specific 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) 

sports fishing, including fishing baits;

(iv) 

cultural and similar events;

(v) 

commercial aquaria; or

(vi) 

health care and other similar uses.

(b) 

derogations from Sections 1 to 3 (Articles 191 to 202) with the exception 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 biosecurity provisions are in place to ensure that those movements do not pose a significant risk to the health status of the place of destination.

Article 206

Implementing power to adopt temporary rules for movements of specific species or categories of aquatic animals

1.  

The Commission may, by means of implementing acts, lay down temporary rules, by way of addition or alternative to those laid down in this Chapter, for movements of specific species or categories 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 adopted pursuant to Articles 197(3), 200(3), 202(3), 203(2) and 204(3) and Article 205 do not efficiently mitigate the risks posed by the movement of those aquatic animals; or

(b) 

a listed disease as referred 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 adopted in accordance with the examination procedure referred to in Article 266(2).

2.  
On duly justified imperative grounds of urgency relating to a listed disease representing a risk of a highly significant impact and taking into account the matters referred to in Article 205, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 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 delegated 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 referred to in those provisions;

(b) 

the health status as regards the listed diseases referred to in point (d) of Article 9(1) at the places of origin, passage and destination;

(c) 

listed aquatic animal species for the listed diseases referred to in point (d) of Article 9(1);

(d) 

biosecurity measures in place at the places of origin, passage and destination;

(e) 

any specific conditions under which the aquaculture animals are kept;

(f) 

specific movement patterns of the type of aquaculture establishment and the species or category of aquatic animals concerned;

(g) 

other epidemiological factors.



Section 5

Animal health certification

Article 208

Obligation of operators to ensure that aquaculture animals are accompanied by an animal health certificate

1.  
Operators shall only move aquaculture animals if they are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 216(1), where the animals in question are of listed species for the listed diseases referred to in points (b) and (c) of Article 9(1) and are intended for introduction into a Member State, or a zone or compartment thereof, which 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 referred to in points (b) and (c) of Article 9(1).
2.  
Operators shall only move aquaculture animals if they are accompanied by an animal health certificate issued by the competent authority 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) referred to in points (a) and (b) of Article 9(1) and are allowed to leave a restricted 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 adopted 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 referred to in points (a) and (b) of Article 9(1).
3.  
Operators shall take all necessary measures to ensure that the animal health certificate accompanies the aquaculture animals from their place of origin to their final place of destination, unless specific measures are provided for in rules adopted pursuant to Article 214.

Article 209

▼C1

Obligation of operators to ensure that other aquatic animals are accompanied by an animal health certificate

▼B

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), operators shall only move those aquatic animals if the animals in question are accompanied by an animal health certificate issued by the competent authority 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 intended for an aquaculture establishment or release into the wild. Where the competent authority 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 authorise their movement without an animal health certificate subject to the consent of the competent authority of the place of destination.
3.  
This Article shall not apply to wild aquatic animals harvested or caught for direct human consumption.

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 territories provided that they have in place an alternative system to ensure that consignments of such animals are traceable and those consignments comply 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 concerning animal health certification in respect of aquatic animals

1.  

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

the requirement for animal heath certification for movements of aquatic animals other than aquaculture animals as referred to in Article 209(1), in cases where animal health certification is imperative in order to ensure that the movement in question complies with the following animal health requirements for the listed species of animals concerned:

(i) 

the requirements provided for in Sections 1 to 4 (Articles 191 to 207) and the rules adopted 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 adopted pursuant to Article 55(2), Articles 63, 67 and 68, and Articles 71(3), 74(4) and 83(2);

(iii) 

emergency measures as provided for in the rules adopted pursuant to Article 259;

(b) 

special rules for animal health certification as provided for in Articles 208 and 209 where specific risk-mitigation measures are taken by the competent authority to ensure:

(i) 

the traceability of the aquatic animals being moved;

(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 which do not pose a significant risk of the spread of diseases, on account of:

(i) 

species, the categories or live stage of the aquatic animals concerned;

(ii) 

the methods of keeping and the type of production of those species and categories of aquaculture animals;

(iii) 

the intended use of the aquatic animals; or

(iv) 

the place of destination of the aquatic animals.

2.  
The Commission shall, by means of implementing acts, lay down rules concerning the obligation of operators, as provided for in Article 209(2), to ensure that wild aquatic animals intended for an aquaculture establishment are accompanied by an animal health certificate.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 212

Contents of animal health certificates

1.  

The animal health certificate referred 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 route;

(b) 

a description, including the species and category, of the aquatic animals concerned;

(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 concerning the content of animal health certificates

1.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning the content of animal health certificates as provided for in Article 212(1):

(a) 

detailed rules on the content of those animal health certificates provided for in Article 212(1) for different species and categories of aquatic animals;

(b) 

additional information to be contained in the animal health certificate provided for in Article 212(1).

2.  
The Commission may, by means of implementing acts, lay down rules concerning the model forms for the animal health certificates.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 214

Delegation of powers concerning specific types of movements of aquatic animals to the place of destination

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning specific 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 return to their place of origin or to be moved to a different destination, for one or more of the following reasons:

(i) 

their intended journey was unexpectedly interrupted for animal welfare reasons;

(ii) 

unforeseen accidents or events during the journey;

(iii) 

they were rejected at the place of the destination in another Member State or at the external border of the Union;

(iv) 

they were rejected in a third country or territory;

(b) 

movements of aquaculture animals intended for exhibitions and for sporting, cultural and similar events, and their subsequent return to their place of origin.

Article 215

Operators' obligations to cooperate with the competent authorities for the purposes of animal health certification

Operators shall:

(a) 

provide the competent authority with all the information necessary to complete the animal health certificate provided for in Articles 208 and 209 and in the rules adopted pursuant to Articles 211, 213 and 214, in advance of the intended movement;

(b) 

where necessary, ensure that the aquatic animals in question are subjected to documentary, identity and physical checks as provided for in Article 216(3) and in the rules adopted pursuant to Article 216(4).

Article 216

Responsibility of the competent authority for animal health certification and delegated acts

1.  

The competent authority shall, upon request by an operator, issue an animal health certificate for the movement of aquatic animals, where required by Articles 208 and 209, or by rules adopted pursuant to Articles 211 and Article 214, provided that the following animal health requirements have been complied 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 delegated acts adopted 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 adopted pursuant to Article 206.

2.  

Animal health certificates shall:

(a) 

be verified, stamped and signed by an official veterinarian;

(b) 

remain valid for the period of time, provided for in the rules adopted 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 veterinarian concerned shall verify, by means of documentary, identity and physical checks as provided for by delegated acts adopted pursuant to paragraph 4 where appropriate, that the aquatic animals covered by it fulfil the requirements of this Chapter, taking into account the species and categories of aquatic animals concerned and the animal health requirements.
4.  

The Commission shall adopt delegated acts in accordance with Article 264 laying down rules concerning:

(a) 

the types of documentary, identity and physical checks and examinations in relation to different species and categories of aquatic animals that must be carried out by the official veterinarian in accordance with paragraph 3 in order to verify compliance with the requirements of this Chapter;

(b) 

the timeframes for the carrying-out of such documentary, identity and physical checks and examinations, and the issuing of animal health certificates by the official veterinarian 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 accompanying 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 adopted 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 competent authorities of the Member States of origin, passage and destination are able to have access to the electronic documents at all times during the transport.

Article 218

Self–declaration by operators for movements of aquaculture animals to other Member States and delegated acts

1.  
Operators at the place of origin shall issue a self–declaration document for movements of aquaculture animals from their place of origin in one Member State to their place of destination in another Member State, and shall ensure that it accompanies 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 adopted pursuant to Articles 211 and Article 214.
2.  

The self–declaration document provided for in paragraph 1 shall contain at least the following information concerning the aquaculture animals in question:

(a) 

their places of origin and destination, and, when relevant, any places en route;

(b) 

the means of transport

(c) 

a description of the aquaculture animals, and their categories, species and quantity (numbers, volume or weight), as relevant for the animals concerned;

(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 empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) 

detailed rules on the content of the self–declaration document provided for in paragraph 2 of this Article for different species and categories of aquaculture animals;

(b) 

additional information to be contained in the self–declaration document to the one provided for in paragraph 2 of this Article.

4.  
The Commission may, by means of implementing acts, lay down rules for a model form of the self–declaration document provided for in paragraph 1.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



Section 6

Notification of movements of aquatic animals to other Member States

Article 219

Obligation of operators concerning the notification of movements of aquatic animals to other Member States

1.  

Operators other than transporters shall notify the competent authority in their Member State of origin in advance of intended 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 competent authority of the Member State of origin in accordance with Articles 208 and 209 ►C1  and any rules adopted pursuant to Articles 211 and 214; ◄

(b) 

the aquatic animals are required to be accompanied by an animal health certificate for aquatic animals ►C1  when they are being moved from a restricted zone as referred to in Article 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 approval in accordance with Articles 176 to 179;

(ii) 

release into the wild;

(d) 

notification is required in accordance with delegated acts adopted pursuant to Article 221.

2.  
For the purposes of the notification provided for in paragraph 1 of this Article, operators shall provide the competent authority of their Member State of origin with all the necessary information to enable it to notify the movement to the competent authority of the Member State of destination in accordance with Article 220(1).

Article 220

Responsibility of the competent authority to notify movements of aquatic animals to other Member States

1.  
The competent authority of the Member State of origin shall notify the competent authority of the Member State of destination of movements of aquatic animals as referred to in Article 219, unless a derogation has been granted in accordance with point (c) of Article 221(1) as regards such notification.
2.  
The notification referred to in paragraph 1 shall be carried out prior to the movement in question and, whenever possible, through Traces.
3.  
Member States shall designate regions for the management of notifications of movements as provided for in paragraph 1.
4.  
By way of derogation from paragraph 1, the competent authority of Member State of origin may authorise the operator concerned to notify, partially or completely, movements of aquatic animals through Traces to the competent authority of the Member State of destination.

Article 221

Delegation of powers and implementing acts for the notification of movements of aquatic animals by operators and by the competent authority

1.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) 

the requirement for advance notification by operators, in accordance with Article 219, of movements between Member States of aquatic animals of species or categories other than those referred to in points (a), (b) and (c) of Article 219(1), where traceability of such movements is necessary in order to ensure compliance with the animal health requirements laid down in this Chapter;

(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 notification requirements provided for in point (c) of Article 219(1) for species and categories of aquatic animals or types of movements which pose an insignificant risk;

(d) 

the emergency procedures for notification of movements of aquatic animals in the 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 implementing acts, lay down rules concerning:

(a) 

the details of notifications by:

(i) 

operators to the competent authority of the Member State of origin of movements of aquatic animals in accordance with Article 219;

(ii) 

the competent authority of the Member State of origin to the Member State of destination of movements of aquatic animals in accordance with Article 220(1);

(b) 

the deadlines for:

(i) 

the provision by operators of the necessary information referred to in Article 219(2) to the competent authority of the Member State of origin;

(ii) 

the notification of movements by the competent authority of the Member State of origin as referred to in Article 220(1).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).



CHAPTER 3

Production, processing and distribution within the Union of products of animal origin from aquatic animals, other than live aquatic animals

Article 222

General animal health obligations for operators and delegated acts

1.  

Operators shall take appropriate preventive measures to ensure that, during all stages of the production, processing and distribution of products of animal origin from aquatic animals, other than live aquatic animals, those products do not cause the spread of:

(a) 

listed diseases as referred to in point (d) of Article 9(1), taking into account the health status of the place of production, processing and destination;

(b) 

emerging diseases.

2.  

Operators shall ensure that products of animal origin from aquatic animals, other than live aquatic animals, do not come from establishments or food businesses, or are not obtained from animals which come from such establishments or food businesses, that are subject to:

(a) 

emergency measures as provided for in Articles 257 and 258 and any rules adopted pursuant to Article 259, unless derogations have been provided for in respect of those rules in Part VII (Articles 257 to 262);

(b) 

movement restrictions 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 adopted 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 restrictions have been provided for in those rules.

3.  

The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed requirements supplementing those referred 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 concerned by the diseases, for which emergency measures or movement restrictions as referred to in paragraph 2 of this Article apply;

(b) 

the types of products of animal origin from aquatic animals;

(c) 

the risk-mitigation 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 consumption.

Article 223

Animal health certificates and delegated acts

1.  

Operators shall only move the following products of animal origin from aquatic animals other than live aquatic animals where those products are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with paragraph 3:

(a) 

products of animal origin from aquatic animals that:

(i) 

are allowed to leave a restricted zone subject to emergency measures as provided for in rules adopted pursuant to Article 259; and

(ii) 

originate 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 restricted zone subject to disease control measures in accordance with point (c) of Article 32(1), point (c) of Article 55(1), Article 56, ►C1  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) and Article 79 and the rules adopted pursuant to Article 55(2), Articles 63 and 67 and Articles 71(3), 74(4) and 83(2); and

(ii) 

originate from aquatic animals of species subject to those disease control measures.

2.  

By way o