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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)

Type Regulation

Publication 2016-03-31

Last updated 2021-04-21

State In force

Department Council of the European Union, European Parliament

Source EUR-Lex

articles 282

Reform history JSON API

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

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.

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

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

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.

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.

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

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.

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.

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

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.

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

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.

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.

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

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;

(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.

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).

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.

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;

(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

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.

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.

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

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).

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;

(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.

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;

(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

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).

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.

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.

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.

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

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.

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.

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

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.

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.

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

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.

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.

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.

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

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;

(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.

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

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;

(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.

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.

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

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.

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.

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

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.

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;

(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

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.

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.

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;

(d) a computer database of kept terrestrial animals as provided for in Article 109(1).

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;

(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.

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

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.

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

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.

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

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).

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

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;

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

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).

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.

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

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.

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;

(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

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).

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).

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

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

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

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;

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.

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;

(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

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.

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

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.

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

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).

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

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).

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

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.

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;

(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

Operators of slaughterhouses receiving kept ungulates and poultry from another Member State shall slaughter those animals as soon as possible following their arrival and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to paragraph 2.

The Commission shall 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

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.

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

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.

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.

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;

(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

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.

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

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