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
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;
  • (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;
  • (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 ([^E0002]) has been obtained; and

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