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.
Article 136 Movements of kept terrestrial animals other than kept ungulates and poultry to other Member States and delegated acts
1. Operators shall only move kept terrestrial animals other than kept ungulates or poultry from an establishment in one Member State to another Member State if the animals in question do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) at the place of destination. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules to ensure that kept terrestrial animals other than kept ungulates or poultry do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1), as provided for in paragraph 1 of this Article. 3. When establishing the detailed rules to be laid down in the delegated acts provided for in paragraph 2, the Commission shall base those rules on the following considerations: (a) the listed diseases referred to in point (d) of Article 9(1) relevant for the listed species or the category of kept terrestrial animals to be moved; (b) the health status as regards the listed diseases referred to in point (d) of Article 9(1) in the establishments, compartments, zones and Member States of origin and the place of destination; (c) the types of establishment and the types of production at the place of origin and the place of destination; (d) the types of movement in respect of the final use of animals at the place of destination; (e) the species and categories of kept terrestrial animals to be moved; (f) the age of the kept terrestrial animals to be moved; (g) other epidemiological factors.
Article 137 Kept terrestrial animals intended for confined establishments and delegated acts
1. Operators shall only move kept terrestrial animals to a confined establishment if the animals in question fulfil the following conditions: (a) they originate from another confined establishment; (b) they do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to listed species or to categories of animals at the confined establishment of destination, except where the movement in question is authorised for scientific purposes. 2. The Commission shall adopt delegated acts in accordance with Article 264 concerning: (a) detailed rules for movements of kept terrestrial animals into confined establishments in addition to those provided for in paragraph 1 of this Article; (b) specific rules for movements of kept terrestrial animals into confined establishments where the risk-mitigation measures in place guarantee that such movements do not pose a significant risk for the health of kept terrestrial animals within that confined establishment and the surrounding establishments.
Article 138 Movements of kept terrestrial animals for scientific purposes and delegated acts
1. The competent authority of the place of destination may, subject to the agreement of the competent authority of the place of origin, authorise movements of kept terrestrial animals into the territory of the Member State of destination, for scientific purposes, where those movements do not comply with the requirements of Sections 1 to 5 (Articles 124 to 136), with the exception of Articles 124 and 125, point (b)(ii) of Article 126(1) and Article 127. 2. The competent authority of the place of destination shall only grant derogations as provided for in paragraph 1 under the following conditions: (a) the competent authorities of the places of destination and origin: (i) have agreed on the conditions for such movements; (ii) ensure that the necessary risk-mitigation measures are in place so that those movements do not jeopardise the health status in places en route and in the place of destination with regard to the listed diseases referred to in point (d) of Article 9(1); and (iii) have notified, where relevant, the competent authorities of the Member States of passage of the derogation granted and of the conditions under which it is granted; and (b) those movements of those animals take place under the supervision of the competent authorities of the places of origin and destination, and where relevant, the competent authorities of the Member States of passage. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules for the granting of derogations by competent authorities, supplementing those provided for in paragraphs 1 and 2 of this Article.
Article 139 Derogations concerning recreational use, sporting and cultural events, work near borders and grazing
1. The competent authority of the place of destination may grant derogations from the requirements of Sections 2 to 5 (Articles 126 to 136), with the exception of points (a),(b) and (c) of Article 126(1) and Articles 127 and 128, for intra–Union movements of kept terrestrial animals between Member States where such movements are for: (a) recreational use near borders; (b) exhibitions, and sporting, cultural and similar events, organised near borders; (c) grazing of kept terrestrial animals in grazing areas shared between Member States; or (d) work done by kept terrestrial animals near borders of Member States. 2. Derogations by the competent authority of the place of destination for movements of kept terrestrial animals for the purposes provided for in paragraph 1 shall be agreed on between the Member States of origin and destination and appropriate risk-mitigation measures shall be taken to ensure that such movements do not pose a significant risk. 3. The Member States referred to in paragraph 2 shall inform the Commission of the granting of derogations as provided for in paragraph 1. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules for the granting of derogations by the competent authority of the place of destination, supplementing those provided for in paragraph 1 of this Article.
Article 140 Delegation of power concerning circuses, exhibitions, sporting events and recreational use, zoos, pet shops, animal shelters and wholesalers
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) specific requirements supplementing the rules laid down in Sections 2 to 5 (Articles 126 to 136) for movements of kept terrestrial animals for the following purposes: (i) circuses, zoos, pet shops, animal shelters and wholesalers; (ii) exhibitions and sporting, cultural and similar events; (b) derogations from Sections 2 to 5 (Articles 126 to 136), with the exception of points (a), (b) and (c) of Article 126(1) and Articles 127 and 128, for movements of kept terrestrial animals as referred to in point (a) of this Article.
Article 141 Implementing power to adopt temporary rules for movements of specific species or categories of kept terrestrial animals
1. The Commission may, by means of implementing acts, lay down temporary rules, by way of addition or alternative to those laid down in this Chapter, for movements of specific species or categories of kept terrestrial animals where: (a) the movement requirements provided for in Article 130, Article 132(1), Articles 133 and 134, Articles 136(1), 137(1) and 138(1) and (2) and Article 139 and the rules adopted pursuant to Articles 131(1) and 132(2), Article 135, Articles 136(2), 137(2), 138(3) and 139(4) and Article 140 are not effectively mitigating the risks posed by the movement of such animals; or (b) a listed disease as referred to in point (d) of Article 9(1) appears to be spreading despite the movement requirements laid down in accordance with Sections 1 to 6 (Articles 124 to 142). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2). 2. On duly justified imperative grounds of urgency relating to diseases representing a risk of a highly significant impact and taking into account the matters referred to in Article 142, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).
Article 142 Matters to be taken into account in the adoption of delegated and implementing acts as provided for in this Section
When establishing the rules to be laid down in the delegated and implementing acts provided for in Articles 137(2), 138(3) and 139(4) and Articles 140 and 141, the Commission shall base those rules on the following matters: (a) the risks involved with the movements referred to in those provisions; (b) the health status as regards the listed diseases referred to in point (d) of Article 9(1) at the places of origin, passage and destination; (c) listed animal species for the listed diseases referred to in point (d) of Article 9(1); (d) biosecurity measures in place at the places of origin, passage and destination (e) any specific conditions in establishments under which the kept terrestrial animals are kept; (f) specific movement patterns of the type of establishment and the species and category of kept terrestrial animals concerned; (g) other epidemiological factors.
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(4) 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).
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).
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).
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.
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.
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).
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.
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.
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).
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.
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).
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 ( 62 ) has been obtained; and (b) apply to the competent authority, in accordance with Article 180(1), for approval to slaughter or process aquatic animals for disease control purposes in accordance with point (b) of Article 61(1), Article 62 and Articles 68(1), 79 and 80 and the rules adopted pursuant to Article 63 and Articles 70(3) and 71(3).
Article 180 Obligation of operators to provide information with a view to obtaining approval
1. Operators shall, for the purposes of their application for approval of their establishment as provided for in Article 176(1), Article 177, point (a) of Article 178 and Article 179, provide the competent authority with the following information: (a) the name and address of the operator concerned; (b) the location of the establishment concerned and a description of its facilities; (c) the species, categories and quantities (numbers, volume or weight) of aquaculture animals relevant for the approval which are kept on the establishment; (d) the type of aquaculture establishment; (e) in cases of approval of a group of aquaculture establishments, details showing that the group in question complies with the conditions laid down in Article 177; (f) other aspects of the mode of operation of the aquaculture establishment in question which are relevant for determining the risk, posed by it; (g) the water supply to, and discharge of water from, the establishment; (h) the establishment's biosecurity measures. 2. Operators of establishments as referred to in paragraph 1 shall inform the competent authority in advance of: (a) any changes in the establishments concerning the matters referred to in paragraph 1; (b) any cessation of activity by the operator or establishment concerned. 3. The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators in their application for approval of their establishment, in accordance with paragraph 1, including the time-limits by which such information is to be provided. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 181 Granting of, and conditions for, approval and delegated acts
1. The competent authority shall only grant approvals of aquaculture establishments as referred to in Article 176(1) and point (a) of Article 178, groups of aquaculture establishments as referred to in Article 177 and disease control aquatic food establishments as referred to in Article 179, where such establishments: (a) comply with the following requirements, where appropriate, in relation to: (i) quarantine, isolation and other biosecurity measures taking into account the requirements provided for in point (b) of Article 10(1)) and any rules adopted pursuant to Article 10(6); (ii) surveillance requirements as provided for in Article 24, where relevant for the type of establishment concerned and the risk involved, in Article 25; (iii) record-keeping as provided for in Articles 186 to 188 and any rules adopted pursuant to Articles 189 and 190; (b) have facilities and equipment that are: (i) adequate to reduce the risk of the introduction and spread of diseases to an acceptable level, taking into account the type of establishment concerned; (ii) of a capacity adequate for the species, categories and quantity (numbers, volume or weight) of aquatic animals concerned; (c) do not pose an unacceptable risk as regards the spread of diseases, taking into account the risk-mitigation measures in place; (d) have in place a system which enables the operator concerned to demonstrate to the competent authority that the requirements laid down in points (a), (b) and (c) are fulfilled. 2. The Commission shall adopt delegated acts in accordance with Article 264 concerning: (a) quarantine, isolation and other biosecurity measures as referred to in point (a)(i) of paragraph 1; (b) surveillance as referred to in point (a)(ii) of paragraph 1; (c) facilities and equipment as referred to in point (b) of paragraph 1. 3. When establishing the rules to be laid down in the delegated acts to be adopted pursuant to paragraph 2, the Commission shall base those rules on the following matters: (a) the risks posed by each type of establishment; (b) the species and categories of aquaculture or aquatic animals relevant for the approval; (c) the type of production concerned; (d) typical movement patterns of the type of aquaculture establishment and species and categories of animals kept in those establishments.
Article 182 Scope of the approval of establishments
The competent authority shall expressly specify in the approval of an aquaculture establishment or a disease control aquatic food establishment granted pursuant to Article 181(1) following an application made in accordance with Article 176, Article 177, point (a) of Article 178 or Article 179: (a) for which of the types of aquaculture establishments referred to in Article 176(1) and point (a) of Article 178, groups of aquaculture establishments referred to in Article 177 and disease control aquatic food establishments referred to in Article 179, and in any rules adopted pursuant to point (b) of Article 176(4), the approval applies; (b) for which species and categories of aquaculture animals the approval applies.
Article 183 Procedures for the granting of approval by the competent authority
1. The competent authority shall establish procedures for operators to follow when applying for approval of their establishments in accordance with Article 176(1) and Articles 178 and 179. 2. Upon receipt of an application for approval from an operator in accordance with Article 176(1), Article 178 or Article 179, the competent authority shall make an on–site visit. 3. Provided that the requirements referred to in Article 181 are fulfilled, the competent authority shall grant the approval. 4. Where an establishment does not fulfil all requirements for approval as referred to in Article 181, the competent authority may grant conditional approval of an establishment if it appears, on the basis of the application by the operator concerned and the subsequent on-site visit provided for in paragraph 2 of this Article, that the establishment meets all the main requirements that provide sufficient guarantees that the establishment does not pose a significant risk. 5. Where conditional approval has been granted by the competent authority in accordance with paragraph 4 of this Article, it shall grant full approval only where it appears from another on–site visit to the establishment, carried out within three months from the date of the grant of conditional approval, or from documentation provided by the operator within three months from that date, that the establishment meets all the requirements for approval provided for in Article 181(1) and the rules adopted pursuant to Article 181(2). Where the on–site visit or the documentation referred to in the first subparagraph shows that clear progress has been made but that the establishment still does not meet all of those requirements, the competent authority may prolong the conditional approval. However, conditional approval shall not be granted for a period exceeding, in total, six months.
Article 184 Review, suspension and withdrawal of approvals by the competent authority
1. The competent authority shall keep approvals of establishments granted in accordance with Article 181(1) under review, at appropriate intervals based on the risk involved. 2. Where a competent authority identifies serious deficiencies in an establishment as regards compliance with the requirements laid down in Article 181(1) and the rules adopted pursuant to Article 181(2), and the operator of that establishment is not able to provide adequate guarantees that those deficiencies will be eliminated, the competent authority shall initiate procedures to withdraw the approval of the establishment. However, the competent authority may merely suspend, rather than withdraw, approval of an establishment where the operator can guarantee that it will eliminate those deficiencies within a reasonable period of time. 3. Approval shall only be granted after withdrawal or restored after suspension in accordance with paragraph 2 when the competent authority is satisfied that the establishment fully complies with all the requirements of this Regulation appropriate for that type of establishment.
Article 185 Register of aquaculture establishments and disease control aquatic food establishments
1. Each competent authority shall establish and keep up to date a register of: (a) all aquaculture establishments registered in accordance with Article 173; (b) all aquaculture establishments approved in accordance with Article 181(1); (c) all disease control aquatic food establishments approved in accordance with Article 181(1). 2. The register of aquaculture establishments provided for in paragraph 1 shall contain the following information: (a) the name and address of the operator and the registration number of the establishment in question; (b) the location of the aquaculture establishment or, as the case may be, of the group of aquaculture establishments concerned; (c) the type of production at the establishment; (d) the water supply to, and discharge from, the establishment, when relevant; (e) the species of aquaculture animals kept at the establishment; (f) up–to–date information on the health status of the registered aquaculture establishment, or, as the case may be, of the group of establishments, as regards the listed diseases referred to in point (d) of Article 9(1). 3. For establishments approved in accordance with Article 181(1), the competent authority shall make publicly available by electronic means at least the information referred to in points (a), (c), (e) and (f) of paragraph 2 of this Article, subject to data protection requirements. 4. Where appropriate and relevant, a competent authority may combine the registration provided for in paragraph 1 with registration for other purposes. 5. The Commission shall adopt delegated acts in accordance with Article 264 concerning: (a) the relevant detailed information to be included in the register of aquaculture establishments provided for in paragraph 1 of this Article; (b) the public availability of that register.
Article 186 Record-keeping obligations of operators of aquaculture establishments
1. Operators of aquaculture establishments subject to the requirement of registration in accordance with Article 173, or approval in accordance with Article 181(1), shall keep and maintain records containing at least the following information: (a) the species, categories and quantities (numbers, volume or weight) of aquaculture animals on their establishment; (b) movements of aquaculture animals and products of animal origin obtained from those animals into and out of their establishment, stating as appropriate: (i) their place of origin or destination; (ii) the date of such movements; (c) the animal health certificates, in paper or electronic form, required to accompany movements of aquaculture animals arriving at the aquaculture establishment in accordance with Article 208 and the rules adopted pursuant to points (a) and (c) of Article 211(1) and Article 213(2); (d) mortality in each epidemiological unit and other disease problems at the aquaculture establishment as relevant for the type of production; (e) biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for: (i) the species and categories of the aquaculture animals on the establishment; (ii) the type of production at the aquaculture establishment; (iii) the type and size of the aquaculture establishment; (f) the results of any animal health visits required in accordance with Article 25(1). The records shall be kept and maintained in paper or electronic form. 2. Aquaculture establishments presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in points (c), (d) and (e) of paragraph 1, provided that traceability is ensured. 3. Operators of aquaculture establishments shall keep the records provided for in paragraph 1 on their aquaculture establishment concerned and shall: (a) keep them in such a way that the tracing of the place of origin and destination of aquatic animals can be guaranteed; (b) make them available to the competent authority on request; (c) retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years. By way of derogation from the requirement that the records are to be kept on their establishment concerned, as set out in the first subparagraph, when it is physically not possible to keep the records on that establishment, they shall be kept in the office from which the business is administered.
Article 187 Record-keeping obligations of disease control aquatic food establishments
1. Operators of disease control aquatic food establishments subject to approval in accordance with Article 179 shall keep and maintain records of: (a) all movements into and from their establishment of aquaculture animals and products of animal origin obtained from such animals; (b) discharge of water and relevant biosecurity measures. 2. Operators of disease control aquatic food establishments shall: (a) keep the records provided for in paragraph 1 on their establishment and shall make them available to the competent authority on request; (b) retain those records for a minimum period to be prescribed by the competent authority, which may not be less than three years. The records shall be kept and maintained in paper or electronic form.
Article 188 Record-keeping obligations of transporters
1. Transporters of aquatic animals intended for aquaculture establishments or to be released into the wild shall keep and maintain records in relation to: (a) the species, categories and quantities (numbers, volume or weight) of aquatic animals transported by them; (b) mortality rates of the aquaculture animals and wild aquatic animals in question during transport, in so far as is practicable for the type of transport and the species of aquaculture animals and wild aquatic animals transported; (c) aquaculture establishments and disease control aquatic food establishments visited by the means of transport; (d) any exchange of water that took place during transport, specifying the sources of new water and sites of release of water; (e) the cleaning and disinfection of the means of transport. The records shall be kept and maintained in paper or electronic form. 2. Transporters presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1, provided that traceability is ensured. 3. Transporters shall keep the records provided for in paragraph 1: (a) in such a manner that they can be made immediately available to the competent authority on request; (b) for a minimum period to be prescribed by the competent authority, which may not be less than three years.
Article 189 Delegation of powers concerning record-keeping
1. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules supplementing the record-keeping requirements provided for in Articles 186, 187 and 188, as regards information to be recorded by operators in addition to that provided for in Articles 186(1), 187(1) and 188(1). 2. The Commission shall take the following matters into account when adopting the delegated acts provided for in paragraph 1: (a) the risks posed by each type of aquaculture establishment or transport; (b) the species and categories of aquatic animals kept on the aquaculture establishment concerned, or transported to or from that establishment; (c) the type of production of the establishment; (d) typical movement patterns for the type of aquaculture establishment or disease control aquatic food establishment; (e) the numbers, volume or weight of aquatic animals kept on the establishment or transported to or from it.
Article 190 Implementing powers concerning exemptions from the record-keeping requirements
The Commission may, by means of implementing acts, lay down rules concerning the types of aquaculture establishments and operators that may be exempted by Member States from the record-keeping requirements provided for in Articles 186 and 188, as regards: (a) operators of certain categories of aquaculture establishments and transporters; (b) aquaculture establishments keeping, or transporters transporting, respectively, a small number of aquaculture animals or a small number of aquatic animals; (c) certain species and categories of aquatic animals. When adopting those implementing acts, the Commission shall base those acts on the criteria provided for in Article 189(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 191 General requirements for movements of aquatic animals
1. Operators shall take appropriate measures to ensure that the movement of aquatic animals does not jeopardise the health status at the place of destination with regard to: (a) the listed diseases referred to in point (d) of Article 9(1); (b) emerging diseases. 2. Operators shall only move aquatic animals into an aquaculture establishment or for human consumption purposes, or release them into the wild, if the animals in question fulfil the following conditions: (a) they come, except in the case of wild aquatic animals, from establishments that have been: (i) registered by the competent authority in accordance with Article 173, (ii) approved by that competent authority in accordance with Articles 181 and 182, when required by Article 176(1), Article 177 or Article 178, or (iii) granted a derogation from the registration requirement laid down in Article 173. (b) they are not subject to: (i) movement restrictions affecting the species and categories concerned in accordance with the rules laid down in Article 55(1), Article 56, Article 61(1), Articles 62, 64 and 65, point (b) of Article 70(1), Article 74(1), Article 79 and Article 81 and the rules adopted pursuant to Article 55(2), Articles 63 and 67 and Articles 70(3), 71(3), 74(4) and 83(2); or (ii) the emergency measures laid down in Articles 257 and 258 and the rules adopted pursuant to Article 259. However, operators may move those aquatic animals where derogations from the movement restrictions for such movements or release are provided for in Title II of Part III (Articles 53–83) or derogations from emergency measures are provided for in rules adopted pursuant to Article 259. 3. Operators shall take all necessary measures to ensure that aquatic animals, after leaving their place of origin, are consigned directly to the final place of destination.
Article 192 Disease prevention measures in relation to transport
1. Operators shall take the appropriate and necessary disease prevention measures to ensure that: (a) the health status of aquatic animals is not jeopardised during transport; (b) transport operations of aquatic animals do not cause the potential spread of listed diseases as referred to in point (d) of Article 9(1) to humans or animals en route, and at places of destination; (c) cleaning and disinfection of equipment and means of transport and other adequate biosecurity measures are taken, as appropriate to the risks involved with the transport operations concerned; (d) any exchanges of water and discharges of water during the transport of aquatic animals intended for aquaculture or release into the wild are carried out at places and under conditions which do not jeopardise the health status with regard to the listed diseases referred to in point (d) of Article 9(1) of: (i) the aquatic animals being transported; (ii) any aquatic animals en route to the place of destination; (iii) aquatic animals at the place of destination. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) the conditions and requirements for cleaning and disinfection of equipment and means of transport in accordance with point (c) of paragraph 1 of this Article and the use of biocidal products for such purposes; (b) other appropriate biosecurity measures during transport as provided for in point (c) of paragraph 1 of this Article; (c) water exchanges and discharges of water during transport as provided for in point (d) of paragraph 1 of this Article.
Article 193 Change of intended use
1. Aquatic animals which are moved for destruction or slaughter in accordance with the following measures shall not be used for any other purpose: (a) any of the disease control measures provided for in point (c) of Article 32(1) and Article 55(1), Articles 56, 61, 62, 64, 65 and 70, Articles 74(1) and (2) and Articles 79, 80, 81 and 82 and in the rules adopted pursuant to Article 55(2), Articles 63 and 67, Articles 70(3), 71(3) and 74(4), and Article 83(2); (b) emergency measures as provided for in Articles 257 and 258 and in rules adopted pursuant to Article 259. 2. Aquatic animals moved for human consumption, aquaculture, release into the wild or any other purpose, shall not be used for any purpose other than the intended one. 3. By way of derogation from paragraph 2, the competent authority of the place of destination may authorise a change of use of aquatic animals for a purpose other than that originally intended, provided that the new use does not pose a higher risk to the health status of the aquatic animals at the place of destination than the originally intended use.
Article 194 Obligations of operators at the place of destination
1. Operators of aquaculture establishments and disease control aquatic food establishments receiving aquatic animals and operators receiving aquatic animals for release into the wild shall, before the aquatic animals are unloaded: (a) check that, where required, one of the following documents is present: (i) the animal health certificates provided for in Article 208(1), Article 209 and Article 223(1) and in the rules adopted pursuant to Articles 189, 211 and 213; (ii) the self–declaration documents provided for in Article 218(1) and in the rules adopted pursuant to Article 218(3) and (4); (b) inform the competent authority of the place of destination, after checking the aquatic animals received, of any irregularity with regard to: (i) the aquatic animals received; (ii) the documents referred to in point (a)(i) and (ii). 2. In the event of any irregularity as referred to in point (b) of paragraph 1, the operator shall isolate the aquatic animals concerned by that irregularity until the competent authority of the place of destination has taken a decision regarding them.
Article 195 General requirements in respect of movements of aquaculture animals passing through Member States but intended for export from the Union to third countries or territories
Operators shall ensure that aquaculture animals intended for export to a third country or territory and passing through the territory of another Member State fulfil the requirements laid down in Articles 191, 192 and 193.
Article 196 Abnormal mortalities or other serious disease symptoms
1. Operators shall only move aquatic animals from an aquaculture establishment or from the wild to another aquaculture establishment, or release them into the wild, if the animals in question: (a) show no disease symptoms; and (b) originate from an aquaculture establishment or environment where there are no abnormal mortalities with an undetermined cause. 2. By way of derogation from paragraph 1, the competent authority may, on the basis of an evaluation of the risks involved, authorise the movement or release of aquatic animals as referred to in that paragraph, provided that the animals in question originate from a part of the aquaculture establishment or from the wild that is independent of the epidemiological unit where the abnormal mortalities or other disease symptoms have occurred. If the movement or release referred to in this paragraph is to be made to another Member State, it shall only be authorised by the competent authority if the competent authorities of the Member State of destination and, where relevant, of the Member States of passage have given their consent to such movement or release.
Article 197 Movements of aquaculture animals intended for Member States, zones or compartments which have been declared disease-free or which are subject to an eradication programme, and delegated acts
1. Operators shall only move aquaculture animals of listed species relevant for one or more of the listed diseases referred to in points (b) or (c) of Article 9(1) to an aquaculture establishment, or for release into the wild, in a Member State, zone or compartment which has been declared free of those listed diseases in accordance with Article 36(4) or 37(4), if the animals in question originate from a Member State, or a zone or compartment thereof, which has been declared free of those diseases. 2. Operators shall only move aquaculture animals of listed species relevant for one or more of the listed diseases referred to in points (b) or (c) of Article 9(1) to an aquaculture establishment, or for release into the wild, in a Member State, zone or compartment subject to an eradication programme for one or more of those listed diseases as provided for in Article 31(1) or (2), if the animals in question originate from a Member State, or a zone or compartment thereof, which has been declared free of those listed diseases. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations from the movement or release requirements laid down in paragraphs 1 and 2 of this Article which do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) on account of: (a) the species, categories, and life stage of the aquaculture animals concerned; (b) the type of establishment of origin and of destination; (c) the intended use of the aquaculture animals; (d) the place of destination of the aquaculture animals; (e) treatments, processing methods and other special risk-mitigation measures applied at the place of origin or destination.
Article 198 Derogations by Member States concerning the obligation of operators for movement of aquaculture animals between Member States, zones or compartments which are subject to an eradication programme
By way of derogation from Article 197(1) and (2), Member States may authorise operators to move aquaculture animals into a zone or compartment for which an eradication programme has been established in accordance with Article 31(1) and (2) as regards the listed diseases referred to in points (b) and (c) of Article 9(1), from another zone or compartment for which such a programme has also been established for the same listed diseases, provided that such movement will not jeopardise the health status of the Member State, zone or compartment of destination. If such movements are to be made to another Member State, the competent authority shall only authorise them if the competent authorities of the Member State of destination and, where relevant, of the Member States of passage, have given their consent to them.
Article 199 Member States' measures concerning the release of aquatic animals into the wild
Member States may require that aquatic animals may be released into the wild only if they originate from a Member State, or a zone or compartment thereof, which has been declared disease–free in accordance with Article 36(1) or Article 37(1) as regards one or more of the listed diseases referred to in points (b) and (c) of Article 9(1) for which the species of aquatic animals to be moved is a listed species, regardless of the health status of the area where those aquatic animals are to be released.
Article 200 Movements of wild aquatic animals intended for Member States, or zones or compartments thereof, which have been declared disease–free or which are subject to an eradication programme, and delegated acts
1. Articles 196, 197 and 198 shall apply to movements of wild aquatic animals intended for an aquaculture establishment or for release into the wild. 2. Operators shall take the appropriate and necessary disease prevention measures when moving wild aquatic animals between habitats to ensure that: (a) such movements do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to aquatic animals at the place of destination; and (b) risk-mitigation or other adequate biosecurity measures are in place where necessary to ensure compliance with point (a). 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the disease prevention and risk-mitigation measures to be taken by operators as provided for in paragraph 2 of this Article. Pending the adoption of such delegated acts, the competent authority of the place of destination may decide on such measures.
Article 201 Movements of live aquaculture animals intended for human consumption in Member States, or in zones or compartments thereof, which have been declared disease–free or which are subject to an eradication programme, and delegated acts
1. Operators shall only move live aquaculture animals of listed species relevant for listed diseases as referred to in points (b) or (c) of Article 9(1) intended for human consumption to a Member State, or to a zone or compartment thereof, which has been declared disease-free in accordance with Article 36(4) or Article 37(4) or for which a eradication programme has been established in accordance with Article 31(1) or (2), as regards one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), if the animals in question originate from a Member State, or a zone or compartment thereof, which has been declared disease–free in accordance with Article 36(4) or Article 37(4). 2. By way of derogation from paragraph 1 of this Article, Member States may authorise operators to introduce live aquaculture animals into a zone or compartment for which an eradication programme has been established in accordance with Article 31(1) or (2) as regards the listed diseases referred to in points (b) and (c) of Article 9(1), from another zone or compartment for which such a programme has also been established as regards the same diseases within that Member State, provided that such movement will not jeopardise the health status of the Member State or of the zone or compartment thereof. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the derogations provided for in paragraph 2 of this Article in respect of movements of live aquaculture animals which do not pose a significant risk of spreading of diseases on account of: (a) the species, categories, and live stage of the aquaculture animals concerned; (b) the methods of keeping the aquaculture animals and the type of production in the aquaculture establishments of origin and of destination; (c) the intended use of the aquaculture animals; (d) the place of destination of the aquaculture animals; (e) treatments, processing methods and other special risk-mitigation measures applied at the place of origin or the place of destination.
Article 202 Movements of live wild aquatic animals intended for Member States, or zones or compartments thereof, which have been declared disease–free or which are subject to an eradication programme, and delegated acts
1. Article 201(1) and (2) and the rules adopted pursuant to Article 201(3) shall apply to movements of live wild aquatic animals intended for human consumption and which are intended for Member States, or zones or compartments thereof, which have been declared disease–free in accordance with Articles 36(4) or 37(4) or which are subject to an eradication programme in accordance with Article 31(1) or (2), where the measures adopted pursuant thereto are necessary in order to ensure that the animals in question do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to aquatic animals at the place of destination. 2. Paragraph 1 of this Article shall also apply to live aquatic animals not covered by the definition of aquaculture animals contained in Article 4(7). 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning movement requirements for wild aquatic animals intended for human consumption, supplementing paragraphs 1 and 2 of this Article.
Article 203 Aquatic animals intended for confined establishments for aquaculture and delegated acts
1. Operators shall only move aquatic animals to a confined establishment for aquaculture if the animals in question fulfil the following conditions: (a) they originate from another confined establishment for aquaculture; (b) they do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to listed species of animals at the confined establishment for aquaculture of destination, except where the movement in question is authorised for scientific purposes. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) detailed rules for movements of aquaculture animals to confined establishments for aquaculture in addition to those provided for in paragraph 1 of this Article; (b) specific rules for movements of aquaculture animals to confined establishments for aquaculture where the risk-mitigation measures in place guarantee that such movements do not pose a significant risk for the health of aquaculture animals within that confined establishment for aquaculture and the surrounding establishments.
Article 204 Movements of aquatic animals for scientific purposes and delegated acts
1. The competent authority of the place of destination may, subject to the agreement of the competent authority of the place of origin, authorise movements of aquatic animals into the territory of the Member State of destination, for scientific purposes, where those movements do not fulfil the requirements of Sections 1 to 3 (Articles 191 to 202), with the exception of Article 191(1) and (3) and Articles 192, 193 and 194. 2. The competent authority referred to in paragraph 1 shall only grant derogations as provided for in that paragraph under the following conditions: (a) the competent authorities of the places of destination and origin: (i) have agreed on the conditions for such movements; (ii) ensure that the necessary risk-mitigation measures are in place so that movements of the aquatic animals in question do not jeopardise the health status in places en route and in the places of destination with regard to the listed diseases referred to in point (d) of Article 9(1); (iii) have notified, where relevant, the competent authorities of the Member States of passage of the derogation granted and of the conditions under which it is granted; (b) those movements take place under the supervision of the competent authorities of the places of origin and destination, and where relevant, the competent authorities of the Member States of passage. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules for the granting of derogations by competent authorities, supplementing those provided for in paragraphs 1 and 2 of this Article.
Article 205 Other specific uses of aquatic animals, specific requirements and derogations and delegation of powers
1. Operators shall take the necessary preventive measures to ensure that movements of aquatic animals intended for the specific purposes or uses listed in point (a)(i) to (vi) of paragraph 2 of this Article do not pose a risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to aquatic animals at the place of destination. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) specific requirement supplementing the rules laid down in Sections 1 to 3 (Articles 191 to 202) and for movements of aquatic animals for the following purposes: (i) zoos, pet shops, wholesalers and garden ponds; (ii) exhibitions; (iii) sports fishing, including fishing baits; (iv) cultural and similar events; (v) commercial aquaria; or (vi) health care and other similar uses. (b) derogations from Sections 1 to 3 (Articles 191 to 202) with the exception of Article 191(1) and (3) and Articles 192, 193 and 194 for the movements of aquatic animals referred to in point (a) of this paragraph, provided that adequate biosecurity provisions are in place to ensure that those movements do not pose a significant risk to the health status of the place of destination.
Article 206 Implementing power to adopt temporary rules for movements of specific species or categories of aquatic animals
1. The Commission may, by means of implementing acts, lay down temporary rules, by way of addition or alternative to those laid down in this Chapter, for movements of specific species or categories of aquatic animals where: (a) the movement requirements provided for in Article 196, Article 197(1), Articles 198 and 199, Article 200(1) and (2), Article 201 and Articles 202(1), 203(1), 204(1) and (2) and the rules adopted pursuant to Articles 197(3), 200(3), 202(3), 203(2) and 204(3) and Article 205 do not efficiently mitigate the risks posed by the movement of those aquatic animals; or (b) a listed disease as referred to in point (d) of Article 9(1) appears to be spreading despite the movement requirements laid down in accordance with Sections 1 to 4 (Articles 191 to 207). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2). 2. On duly justified imperative grounds of urgency relating to a listed disease representing a risk of a highly significant impact and taking into account the matters referred to in Article 205, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).
Article 207 Matters to be taken into account in the adoption of delegated and implementing acts as provided for in this Section
When establishing the rules to be laid down in the delegated and implementing acts provided for in Article 203(2), Article 204(3) and Articles 205 and 206, the Commission shall base those rules on: (a) the risks involved with the movements referred to in those provisions; (b) the health status as regards the listed diseases referred to in point (d) of Article 9(1) at the places of origin, passage and destination; (c) listed aquatic animal species for the listed diseases referred to in point (d) of Article 9(1); (d) biosecurity measures in place at the places of origin, passage and destination; (e) any specific conditions under which the aquaculture animals are kept; (f) specific movement patterns of the type of aquaculture establishment and the species or category of aquatic animals concerned; (g) other epidemiological factors.
Article 208 Obligation of operators to ensure that aquaculture animals are accompanied by an animal health certificate
1. Operators shall only move aquaculture animals if they are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 216(1), where the animals in question are of listed species for the listed diseases referred to in points (b) and (c) of Article 9(1) and are intended for introduction into a Member State, or a zone or compartment thereof, which has been declared disease–free in accordance with Articles 36(4) and 37(4) or for which an eradication programme has been established as provided for in Article 31(1) or (2) as regards one or more of the listed diseases referred to in points (b) and (c) of Article 9(1). 2. Operators shall only move aquaculture animals if they are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 216(1), where the animals in question are of listed species for the relevant disease(s) referred to in points (a) and (b) of Article 9(1) and are allowed to leave a restricted zone subject to disease control measures as provided for in point (f)(ii) of Article 55(1), Articles 56 and 64 or Articles 65(1), 74(1), 79 and rules adopted pursuant to Article 55(2), Articles 67 and 68, Articles 71(3), 74(4) and 83(2) and Article 259 for one or more of the listed diseases referred to in points (a) and (b) of Article 9(1). 3. Operators shall take all necessary measures to ensure that the animal health certificate accompanies the aquaculture animals from their place of origin to their final place of destination, unless specific measures are provided for in rules adopted pursuant to Article 214.
Article 209 Obligation of operators to ensure that other aquatic animals are accompanied by an animal health certificate and implementing power
1. In cases where, due to the risk involved with the movement of aquatic animals other than aquaculture animals, animal health certification is required in accordance with the rules provided for in point (a) of Article 211(1), operators shall only move those aquatic animals if the animals in question are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 216(1). 2. Article 208 shall also apply to aquatic animals other than aquaculture animals intended for an aquaculture establishment or release into the wild. Where the competent authority of the Member State of origin concludes that certification is not feasible due to the nature of the place of origin of the aquatic animals in question, it may authorise their movement without an animal health certificate subject to the consent of the competent authority of the place of destination. 3. This Article shall not apply to wild aquatic animals harvested or caught for direct human consumption.
Article 210 Grant of derogations by Member States in respect of national animal health certification
By way of derogation from the animal health certification requirements laid down in Articles 208 and 209, Member States may grant derogations for movements of certain consignments of aquatic animals without an animal health certificate within their territories provided that they have in place an alternative system to ensure that consignments of such animals are traceable and those consignments comply with the animal health requirements for such movements provided for in Sections 1 to 4 (Articles 191 to 207).
Article 211 Delegation of powers and implementing acts concerning animal health certification in respect of aquatic animals
1. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) the requirement for animal heath certification for movements of aquatic animals other than aquaculture animals as referred to in Article 209(1), in cases where animal health certification is imperative in order to ensure that the movement in question complies with the following animal health requirements for the listed species of animals concerned: (i) the requirements provided for in Sections 1 to 4 (Articles 191 to 207) and the rules adopted pursuant to those Sections; (ii) disease control measures as provided for in Article 55(1), Article 56, Article 61(1), Articles 62 and 64, and Article 65(1), Article 74(1), and Articles 79 and 80 or the rules adopted pursuant to Article 55(2), Articles 63, 67 and 68, and Articles 71(3), 74(4) and 83(2); (iii) emergency measures as provided for in the rules adopted pursuant to Article 259; (b) special rules for animal health certification as provided for in Articles 208 and 209 where specific risk-mitigation measures are taken by the competent authority to ensure: (i) the traceability of the aquatic animals being moved; (ii) that the aquatic animals being moved fulfil the animal health requirements for movements provided for in Sections 1 to 4 (Articles 191 to 207); (c) derogations from the animal health certificate requirements provided for in Articles 208 and 209 and the conditions for such derogations for movements of aquatic animals which do not pose a significant risk of the spread of diseases, on account of: (i) species, the categories or live stage of the aquatic animals concerned; (ii) the methods of keeping and the type of production of those species and categories of aquaculture animals; (iii) the intended use of the aquatic animals; or (iv) the place of destination of the aquatic animals. 2. The Commission shall, by means of implementing acts, lay down rules concerning the obligation of operators, as provided for in Article 209(2), to ensure that wild aquatic animals intended for an aquaculture establishment are accompanied by an animal health certificate. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 212 Contents of animal health certificates
1. The animal health certificate referred to in Articles 208, 209 and 210 shall contain at least the following information: (a) the establishment or place of origin, the establishment or place of destination and, where relevant for the spread of diseases, any establishment or place visited en route; (b) a description, including the species and category, of the aquatic animals concerned; (c) the quantity (number, volume or weight) of aquatic animals; (d) the information needed to demonstrate that the aquatic animals fulfil the relevant animal health requirements in respect of movements provided for in Sections 1 to 4 (Articles 191 to 207). 2. The animal health certificate may include other information required under other Union legislation.
Article 213 Delegation of powers and implementing acts concerning the content of animal health certificates
1. The Commission shall adopt delegated acts in accordance with Article 264 concerning the content of animal health certificates as provided for in Article 212(1): (a) detailed rules on the content of those animal health certificates provided for in Article 212(1) for different species and categories of aquatic animals; (b) additional information to be contained in the animal health certificate provided for in Article 212(1). 2. The Commission may, by means of implementing acts, lay down rules concerning the model forms for the animal health certificates. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 214 Delegation of powers concerning specific types of movements of aquatic animals to the place of destination
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning specific measures supplementing the requirements for animal health certification provided for in Article 208 and 209 for the following types of movements of aquatic animals: (a) movements of aquatic animals which are required to return to their place of origin or to be moved to a different destination, for one or more of the following reasons: (i) their intended journey was unexpectedly interrupted for animal welfare reasons; (ii) unforeseen accidents or events during the journey; (iii) they were rejected at the place of the destination in another Member State or at the external border of the Union; (iv) they were rejected in a third country or territory; (b) movements of aquaculture animals intended for exhibitions and for sporting, cultural and similar events, and their subsequent return to their place of origin.
Article 215 Operators' obligations to cooperate with the competent authorities for the purposes of animal health certification
Operators shall: (a) provide the competent authority with all the information necessary to complete the animal health certificate provided for in Articles 208 and 209 and in the rules adopted pursuant to Articles 211, 213 and 214, in advance of the intended movement; (b) where necessary, ensure that the aquatic animals in question are subjected to documentary, identity and physical checks as provided for in Article 216(3) and in the rules adopted pursuant to Article 216(4).
Article 216 Responsibility of the competent authority for animal health certification and delegated acts
1. The competent authority shall, upon request by an operator, issue an animal health certificate for the movement of aquatic animals, where required by Articles 208 and 209, or by rules adopted pursuant to Articles 211 and Article 214, provided that the following animal health requirements have been complied with, as relevant: (a) those provided for in Article 191, Article 192(1), Articles 193, 195 and 196, Article 197(1), Articles 198 and 199, Article 200(1) and (2), Article 201, Article 203(1) and Article 204(1) and (2); (b) those provided for in delegated acts adopted pursuant to Articles 192(2), 197(3), 200(3), 201(3), 202(3), 203(2) and 204(3) and Article 205; (c) those provided for in implementing acts adopted pursuant to Article 206. 2. Animal health certificates shall: (a) be verified, stamped and signed by an official veterinarian; (b) remain valid for the period of time, provided for in the rules adopted pursuant to point (c) of paragraph 4, during which the aquatic animals covered by it must continue to fulfil the animal health guarantees contained in it. 3. Before signing an animal health certificate, the official veterinarian concerned shall verify, by means of documentary, identity and physical checks as provided for by delegated acts adopted pursuant to paragraph 4 where appropriate, that the aquatic animals covered by it fulfil the requirements of this Chapter, taking into account the species and categories of aquatic animals concerned and the animal health requirements. 4. The Commission shall adopt delegated acts in accordance with Article 264 laying down rules concerning: (a) the types of documentary, identity and physical checks and examinations in relation to different species and categories of aquatic animals that must be carried out by the official veterinarian in accordance with paragraph 3 in order to verify compliance with the requirements of this Chapter; (b) the timeframes for the carrying-out of such documentary, identity and physical checks and examinations, and the issuing of animal health certificates by the official veterinarian prior to the movement of consignments of aquatic animals; (c) the duration of the validity of animal health certificates.
Article 217 Electronic animal health certificates
Electronic animal health certificates, produced, handled and transmitted by means of Traces, may replace accompanying animal health certificates as provided for in Article 216(1) where such electronic animal health certificates: (a) contain all the information that the model form of animal health certificate is required to contain in accordance with Article 212(1) and the rules adopted pursuant to Article 213; (b) ensure the traceability of the aquatic animals in question and the link between those animals and the electronic animal health certificate; (c) ensure that the competent authorities of the Member States of origin, passage and destination are able to have access to the electronic documents at all times during the transport.
Article 218 Self–declaration by operators for movements of aquaculture animals to other Member States and delegated acts
1. Operators at the place of origin shall issue a self–declaration document for movements of aquaculture animals from their place of origin in one Member State to their place of destination in another Member State, and shall ensure that it accompanies such aquaculture animals, where they are not required to be accompanied by an animal health certificate as provided for in Articles 208 and 209 or in any rules adopted pursuant to Articles 211 and Article 214. 2. The self–declaration document provided for in paragraph 1 shall contain at least the following information concerning the aquaculture animals in question: (a) their places of origin and destination, and, when relevant, any places en route; (b) the means of transport (c) a description of the aquaculture animals, and their categories, species and quantity (numbers, volume or weight), as relevant for the animals concerned; (d) the information needed to demonstrate that the aquaculture animals fulfil the movement requirements provided for in Sections 1 to 4 (Articles 191 to 207). 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) detailed rules on the content of the self–declaration document provided for in paragraph 2 of this Article for different species and categories of aquaculture animals; (b) additional information to be contained in the self–declaration document to the one provided for in paragraph 2 of this Article. 4. The Commission may, by means of implementing acts, lay down rules for a model form of the self–declaration document provided for in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 219 Obligation of operators concerning the notification of movements of aquatic animals to other Member States
1. Operators other than transporters shall notify the competent authority in their Member State of origin in advance of intended movements of aquatic animals from one Member State to another Member State where: (a) the aquatic animals are required to be accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Articles 208 and 209 and any rules adopted pursuant to Article 211 and Article 214(2); (b) the aquatic animals are required to be accompanied by an animal health certificate for aquatic animals when they are being moved from a restricted zone as referred to in Article point (a) of 208(2); (c) the aquaculture animals and wild aquatic animals being moved are intended for: (i) an establishment subject to registration in accordance with Article 173 or approval in accordance with Articles 176 to 179; (ii) release into the wild; (d) notification is required in accordance with delegated acts adopted pursuant to Article 221. 2. For the purposes of the notification provided for in paragraph 1 of this Article, operators shall provide the competent authority of their Member State of origin with all the necessary information to enable it to notify the movement to the competent authority of the Member State of destination in accordance with Article 220(1).
Article 220 Responsibility of the competent authority to notify movements of aquatic animals to other Member States
1. The competent authority of the Member State of origin shall notify the competent authority of the Member State of destination of movements of aquatic animals as referred to in Article 219, unless a derogation has been granted in accordance with point (c) of Article 221(1) as regards such notification. 2. The notification referred to in paragraph 1 shall be carried out prior to the movement in question and, whenever possible, through Traces. 3. Member States shall designate regions for the management of notifications of movements as provided for in paragraph 1. 4. By way of derogation from paragraph 1, the competent authority of Member State of origin may authorise the operator concerned to notify, partially or completely, movements of aquatic animals through Traces to the competent authority of the Member State of destination.
Article 221 Delegation of powers and implementing acts for the notification of movements of aquatic animals by operators and by the competent authority
1. The Commission shall adopt delegated acts in accordance with Article 264 concerning: (a) the requirement for advance notification by operators, in accordance with Article 219, of movements between Member States of aquatic animals of species or categories other than those referred to in points (a), (b) and (c) of Article 219(1), where traceability of such movements is necessary in order to ensure compliance with the animal health requirements laid down in this Chapter; (b) the information needed in order to notify movements of aquatic animals as provided for in Articles 219 and 220(1); (c) derogations from the notification requirements provided for in point (c) of Article 219(1) for species and categories of aquatic animals or types of movements which pose an insignificant risk; (d) the emergency procedures for notification of movements of aquatic animals in the event of power cuts or other disturbances of Traces; (e) the requirements for the designation of regions by Member States as provided for in Article 220(3). 2. The Commission may, by means of implementing acts, lay down rules concerning: (a) the details of notifications by: (i) operators to the competent authority of the Member State of origin of movements of aquatic animals in accordance with Article 219; (ii) the competent authority of the Member State of origin to the Member State of destination of movements of aquatic animals in accordance with Article 220(1); (b) the deadlines for: (i) the provision by operators of the necessary information referred to in Article 219(2) to the competent authority of the Member State of origin; (ii) the notification of movements by the competent authority of the Member State of origin as referred to in Article 220(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 222 General animal health obligations for operators and delegated acts
1. Operators shall take appropriate preventive measures to ensure that, during all stages of the production, processing and distribution of products of animal origin from aquatic animals, other than live aquatic animals, those products do not cause the spread of: (a) listed diseases as referred to in point (d) of Article 9(1), taking into account the health status of the place of production, processing and destination; (b) emerging diseases. 2. Operators shall ensure that products of animal origin from aquatic animals, other than live aquatic animals, do not come from establishments or food businesses, or are not obtained from animals which come from such establishments or food businesses, that are subject to: (a) emergency measures as provided for in Articles 257 and 258 and any rules adopted pursuant to Article 259, unless derogations have been provided for in respect of those rules in Part VII (Articles 257 to 262); (b) movement restrictions applicable to aquatic animals and products of animal origin from aquatic animals, as provided for in point (c) of Article 32(1), point (e) of Article 55(1), Article 56, point (a) of Article 61(1), Article 62(1), point (c) of Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1), point (b) of Article 76(2), Article 76(3), Article 79, Article 81 and Article 82(2) and (3) and the rules adopted pursuant to Article 55(2), Articles 63 and 67, and Articles 70(3), 71(3), 74(4), 76(5) and 83(2), unless derogation from those movement restrictions have been provided for in those rules. 3. The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed requirements supplementing those referred to in paragraph 2 of this Article in relation to movements of products of animal origin from aquatic animals other than live aquatic animals, as regards: (a) the diseases, and species of aquatic animals concerned by the diseases, for which emergency measures or movement restrictions as referred to in paragraph 2 of this Article apply; (b) the types of products of animal origin from aquatic animals; (c) the risk-mitigation measures applied to the products of animal origin from aquatic animals at the places of origin and destination; (d) the intended use of the products of animal origin from aquatic animals; (e) the place of destination of the products of animal origin from aquatic animals. 4. This Article shall not apply to products of animal origin from wild aquatic animals harvested or caught for direct human consumption.
Article 223 Animal health certificates and delegated acts
1. Operators shall only move the following products of animal origin from aquatic animals other than live aquatic animals where those products are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with paragraph 3: (a) products of animal origin from aquatic animals that: (i) are allowed to leave a restricted zone subject to emergency measures as provided for in rules adopted pursuant to Article 259; and (ii) originate from aquatic animals of species subject to those emergency measures; (b) products of animal origin from aquatic animals that: (i) are allowed to leave a restricted zone subject to disease control measures in accordance with point (c) of Article 32(1), point (c) of Article 55(1), Article 56, point (a) of Article 61(1), Articles 62(1) and 63(1), point (c) of Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1) and Article 79 and the rules adopted pursuant to Article 55(2), Articles 63 and 67 and Articles 71(3), 74(4) and 83(2); and (ii) originate from aquatic animals of species subject to those disease control measures. 2. By way of derogation from paragraph 1, such a certificate shall not be required for movements of products of animal origin from wild aquatic animals, provided that: (a) alternative risk-mitigation measures authorised by the competent authority are in place to ensure that those movements do not pose a risk of the spread of listed diseases; (b) consignments of such products are traceable. 3. 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. 4. The competent authority shall, upon request by the operator concerned, issue an animal health certificate for movements of products of animal origin other than live aquatic animals as referred to in paragraph 1, provided that the relevant requirements referred to in this Article have been complied with. 5. Article 212 and Articles 214 to 217 and the rules adopted pursuant to Article 213 and Article 216(4) shall apply to the animal health certification of movements of products of animal origin other than live aquatic animals as referred to in paragraph 1 of this Article. 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning requirements and detailed rules on the animal health certificate to accompany products of animal origin other than live aquatic animals, as referred to in paragraph 1 of this Article, taking into account: (a) the types of products of animal origin concerned; (b) the risk-mitigation measures applied to the products concerned which reduce the risks of the spread of diseases; (c) the intended use of those products; (d) the place of destination of those products.
Article 224 Content of animal health certificates and delegated and implementing acts
1. The animal health certificate for products of animal origin from aquatic animals, other than live aquatic animals, shall contain at least the following information: (a) the establishment or place of origin and the establishment or place of destination; (b) a description of the products of animal origin concerned; (c) the quantity (numbers, volume or weight) of the products of animal origin; (d) the identification of the products of animal origin, when required by point (h) of Article 65(1) or by any rules adopted pursuant to Article 67; (e) the information needed to demonstrate that the products concerned fulfil the movement restriction requirements provided for in Article 222(2) and in any rules adopted pursuant to Article 222(3). 2. The animal health certificate referred to in paragraph 1 may include other information required under other Union legislation. 3. The Commission shall adopt delegated acts in accordance with Article 264 concerning amending and supplementing the information to be contained in the animal health certificate as provided for in paragraph 1 of this Article. 4. The Commission may, by means of implementing acts, lay down rules concerning model forms of animal health certificates as provided for 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 225 Notification of movements of products of animal origin to other Member States
1. Operators shall: (a) inform the competent authority in the Member State of origin in advance of intended movements of products of animal origin from aquatic animals, other than live aquatic animals, when the consignments in question are required to be accompanied by an animal health certificate in accordance with Article 223(1); (b) provide all necessary information to enable the competent authority of the Member State of origin to notify the movement in question to the Member State of destination in accordance with paragraph 2 of this Article. 2. The competent authority of the Member State of origin shall notify the competent authority of the Member State of destination of movements of products of animal origin from aquatic animals, other than live aquatic animals, in accordance with Article 220(1). 3. Articles 219 and 220 and any rules adopted pursuant to Article 221 shall be applicable to the notification of products of animal origin from aquatic animals, other than live aquatic animals.
Article 226 National measures designed to limit the impact of diseases other than listed disease
1. Where a disease other than a listed disease as referred to in point (d) of Article 9(1) constitutes a significant risk for the health of aquatic animals in a Member State, the Member State concerned may take national measures to prevent the introduction, or to control the spread, of that disease. Member States shall ensure that those national measures do not exceed the limits of what is appropriate and necessary in order to prevent the introduction, or to control the spread, of the disease in question within the Member State concerned. 2. Member States shall notify the Commission in advance of any proposed national measures as referred to in paragraph 1 that may affect movements of aquatic animals and products of animal origin from aquatic animals between Member States. 3. The Commission shall approve and, if necessary, amend the national measures referred to in paragraph 2 of this Article by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2). 4. The approval referred to in paragraph 3 shall only be granted where the establishment of movement restrictions between Member States is necessary in order to prevent the introduction, or to control the spread, of the disease referred to in paragraph 1, taking into account the overall impact on the Union of the disease in question and of the measures taken.
Article 227 Animal health requirements concerning other animals, and germinal products and products of animal origin of such other animals
Where other animals are of a listed species for a listed disease as referred to in point (d) of Article 9(1), and those other animals or their germinal products or products of animal origin represent a risk to public or animal health in the Union, one or more of the following requirements shall apply: (a) the requirements concerning registration, approval, record-keeping and registers for establishments and transporters provided for in Chapter 1 of Title I and Chapter 1 of Title II (Articles 84 to 101 and Articles 172 to 175); (b) the requirements concerning traceability provided for in Articles 108 to 111 and Article 117 for other animals and Article 122 for germinal products; (c) movement requirements: (i) as regards other animals mainly living in a terrestrial environment or that are normally affected by diseases of terrestrial animals, taking into account the criteria provided for in points (d) and (e) of Article 228(3), the requirements provided for in Section 1 (Articles 124 and 125) and Section 6 of Chapter 3 of Title I of Part IV (Articles 137 to 142) and Chapter 4 of Title I of Part IV (Articles 155 and 156); (ii) as regards other animals mainly living in aquatic environment or that are normally affected by diseases of aquatic animals, taking into account the criteria provided for in points (d) and (e) of Article 228(3), the requirements provided for in Sections 1 to 4 of Chapter 2 of Title II of Part IV (Articles 191 to 207); (iii) as regards germinal products, the general requirements for movements provided for in Articles 157 and 158 and the special requirements for movements to other Member States provided for in Articles 164 and 165; (iv) as regards products of animal origin, the general animal health obligations incumbent on operators in respect of the production, processing and distribution within the Union of products of animal origin provided for in Articles 166 and 222; (d) the animal health certification obligation incumbent on operators and competent authorities and the self–declaration incumbent on operators: (i) as regards other animals, pursuant to the rules provided for in Articles 143 to 151 or Articles 208 to 218; (ii) as regards germinal products, pursuant to the rules provided for in Articles 161 and 162; (iii) as regards products of animal origin, pursuant to the rules provided for in Articles 165 and 168 or Articles 223 and 224; (e) the obligation to notify movements incumbent on operators and competent authorities, taking into account the requirements provided for in Articles 152, 153, 154, 163 and 169 and in Articles 219 to 221 and 225.
Article 228 Delegation of powers and implementing acts concerning animal health requirements for other animals, and germinal products and products of animal origin of other animals
1. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning any specific requirements for other animals, and their germinal products or products of animal origin, which are necessary in order to mitigate the risk of the listed diseases referred to in point (d) of Article 9(1), as provided for in Article 227. 2. The Commission may adopt implementing acts concerning detailed rules for the implementation of the disease control and prevention measures provided for in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2). 3. When adopting the delegated acts and implementing acts provided for in paragraphs 1 and 2, the Commission shall base those acts on the following criteria: (a) the species or categories of other animals listed in accordance with Article 8(2) as listed species for one or more listed diseases, for which certain disease prevention and control measures provided for in this Regulation apply; (b) the profile of the listed disease in question, which concerns species and categories of other animals referred to in point (a); (c) the feasibility, availability and effectiveness of disease prevention and control measures for the listed species concerned by those measures; (d) the prevailing terrestrial or aquatic living environment of those other animals; (e) the types of diseases that are affecting such other animals, which can be either diseases normally affecting terrestrial or aquatic animals, regardless of the prevailing living environment referred to in point (d).
Article 229 Requirements for entry into the Union of animals, germinal products and products of animal origin
1. Member States shall permit the entry into the Union of consignments of animals, germinal products and products of animal origin from third countries or territories only if those consignments fulfil the following requirements, unless such animals, germinal products or products of animal origin are covered by a derogation granted pursuant to Article 239(2): (a) without prejudice to Article 230(2), they come from a third country or territory listed in accordance with Article 230(1) for the particular species and category of animals, or germinal products or products of animal origin concerned, or from a zone or compartment thereof; (b) they come from establishments which are approved and listed, where such approval and listing is required by Article 233; (c) they fulfil the animal health requirements for entry into the Union laid down in Article 234(1) and in any delegated acts adopted pursuant to Article 234(2), where such requirements are laid down for the animal, germinal product or product of animal origin concerned; (d) they are accompanied by an animal health certificate and by declarations and other documents where required by Article 237(1) or by rules adopted pursuant to Article 237(4); 2. The operators responsible for the consignment in question shall present consignments of animals, germinal products and products of animal origin from third countries or territories for the purposes of official control as provided for in Article 3 of Directive 91/496/EEC and Article 3 of Directive 97/78/EC.
Article 230 Lists of third countries and territories from which the entry into the Union of animals, germinal products and products of animal origin is permitted, and implementing and delegated acts
1. The Commission may, by means of implementing acts, draw up lists of third countries and territories from which the entry into the Union of specific species and categories of animals, germinal products and products of animal origin is to be permitted, based on the following criteria: (a) the animal health legislation of the third country or territory concerned and the rules on the entry into that third country or territory of animals, germinal products and products of animal origin from other third countries and territories; (b) the assurances provided by the competent authority of the third country or territory concerned as regards the efficient implementation and control of the animal health legislation referred to in point (a); (c) the organisation, structure, resources and legal powers of the competent authority in the third country or territory concerned; (d) the animal health certification procedures in the third country or territory concerned; (e) the animal health status of the third country or territory concerned, or of zones and compartments thereof, with regard to: (i) listed diseases and emerging diseases; (ii) any aspects of animal and public health or the environmental situation in the third country or territory concerned, or in a zone or compartment thereof, which may pose a risk to animal or public health or the environmental status of the Union; (f) the guarantees which the competent authority of the third country or territory concerned can provide regarding compliance or equivalence with the relevant animal health requirements applicable in the Union; (g) the regularity and speed with which the third country or territory concerned supplies information concerning infectious or contagious animal diseases in its territory to the World Organisation for Animal Health (OIE), in particular information concerning the diseases listed in the OIE Codes; (h) the results of controls carried out by the Commission in the third country or territory concerned; (i) any experience gathered from previous entries of animals, germinal products and products of animal origin from the third country or territory concerned and the results of official controls carried out at the point of entry into the Union on such animals, germinal products and products of animal origin. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2). 2. Pending the adoption of the lists provided for in paragraph 1, and provided that such lists have not been drawn up pursuant to the Union legislation referred to in Article 270(2), Member States shall determine from which third countries and territories specific species and categories of animals, germinal products or products of animal origin may enter the Union. For the purposes of the first subparagraph of this paragraph, Member States shall take into account the criteria for inclusion in the lists of third countries and territories provided for in points (a) to (i) of paragraph 1 of this Article. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations from paragraph 2 of this Article, limiting the possibility for Member States to decide from which third countries and territories a specific species and category of animal, germinal product or product of animal origin may enter the Union, where necessary due to the risk posed by that specific species and category of animal, germinal product or product of animal origin.
Article 231 Information to be included in the lists of third countries and territories
The Commission shall specify the following information for each third country or territory in the lists provided for in Article 230(1): (a) the species and categories of animals, germinal products or products of animal origin that may enter the Union from that third country or territory; (b) whether the animals, germinal products or products of animal origin specified in accordance with point (a) may enter the Union from the whole territory of that third country or territory or only from one or more zones or compartments thereof; (c) specific conditions and animal health guarantees concerning listed diseases.
Article 232 Suspension and withdrawal from the lists of third countries and territories and implementing acts
1. The Commission shall, by means of implementing acts, withdraw a country or territory from the lists provided for in Article 230(1), or suspend the entry into the Union of animals, germinal products or products of animal origin from a third country or territory, or from a zone or compartment thereof, for any of the following reasons: (a) the third country or territory concerned, or one or more zones or compartments thereof, no longer complies with the criteria laid down in Article 230(1), where relevant for the entry into the Union of a particular species and category of animal, germinal product or product of animal origin; (b) the animal health situation in the third country or territory concerned, or in a zone or compartment thereof, is such that a suspension or withdrawal from the lists is necessary in order to protect the animal health status of the Union; (c) the Commission has requested the third country or territory concerned to supply up-to–date information on the animal health situation and other matters referred to in Article 230(1), and that third country or territory has not provided such information; (d) the third country or territory concerned has refused to agree to controls being carried out by the Commission on behalf of the Union in its territory. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2). 2. On duly justified imperative grounds of urgency relating to a serious risk of the introduction into the Union of a listed disease as referred to in point (d) of Article 9(1), the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3). 3. The Commission may, by means of implementing acts, reinstate in the lists provided for in Article 230(1) a third country or territory, or a zone or compartment thereof, that has been withdrawn from those lists, or may re–authorise the entry into the Union of animals, germinal products or products of animal origin from a third country or territory, or from a zone or compartment thereof, from which entry into the Union has been suspended, for one of the following reasons: (a) for the reasons referred to in point (a) or (c) of paragraph 1 of this Article, provided that the third country or territory concerned demonstrates that it complies with the listing criteria provided for in Article 230(1); (b) for the reason referred to in point (b) of paragraph 1 of this Article, provided that the third country or territory concerned provides appropriate guarantees that the animal health situation that gave rise to the suspension or withdrawal has been resolved or no longer represents a threat to animal or public health within the Union; (c) for the reason referred to in point (d) of paragraph 1 of this Article, provided that: (i) the third country or territory concerned has agreed to controls being carried out by the Commission on behalf of the Union in its territory; and (ii) the results of those controls by the Commission show that the third country or territory concerned, and the zones or compartments thereof, comply with the listing criteria provided for in Article 230(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 233 Approval and listing of establishments
1. Member States shall only permit the entry into the Union of terrestrial animals and germinal products thereof originating from an establishment of a type for which approval is required in the Union in accordance with Article 94(2) and the rules adopted pursuant to Article 94(3) and Article 95, if the establishment in question in the third country or territory concerned: (a) complies with animal health requirements in that third country or territory which are equivalent to the rules for establishments of that type applicable in the Union; (b) is approved and listed by the competent authority of the third country or territory of dispatch, unless alternative risk-mitigation measures in place in that third country or territory provide equivalent guarantees for animal health within the Union. 2. The Commission shall collect the lists of approved establishments referred to in point (b) of paragraph 1 received from the competent authorities of the third countries or territories concerned. 3. The Commission shall provide to the Member States any new or updated lists of approved establishments received from the third countries or territories concerned, and shall make them publicly available. 4. The Commission shall, by means of implementing acts, adopt any rules necessary in order to ensure uniform application of point (b) of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 234 Animal health requirements for the entry into the Union of species and categories of animals, germinal products and products of animal origin
1. The animal health requirements for the entry into the Union of species and categories of animals, germinal products and products of animal origin from third countries or territories shall: (a) be as stringent as the animal health requirements laid down in this Regulation and in the rules adopted pursuant thereto applicable to movements of the species and categories of animals, germinal products or products of animal origin in question within the Union; or (b) offer equivalent guarantees to the animal health requirements applicable to the species and categories of animals, germinal products or products of animal origin provided for in Part IV (Articles 84 to 228) of this Regulation. 2. The Commission shall adopt delegated acts in accordance with Article 264 concerning the animal health requirements for: (a) the entry into the Union of species and categories of animals, germinal products and products of animal origin from third countries or territories; (b) the movement within the Union and handling of those animals, germinal products and products of animal origin after their entry into the Union, where this is necessary in order to mitigate the risk involved. 3. Pending the adoption of delegated acts laying down animal health requirements as regards a particular species and category of animal, germinal product or product of animal origin provided for in paragraph 1 of this Article, Members State may, following an evaluation of the risks involved, apply national rules, provided that those rules comply with the requirements laid down in that paragraph and provided that they take into account the matters referred to in Articles 235 and 236.
Article 235 Matters to be taken into account in delegated acts provided for in Article 234 with regard to the entry into the Union of animals
The Commission shall take the following matters into account when laying down, in delegated acts as provided for in Article 234(2), animal health requirements for the entry into the Union of particular species and categories of animals: (a) the listed diseases referred to in point (d) of Article 9(1) and emerging diseases; (b) the health status of the Union concerning the listed diseases referred to in point (d) of Article 9(1) and emerging diseases; (c) the listed species with regard to those listed diseases referred to in point (d) of Article 9(1) and emerging diseases; (d) the age and sex of the animals concerned; (e) the origin of the animals concerned; (f) the type of establishment concerned and the type of production at the places of origin and of destination; (g) the intended place of destination; (h) the intended use of the animals concerned; (i) any risk-mitigation measures in place in the third countries or territories of origin or transit, or after the arrival of the animals concerned into the territory of the Union; (j) animal health requirements applicable to movements of those animals within the Union; (k) other epidemiological factors; (l) international animal health trade standards, relevant to the species and categories of those animals.
Article 236 Matters to be taken into account in delegated acts as provided for in Article 234 with regard to the entry into the Union of germinal products and products of animal origin
The Commission shall take the following matters into account when laying down, in delegated acts as provided for in Article 234(2), the animal health requirements for the entry into the Union of germinal products and products of animal origin: (a) the listed diseases referred to in point (d) of Article 9(1) and emerging diseases; (b) the health status of the animals from which the germinal products or products of animal origin originate and of the Union concerning the listed diseases referred to in point (d) of Article 9(1) and emerging diseases; (c) the type and nature of particular germinal products or products of animal origin, treatments, processing methods and other risk-mitigation measures that have been applied at the places of origin, dispatch of consignment or destination; (d) the type of establishment and the type of production at the places of origin and of destination; (e) the intended place of destination; (f) the intended use of the germinal products or products of animal origin concerned; (g) animal health requirements applicable to movements of the germinal products and products of animal origin concerned within the Union; (h) other epidemiological factors; (i) international animal health trade standards, relevant for the germinal products and products of animal origin in question.
Article 237 Animal health certificates, declarations and other documents for entry into the Union
1. Member States shall only permit the entry into the Union of consignments of animals, germinal products and products of animal origin if such consignments are accompanied by one or both of the following: (a) an animal health certificate issued by the competent authority of the third country or territory of origin, unless a derogation is provided for in point (a) of paragraph 4; (b) declarations or other documents, where required by the rules adopted pursuant to point (b) of paragraph 4. 2. Member States shall not permit the entry into the Union of consignments of animals, germinal products and products of animal origin unless the animal health certificate referred to in point (a) of paragraph 1 has been verified and signed by an official veterinarian in a third country or territory in compliance with certification requirements equivalent to those laid down in Article 149(3) or 216(3) and any rules adopted pursuant to Article 149(4) or 216(4). 3. Member States shall permit electronic animal health certificates that are produced, handled and transmitted by means of Traces to replace the accompanying animal health certificates referred to in paragraph 1, where such electronic animal health certificates: (a) contain all the information that the animal health certificate referred to in point (a) of paragraph 1 of this Article is required to contain in accordance with Article 238(1) and any rules adopted pursuant to Article 238(3); (b) ensure the traceability of the consignments of animals, germinal products and products of animal origin concerned and link those consignments to the electronic animal health certificate. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) derogations from the animal health certificate requirements provided for in point (a) of paragraph 1 and paragraph 2 of this Article, for consignments of animals, germinal products and products of animal origin, and in specific rules for the animal health certification of those consignments, where the consignments in question pose an insignificant risk to animal health or public health within the Union, due to one or more of the following factors: (i) the species and categories of animals, germinal products or products of animal origin concerned; (ii) the methods of keeping and types of production of the animals, germinal products and products of animal origin concerned; (iii) their intended use; (iv) alternative risk-mitigation measures which are in place in the third countries or territories of origin or transit, or after their arrival into the territory of the Union, affording equivalent protection of animal health and public health within the Union as provided for in this Regulation; (v) the provision by the third country or territory concerned of guarantees of compliance with the requirements for entry into the Union, demonstrated by means other than an animal health certificate; (b) rules requiring consignments of animals, germinal products and products of animal origin entering into the Union to be accompanied by declarations or other documents needed to demonstrate that the animals, germinal products and products of animal origin in question meet the animal health requirements for entry into the Union laid down in rules adopted pursuant to Article 234(2).
Article 238 Content of animal health certificates
1. The animal health certificate referred to in point (a) of Article 237(1) shall contain at least the following information: (a) the name and address of: (i) the establishment or place of origin; (ii) the establishment or place of destination; (iii) where applicable, establishments for assembly operations or rest of the kept animals concerned; (b) a description of the animals, germinal products or products of animal origin concerned; (c) the number or volume of the animals, germinal products or products of animal origin concerned; (d) where applicable, the identification and registration of the animals, germinal products or products of animal origin concerned; (e) the information needed to demonstrate that the animals, germinal products and products of animal origin concerned fulfil the animal health requirements for entry into the Union provided for in Article 229 and Article 234(1) and in the rules adopted pursuant to Article 234(2) and Article 239. 2. The animal health certificate referred to in point (a) of Article 237(1) may include other information required under other Union legislation. 3. The Commission may, by means of implementing acts, lay down rules concerning: (a) information to be contained in the animal health certificate referred to in point (a) of Article 237(1) in addition to that referred to in paragraph 1 of this Article; (b) information to be contained in declarations or other documents as referred to in point (b) of Article 237(1); (c) model forms for the animal health certificates, declarations and other documents referred to in Article 237(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2). 4. Pending the establishment of rules in implementing acts adopted pursuant to paragraph 3, as regards a particular species and category of animal, germinal product or product of animal origin, Member States may, following an evaluation of the risks involved, apply national rules, provided those national rules comply with the conditions laid down in paragraph 1.
Article 239 Derogations and additional requirements in respect of certain categories of animals, germinal products and products of animal origin
1. For certain specific types of entry of animals, germinal products and products of animal origin, the application of the rules set out in Article 229(1) and Articles 233 and 237 may not be adequate, and special rules may need to be adopted by the Commission through delegated acts which take into account the particular risks, the final destination, the type of final use and other circumstances. 2. The Commission shall adopt delegated acts in accordance with Article 264 concerning the special rules referred to in paragraph 1 of this Article regarding derogations from the requirements provided for in Article 229(1) and Articles 233 and 237 and imposing additional requirements for the entry into the Union of the following: (a) animals: (i) intended for circuses, events, exhibitions, display, shows and confined establishments; (ii) intended to be used for scientific or diagnostic purposes; (iii) for which the Union is not the final destination; (iv) which originate in the Union and which are moved to a third country or territory, and are then moved back to the Union from that third country or territory; (v) which originate in the Union and which are transported through a third country or territory en route to another part of the Union; (vi) which are intended for grazing purposes on a temporary basis, in the vicinity of the Union's borders; (vii) which pose an insignificant risk to the animal health status within the Union; (b) products of animal origin: (i) intended for personal use; (ii) for consumption by the crew and passengers on means of transport arriving from third countries or territories; (c) germinal products and products of animal origin: (i) intended to be used as trade samples; (ii) intended to be used as research and diagnostic samples; (iii) for which the Union is not the final destination; (iv) which originate in the Union and are moved to a third country or territory, and are then moved back to the Union from that third country or territory; (v) which originate in the Union and are transported through a third country or territory en route to another part of the Union; (vi) which pose an insignificant risk to the animal health status within the Union. Those delegated acts shall take into account the matters referred to in Article 235 and 236. 3. The Commission may, by means of implementing acts, lay down rules: (a) concerning model forms for the animal health certificates, declarations and other documents for the categories of animals, germinal products and products of animal origin referred to in paragraph 2 of this Article; (b) indicating, for the products referred to in paragraph 1 of this Article, the codes from the Combined Nomenclature, where such codes are not provided for by other relevant Union rules. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 240 Disease agents and delegated acts
1. Operators, veterinarians, aquatic animal health professionals and animal professionals bringing disease agents into the Union shall: (a) take appropriate measures to ensure that the entry of those disease agents into the Union does not pose a risk to animal health or public health within the Union with regard to listed diseases referred to in point (d) of Article 9(1) and emerging diseases; (b) take appropriate disease control and preventive measures to ensure that the entry of those disease agents into the Union does not present a risk of bioterrorism. This paragraph shall also apply to any other natural or legal person bringing such agents into the Union intentionally. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 laying down requirements for the entry into the Union of disease agents concerning: (a) the packaging of disease agents; (b) other risk-mitigation measures required in order to prevent the release and spread of disease agents.
Article 241 Plant material and delegated and implementing acts
1. The Member States shall take measures to restrict the entry into the Union of consignments of plant material in the event of an unfavourable disease situation in third countries or territories concerning listed diseases as referred to in point (d) of Article 9(1) or emerging diseases, where this is required by the rules adopted in accordance with paragraph 3 of this Article. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the measures referred to in paragraph 1 of this Article, setting out: (a) specific animal health requirements for the entry into the Union of plant material which acts as a path of transmission of listed or emerging diseases; (b) requirements in relation to: (i) animal health certification, taking into account the rules provided for in point (a) of Article 237(1) and Article 237(2) and (3); or (ii) declarations or other documents, taking into account the rules provided for in point (b) of Article 237(1). 3. The Commission shall lay down the animal health requirements provided for in paragraph 2 on the basis of the following criteria: (a) whether a listed or emerging disease that can be transmitted by means of plant material represents a serious risk to animal or to human health in the Union; (b) the likelihood that animals of listed species for a particular listed disease or emerging disease will come into direct or indirect contact with the plant material referred to in paragraph 2; (c) the availability and effectiveness of alternative risk-mitigation measures in relation to that plant material, which may eliminate or minimise the risk of transmission referred to in point (a). 4. The Commission may, by means of implementing acts, lay down rules indicating, for the plant material referred to in paragraph 2 of this Article, the codes from the Combined Nomenclature, where such indication is not provided for by other relevant Union rules. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 242 Means of transport, equipment, packaging materials, transport water and feed and fodder and delegated and implementing acts
1. Operators bringing animals and products into the Union shall take the appropriate and necessary disease prevention measures during transport, as provided for in Articles 125(1) and 192(1). 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) specific animal health requirements for the entry into the Union of: (i) means of transport for animals and products; (ii) equipment, packaging material or transport water for animals and products, or feed and fodder which may transmit animal diseases; (b) requirements in relation to: (i) animal health certification, taking into account the rules provided for in point (a) of Article 237(1) and Article 237(2) and (3); or (ii) declarations or other documents, taking into account the rules provided for in point (b) of Article 237(1). 3. The Commission shall lay down the animal health requirements provided for in paragraph 2 of this Article in the event of a unfavourable disease situation concerning one or more listed diseases as referred to in point (d) of Article 9(1), or emerging diseases, which present a serious risk to animal and human health in the Union, in: (a) a neighbouring third country or territory; (b) the third country or territory of origin; (c) a third country or territory of transit. 4. The Commission may, by means of implementing acts, lay down rules indicating, for the goods referred to in point (a) of paragraph 2 of this Article, the codes from the Combined Nomenclature, where such indication is not provided for by other relevant Union rules. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 243 Export from the Union
1. Member States shall take the appropriate measures to ensure that the export and re–export from the Union to a third country or territory of animals and products takes place in accordance with the rules for the movement of animals and products between Member States provided for in Part IV (Articles 84 to 228), while taking into account the animal health status within the third country or territory of destination, or the relevant zone or compartment thereof, with regard to the listed diseases referred to in point (d) of Article 9(1) and emerging diseases. 2. By way of derogation from paragraph 1, if so requested by the competent authority of a third country or territory importing the animals and products in question, or if established by the legal and administrative procedures in force in that third country or territory, export and re–export from the Union may take place in accordance with the provisions in force in that third country or territory, provided that such exports or re-exports do not jeopardise public or animal health. 3. Where the provisions of a bilateral agreement concluded between the Union and a third country or territory are applicable, animals and products exported from the Union to that third country or territory shall comply with those provisions.
Article 244 Scope of Part VI
1. This Part shall apply to the non–commercial movement of pet animals into a Member State from another Member State or from a third country or territory. 2. It shall apply without prejudice to: (a) Council Regulation (EC) No 338/97 ( 63 ) ; (b) any national measures adopted, published and made available to the public by Member States to restrict the movement of certain species or breeds of pet animals on the basis of considerations other than those relating to animal health.
Article 245 General provisions
1. Non–commercial movements of pet animals that fulfil the animal health requirements laid down in this Part shall not be prohibited, restricted or impeded on animal health grounds other than those resulting from the application of this Part. 2. Where the non–commercial movement of a pet animal is carried out by an authorised person, it may only take place within five days from the movement of the pet owner. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning requirements supplementing the rules laid down in paragraph 2 of this Article in relation to the following: (a) documentation of the non–commercial movement of a pet animal carried out by an authorised person; (b) granting of derogations from the period referred to in paragraph 2 of this Article. 4. The Commission may, by means of implementing acts, lay down requirements for the layout, languages and validity of the declaration authorising an authorised person in writing to carry out the non–commercial movement of a pet animal on behalf of the pet owner. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 246 Maximum number of pet animals
1. The number of pet animals of the species listed in Part A of Annex I which may be moved during a single non–commercial movement shall not exceed five. 2. By way of derogation from paragraph 1, the number of pet animals of the species listed in part A of Annex I may exceed five if the following conditions are fulfilled: (a) the non–commercial movement in question is for the purpose of participating in a competition, exhibition or sporting event or training for such an event; (b) the pet owner or the authorised person concerned submits written evidence that the pet animals are registered either to attend an event as referred to in point (a), or with an association organising such events; (c) the pet animals are more than six months old. 3. In order to prevent commercial movements of pet animals of the species listed in Part B of Annex I from being fraudulently disguised as non–commercial movements, the Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules setting the maximum number of pet animals of those species which may be moved during a single non–commercial movement.
Article 247 Conditions applicable to non–commercial movements of pet animals of the species listed in Part A of Annex I
Pet animals of the species listed in Part A of Annex I shall not be moved into a Member State from another Member State unless: (a) they are individually identified by a physical means of identification in accordance with the rules adopted pursuant to point (a) of Article 252(1); (b) they fulfil the relevant prevention and risk-mitigation measures adopted pursuant to point (b) of Article 252(1) in relation to listed diseases as referred to in point (d) of Article 9(1); (c) they are accompanied by an identification document duly completed and issued in accordance with the rules adopted pursuant to point (d) of Article 254.
Article 248 Conditions applicable to non–commercial movements of pet animals of the species listed in Part B of Annex I
1. In so far as the Commission has adopted a delegated act pursuant to point (b) of Article 252(1) with regard to pet animals of one of the species listed in Part B of Annex I, non-commercial movements of pet animals of that species into a Member State from another Member State shall be subject to compliance with the conditions laid down in paragraph 2 of this Article. 2. Pet animals of the species referred to in paragraph 1 may be moved into a Member State from another Member State only if: (a) they are identified or described, either individually or in groups, in accordance with the rules adopted pursuant to point (a) of Article 252(1); (b) they comply with the relevant prevention and risk-mitigation measures adopted pursuant to point (b) of Article 252(1) in relation to listed diseases as referred to in point (d) of Article 9(1); (c) they are accompanied by an identification document duly completed and issued in accordance with the rules adopted pursuant to point (d) of Article 254; 3. Pending the adoption of the relevant delegated acts referred to in paragraph 1, Member States may apply national rules to non–commercial movements of pet animals of the species listed in Part B of Annex I into their territory from another Member State, provided that such rules are: (a) applied proportionately to the risk to public or animal health associated with non–commercial movements of pet animals of those species; and (b) not stricter than those applied to movements of animals of those species in accordance with Part IV.
Article 249 Conditions applicable to non–commercial movements of pet animals of the species listed in Part A of Annex I
1. Pet animals of the species listed in Part A of Annex I shall not be moved into a Member State from a third country or territory unless: (a) they are individually identified by a physical means of identification in accordance with the rules adopted pursuant to point (a) of Article 252(1); (b) they comply with the relevant prevention and risk-mitigation measures adopted pursuant to point (b) of Article 252(1) in respect of listed diseases as referred to in point (d) of Article 9(1); (c) they are accompanied by an identification document duly completed and issued in accordance with the rules adopted pursuant to point (d) of Article 254. 2. Pet animals of the species listed in Part A of Annex I may be moved into a Member State from a third country or territory other than those listed pursuant to Article 253(1)(d) only through a point of entry listed for that purpose. Each Member State shall draw up a list of those points of entry within its territory and shall make that list available to the public. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the conditions for granting derogations from paragraph 2 of this Article.
Article 250 Conditions applicable to non–commercial movements of pet animals of the species listed in Part B of Annex I
1. In so far as the Commission has adopted a delegated act pursuant to point (b) of Article 252(1) with regard to pet animals of one of the species listed in Part B of Annex I, non–commercial movements of pet animals of that species into a Member State from a third country or territory shall be subject to compliance with the conditions laid down in paragraph 2 of this Article. 2. Pet animals of the species referred to in paragraph 1 may be moved into a Member State from a third country or territory only if: (a) they are identified or described, either individually or in groups, in accordance with the rules adopted pursuant to point (a) of Article 252(1); (b) they comply with the relevant prevention and risk-mitigation measures adopted pursuant to point (b) of Article 252(1) in relation to listed diseases as referred to in point (d) of Article 9(1); (c) they are accompanied by an identification document duly completed and issued in accordance with the rules adopted pursuant to point (d) of Article 254; (d) when coming from a third country or territory other than those listed pursuant to point (d) of Article 253(1), they enter through a point of entry listed for that purpose. Each Member State shall draw up a list of those points of entry within its territory and shall make that list available to the public. 3. Pending the adoption of the relevant delegated acts referred to in paragraph 1, Member States may apply national rules to non–commercial movements of pet animals of the species listed in Part B of Annex I into their territory from a third country or territory, provided that such rules are: (a) applied proportionately to the risk to public or animal health associated with non–commercial movements of pet animals of those species; and (b) not stricter than those applied to the entry into the Union of animals of those species in accordance with Part V.
Article 251 Derogation from the conditions applicable to non–commercial movements of pet animals between certain countries and territories
By way of derogation from Articles 249 and 250, non–commercial movements of pet animals between the following countries and territories may continue under the conditions laid down by the national rules of those countries and territories: (a) San Marino and Italy; (b) the Vatican and Italy; (c) Monaco and France; (d) Andorra and France; (e) Andorra and Spain; (f) Norway and Sweden; (g) the Faeroe Islands and Denmark; (h) Greenland and Denmark.
Article 252 Delegation of powers concerning the identification of pet animals and prevention and risk-mitigation measures
1. The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) detailed species–specific requirements for: (i) the means of identification of pet animals of the species listed in Annex I provided for in point (a) of Article 247, point (a) of Article 248(2), point (a) of Article 249(1) and point (a) of Article 250(2); (ii) the application and use of those means of identification; (b) detailed species–specific requirements for the prevention and risk-mitigation measures to ensure that pet animals do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) due to movements of pet animals of the species listed in Annex I as provided for in point (b) of Article 247, point (b) of Article 248(2), point (b) of Article 249(1) and point (b) of Article 250(2). 2. Where, in the case of emerging risks, imperative grounds of urgency so require, the procedure provided for in Article 265 shall apply to rules adopted pursuant to point (b) of paragraph 1 of this Article. 3. The species–specific prevention and risk-mitigation measures authorised by a delegated act adopted pursuant to point (b) of paragraph 1 of this Article shall be based on adequate, reliable and validated scientific information and applied proportionately to the risk to public or animal health associated with non–commercial movements of pet animals likely to be affected by listed diseases as referred to in point (d) of Article 9(1). 4. The delegated acts provided for in point (b) of paragraph 1 may also comprise the following: (a) rules for the categorisation of Member States or parts thereof according to their animal health status and their surveillance and reporting systems with regard to certain diseases that are likely to be spread by movements of pet animals of the species listed in Annex I; (b) the conditions that Member States are to fulfil in order to remain eligible for the application of the prevention and risk-mitigation measures referred to in point (b) of paragraph 1; (c) the conditions for applying and documenting the prevention and risk-mitigation measures referred to in point (b) of paragraph 1; (d) the criteria for granting and, where appropriate, documenting derogations in certain specified circumstances from the application of the prevention and risk-mitigation measures referred to in point (b) of paragraph 1; (e) the criteria for granting and documenting derogations in certain specified circumstances from the conditions referred to in Articles 247 to 250.
Article 253 Implementing acts concerning prevention and risk-mitigation measures
1. The Commission shall, by means of implementing acts, as regards pet animals of the species listed in Part A of Annex I: (a) lay down rules on the format, layout and languages of any documents required under points (c) and (d) of Article 252(4); (b) adopt a list of Member States that comply with the conditions referred to in point (d) of Article 252(4) and remove Member States from that list should any change occur in relation to those conditions; (c) adopt a list of Member States that comply with the rules for categorisation of Member States or parts thereof referred to in point (a) of Article 252(4) and remove Member States from that list should any change occur in relation to those rules; (d) adopt a list of third countries and territories that comply with the conditions referred to in point (d) of Article 252(4) and remove third countries or territories from that list should any change occur in relation to those conditions. 2. The Commission may, by means of implementing acts, as regards pet animals of the species listed in Part B of Annex I, adopt a list of third countries and territories that comply with the conditions referred to in point (d) of Article 252(4) and remove third countries or territories from that list should any change occur in relation to those conditions. 3. The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2). 4. On duly justified imperative grounds of urgency relating to serious risks, the Commission shall adopt immediately applicable implementing acts updating the lists referred to in points (b) and (d) of paragraph 1 of this Article in accordance with the procedure referred to in Article 266(3).
Article 254 Delegation of powers concerning identification documents
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning: (a) entries for the insertion of the information to be included in the identification documents referred to in point (c) of Article 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2); (b) the distribution of blank identification documents as referred to in point (c) of Article 247; (c) the conditions for granting derogations in relation to the format of the identification documents provided for in point (c) of Article 247 and point (c) of Article 249(1); (d) the issue, completion and, where applicable, endorsement of the identification documents provided for in point (c) of Articles 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2).
Article 255 Implementing acts concerning identification documents
1. The Commission shall adopt implementing acts laying down the model for identification documents as referred to in point (c) of Article 247 and point (c) of Article 249(1). That model shall contain the respective entries referred to in point (a) of Article 254, as well as requirements concerning the languages, layout, validity or security features of those identification documents. 2. The Commission may, by means of implementing acts, adopt: (a) the model for identification documents as referred to in point (c) of Article 248(2) and point (c) of Article 250(2), which are to contain the respective entries referred to in point (a) of Article 254, as well as requirements concerning the languages, layout, validity or security features of those identification documents; (b) the rules necessary for transition to the model identification document referred to in point (c) of Article 247. 3. The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 256 Information obligations
1. Member States shall provide the public with clear and easily accessible information concerning the animal health requirements applicable to non–commercial movements of pet animals, including: (a) conditions for the grant of certain derogations referred to in point (d) of Article 252(4); (b) conditions for the grant of derogations referred to in point (e) of Article 252(4); (c) requirements for the application of the means of identification referred to in point (a)(ii) of Article 252(1); (d) conditions applicable to non–commercial movements into Member States' territories of pet animals of the species referred to in Part B of Annex I, which are laid down by their national rules as provided for in Articles 248(3) and 250(3); (e) conditions applicable to non–commercial movements into Member States' territories of pet animals from certain countries and territories laid down by their national rules as referred to in Article 251; (f) any relevant information concerning certain prevention and risk-mitigation measures as referred to in point (b) of Article 252(1). 2. Member States shall establish internet–based information pages providing the information referred to in paragraph 1, and shall communicate the internet address of those pages to the Commission. 3. The Commission shall assist the Member States in making that information available to the public by providing on its internet page: (a) links to the internet–based information pages of the Member States; (b) the information referred to in points (a) and (d) of paragraph 1, and the information made available to the public as referred to in point (b) of Article 244(2) in additional languages, as appropriate.
Article 257 Emergency measures to be taken by the competent authority of the Member State in the territory of which an outbreak of a listed disease or emerging disease, or a hazard occurred
1. In the event of an outbreak of a listed disease or emerging disease, or the occurrence of a hazard which is likely to constitute a serious risk to animal or public health, the competent authority of the Member State where it occurred shall, depending on the gravity of the situation and the disease or hazard in question, immediately take one or more of the following emergency measures to prevent the spread of the disease or hazard: (a) for listed diseases: (i) referred to in point (a) of Article 9(1), the disease control measures laid down in Chapter 1 of Title II of Part III (Articles 53 to 71); (ii) referred to in point (b) of Article 9(1), the disease control measures laid down in Articles 72 to 75 and 77 to 81 of Chapter 2 of Title II of Part III; (iii) referred to in point (c) of Article 9(1), the disease control measures laid down in Articles 76 to 78 and Articles 80 and 82 of Chapter 2 of Title II of Part III; (b) for emerging diseases and hazards: (i) restrictions on the movement of animals and products originating from the establishments, or, where relevant, the restricted zones or compartments, where the outbreak or the hazard occurred, and on means of transport and other material that may have come into contact with those animals or products; (ii) quarantine of animals and isolation of products; (iii) surveillance and traceability measures; (iv) any emergency disease control measures provided for in Chapter 1 of Title II of Part III (Articles 53 to 71) that are appropriate; (c) any other emergency measure which it deems appropriate in order to effectively and efficiently control and prevent the spread of the disease or hazard. 2. The competent authority referred to in paragraph 1 shall inform the Commission and the other Member States: (a) immediately of any outbreak or the occurrence of a hazard as referred to in paragraph 1; (b) without delay of the emergency measures taken pursuant to paragraph 1.
Article 258 Emergency measures to be taken by a Member State other than the Member State where the outbreak or hazard occurred
1. The competent authority of a Member State other than the Member State where the outbreak or hazard referred to in Article 257(1) occurred shall, depending on the gravity of the situation and the disease or hazard in question, take one or more of the emergency measures referred to in Article 257(1) where it detects on its territory animals or products from the Member State referred to in Article 257(1) or means of transport or any other material that may have come into contact with such animals and products. 2. The competent authority referred to in paragraph 1 of this Article may, where a serious risk exists pending the adoption of emergency measures by the Commission in accordance with Article 259, take the emergency measures referred to in Article 257(1) on an interim basis, depending on the gravity of the situation with regard to animals or products originating from the establishments or other locations, or where relevant from the restricted zones of the Member State, where the disease or hazard referred to in Article 257(1) occurred, or means of transport or other material that may have come into contact with such animals. 3. A Member State may take measures as referred to in Article 257(1) in the event of an outbreak in a third country or territory bordering the Union of a disease referred to in point (a) of Article 9(1) or an emerging disease in such a third country or territory, in so far as those measures are necessary in order to prevent the spread of the disease into the territory of the Union. 4. The competent authority referred to in paragraph 1 and the competent authority of the Member State referred to in paragraph 3 shall inform the Commission and other Member States: (a) immediately of the outbreak or occurrence of a hazard referred to in paragraph 1; (b) without delay of the emergency measures taken pursuant to paragraphs 1 and 2.
Article 259 Commission emergency measures
1. In the event of an outbreak or the occurrence of a hazard as referred to in Article 257(1), and of emergency measures taken by the competent authorities of the Member States in accordance with Article 257(1) and Article 258(1), (2) and (3), the Commission shall review the situation and the emergency measures taken, and shall adopt, by means of an implementing act, one or more of the emergency measures provided for in Article 257(1) concerning the animals and products in question and means of transport and other material that may have come into contact with those animals or products, in any of the following cases: (a) where the Commission has not been informed of any measures taken pursuant to Article 257(1) and Article 258(1), (2) and (3); (b) where the Commission considers the measures taken pursuant to Article 257(1) and Article 258(1), (2) and (3) to be inadequate; (c) where the Commission considers it necessary to approve or replace the measures taken by the competent authorities of the Member States pursuant to Article 257(1) and Article 258(1), (2) and (3) in order to avoid unjustified disruptions in the movement of animals and products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2). 2. On duly justified imperative grounds of urgency relating to serious risks of the spread of a disease or a hazard, the Commission may adopt immediately applicable implementing acts in accordance with Article 266(3).
Article 260 Emergency measures to be taken by the competent authority
Where the competent authority of a Member State becomes aware of animals or products originating from a third country or territory, or of means of transport or materials, which may have come into contact with such animals and products, that are likely to constitute a serious risk in the Union due to possible infection or contamination by listed diseases or emerging diseases or hazards, it shall: (a) immediately take one or more of the following emergency measures necessary to mitigate that risk, depending on the gravity of the situation: (i) destruction of the animals and products concerned; (ii) quarantine of animals and isolation of products; (iii) surveillance and traceability measures; (iv) any disease control measures referred to in Chapter 1 of Title II of Part III (Articles 53 to 71), where appropriate; (v) any other emergency measure which it deems appropriate to prevent the spread of the disease or hazard into the Union; (b) immediately inform the Commission and the other Member States of the risks associated with the animals and products in question and of the origin of those animals and products by means of Traces, and without delay of the emergency measures taken pursuant to point (a).