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Commission Implementing Regulation (EU) 2022/2504 of 19 December 2022 amending Annexes III and V to Implementing Regulation (EU) 2020/2235 as regards model animal health/official certificates and official certificates for the entry into the Union of consignments of certain fishery products and highly refined products of animal origin, and model private attestation for entering certain composite products into the Union (Text with EEA relevance)

Type Implementing Regulation

Publication 2022-12-20

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

articles 3

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API

COUNTRY COUNTRY COUNTRY Certificate model MOL-HC Certificate model MOL-HC Certificate model MOL-HC Certificate model MOL-HC

II. Health information II. Health information II.a Certificate reference II.b IMSOC reference

Part II: Certification II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted.

[Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11) [Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11) [Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11) [Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11) [Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11) [Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11)

Name (in capital letters)

Date Qualification and title Qualification and title

Stamp Signature Signature

COUNTRY	COUNTRY	COUNTRY	Certificate model MOL-HC	Certificate model MOL-HC	Certificate model MOL-HC	Certificate model MOL-HC
	II. Health information	II. Health information	II.a	Certificate reference	II.b	IMSOC reference
Part II: Certification	II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted.	II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted.	II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted.	II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted.	II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted.	II.1. ⁽¹⁾Public health attestation [To be deleted when the Union is not the final destination of the live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from these animals] I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council²⁰, Regulation (EC) No 852/2004 of the European Parliament and of the Council²¹, Regulation (EC) No 853/2004 of the European Parliament and of the Council²² and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation)²³ and hereby certify that the ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods] described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in a region/regions or a country/countries which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of ⁽⁴⁾[live bivalve molluscs] ⁽⁴⁾[live echinoderms] ⁽⁴⁾[live tunicates] ⁽⁴⁾[live marine gastropods] ⁽⁴⁾)[products of animal origin derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods], and listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405²⁴; (b) come from (an) establishment(s) applying general hygiene requirements and implementing a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, regularly audited by the competent authorities, and being listed as a Union approved establishment; (c) have been harvested, where necessary relayed and transported in accordance with Section VII, Chapters I and II, of Annex III to Regulation (EC) No 853/2004; (d) ⁽⁴⁾[were handled, where necessary purified, and packaged in compliance with Section VII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) ⁽⁴⁾[were prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004]]; (f) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, ⁽⁴⁾[Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] and the criteria laid down in Commission Regulation (EC) No 2073/2005²⁵; (g) have been packaged, stored and transported in compliance with ⁽⁴⁾[Section VII, Chapters VI and VIII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section VIII, Chapters VI, VII and VIII, of Annex III to Regulation (EC) No 853/2004]; (h) have been marked and labelled in accordance with ⁽⁴⁾[Section I of Annex II and Section VII, Chapter VII, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾[Section I of Annex II to Regulation (EC) No 853/2004]; (i) in the case of Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, these comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (j) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627²⁶ as [A] [B] or [C] at the moment of their harvesting (please indicate the classification of the production area at the moment of harvesting) (except for Pectinidae, marine gastropods and echinoderms that are not filter feeders, which are harvested outside classified production areas); (k) have satisfactorily undergone the official controls laid down in ⁽⁴⁾[Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624²⁷] ⁽⁴⁾[Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627]; (l) fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC²⁸, and the concerned animals and products are listed in Commission Decision 2011/163/EU²⁹ for the concerned country of origin; (m) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council³⁰, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006³¹. ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of ⁽³⁾ listed species intended for human consumption and products of animal origin from those molluscs which are intended for further processing in the Union before human consumption, excluding wild molluscs and their products landed from fishing vessels I, the undersigned official veterinarian, hereby certify that: II.2.1. According to official information, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following animal health requirements: II.2.1.1. they originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] which is not subject to national restriction measures for animal health reasons or because of the occurrence of abnormal mortalities with an undetermined cause, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692³² and emerging diseases; II.2.1.2. the ⁽⁴⁾[aquatic animals are not intended to be killed] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals, have been obtained from animals which were not intended to be killed] under a national programme for the eradication of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases. ⁽⁴⁾[II.2.2. The ⁽⁴⁾[aquaculture animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquaculture animals other than live aquaculture animals referred to in Box I.27 of Part I, have been obtained from animals which] meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is ⁽⁴⁾[registered] ⁽⁴⁾[approved] by, and under the control of, the competent authority of the third country or territory of origin and which has a system in place to maintain and to keep for a period of at least 3 years, up-to-date records containing information regarding: (i) the species, categories and number of aquaculture animals on the establishment; (ii) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (iii) the mortality in the establishment; II.2.2.2. they come from an aquaculture establishment which receives regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and of emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I have been obtained from animals which] meet the following animal health requirements: ⁽⁴⁾⁽⁶⁾[II.2.3.1. they are subject to the requirements referred to in Part II.2.4, and originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] with ⁽⁵⁾code: __ __ - __ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXI to Commission Implementing Regulation (EU) 2021/404³³ for the entry into the Union of those ⁽⁴⁾[aquatic animals] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals];] ⁽⁴⁾⁽⁶⁾[II.2.3.2. they are aquatic animals that have undergone clinical inspection by an official veterinarian within a period of 72 hours prior to the time of loading for dispatch to the Union. During the inspection, the animals showed no clinical symptoms of transmissible disease and, according to the relevant records of the establishment, there was no indication of disease problems;] II.2.3.3. they are aquatic animals which are dispatched directly from the place of origin to the Union; II.2.3.4. they have not been in contact with aquatic animals of a lower health status. either ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for ⁽³⁾listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] declared free from ⁽⁴⁾[Infection with Mikrocytos mackini] ⁽⁴⁾[Infection with Perkinsus marinus] in accordance with conditions which are at least as stringent as those laid down in Article 66 or in Article 73(1) and Article 73(2), point (a), of Commission Delegated Regulation (EU) 2020/689³⁴ and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: (i) introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); (ii) not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁷⁾ [II.2.4.2. Requirements for ⁽³⁾listed species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone,] ⁽⁴⁾[ compartment] declared free from ⁽⁴⁾[infection with Marteilia refringens] ⁽⁴⁾[infection with Bonamia exitiosa] ⁽⁴⁾[ infection with Bonamia ostreae] in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 and in the case of aquatic animals, all ⁽³⁾listed species for the relevant disease(s) are: — introduced from another country, territory, zone or compartment which has been declared free from the same disease(s); — not vaccinated against ⁽⁴⁾[that] ⁽⁴⁾[those] disease(s).] ⁽⁴⁾⁽⁸⁾ [II.2.4.3. Requirements for ⁽⁹⁾species susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which fulfils the health guarantees as regards OsHV-1 μvar which are necessary to comply with the national measures which apply in the Member State of destination in accordance with Article 175 of Delegated Regulation (EU) 2020/692, and for which the Member State or part thereof, is listed in ⁽⁴⁾[Annex I] ⁽⁴⁾[Annex II] to Commission Implementing Decision (EU) 2021/260³⁵.]] or ⁽⁴⁾⁽⁶⁾ [II.2.4. Specific health requirements The ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] are destined for a disease control aquatic food establishment within the Union which is approved in accordance with Article 11 of Commission Delegated Regulation (EU) 2020/691³⁶, where they are to be processed for human consumption.] II.2.5. To the best of my knowledge, and as declared by the operator, the ⁽⁴⁾[aquatic animals referred to in Box I.27 of Part I] ⁽⁴⁾[products of animal origin from aquatic animals other than live aquatic animals referred to in Box I.27 of Part I, have been obtained from animals which] originate from ⁽⁴⁾[an establishment] ⁽⁴⁾[a habitat] where: (i) there were no abnormal mortalities with an undetermined cause; and (ii) the animals have not been in contact with aquatic animals of ⁽³⁾listed species which did not comply with the requirements referred to in point II.2.1. II.2.6. Transport requirements Arrangements have been made to transport the aquatic animals referred to in Box I.27 of Part I in accordance with the requirements laid down in Articles 167 and 168 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.6.1. when the animals are transported in water, the water is not changed in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union; II.2.6.2. the animals are not transported under conditions that jeopardise their health status, in particular: (i) when the animals are transported in water, it does not alter their health status; (ii) the means of transport and the containers are constructed in such a way that the health status of the aquatic animals is not jeopardised during transportation; (iii) the ⁽⁴⁾[container] ⁽⁴⁾[well-boat] is ⁽⁴⁾[previously unused] ⁽⁴⁾[cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] of origin, prior to loading for dispatch to the Union]; II.2.6.3. from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or ⁽⁴⁾[container] ⁽⁴⁾[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union; II.2.6.4. where a water exchange is necessary in a ⁽⁴⁾[country] ⁽⁴⁾[territory] ⁽⁴⁾[zone] ⁽⁴⁾[compartment] which is listed for entry of the particular species and category of aquatic animals into the Union, it only occurs ⁽⁴⁾[in the case of transport on land, at water exchange points approved by the competent authority of the ⁽⁴⁾[third country] ⁽⁴⁾[territory] where the water exchange takes place] ⁽⁴⁾[in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union]. II.2.7. Labelling requirements Arrangements have been made to identify and label the ⁽⁴⁾[means of transport] ⁽⁴⁾[containers] in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by ⁽⁴⁾[a legible and visible label on the exterior of the container] ⁽⁴⁾[an entry in the ships manifest when transported by well-boat], which clearly links the consignment to this animal health/official certificate; ⁽⁴⁾[II.2.7.2. in the case of live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains: (a) details of the number of containers in the consignment; (b) the name of the species present in each container; (c) details of the number of animals in each container for each of the species present; (d) the following statement: ‘live molluscs intended for human consumption in the European Union’;] ⁽⁴⁾[II.2.7.3. in the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1 contains at least the following statement: ‘molluscs intended for human consumption after further processing in the European Union’.] ^{(4) (10)} II.2.8. Validity of animal health/official certificate This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for entry into the Union of live bi-valve molluscs and products of animal origin from those animals intended for human consumption, including when the Union is not the final destination of such bivalve molluscs and their products. ‘Aquatic animals’ are animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 of the European Parliament and of the Council³⁷‘Aquaculture animals’ are aquatic animals which are subject to aquaculture as defined in Article 4, point (7), of Regulation (EU) 2016/429. ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread. All aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, to which Part II.2.4. of this animal health/official certificate applies, must originate from a country/territory/zone/compartment which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Part II.2.4. of the animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a country or region thereof which is listed in Annex VIII to Implementing Regulation (EU) 2021/405: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment; (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004; (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. This animal health/official certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8: Region of origin: indicate the production area and its classification at the time of harvest, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 shall not apply to countries with special public health certification requirements laid down in equivalence agreements or other Union legislation. ⁽²⁾ Part II.2. of this animal health/official certificate shall not apply and must be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882³⁸; or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union. ⁽³⁾ Species listed in columns 3 and 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882. Species listed in column 4 shall only be regarded as vectors under the conditions set out in Article 171 of Delegated Regulation (EU) 2020/692. ⁽⁴⁾ Keep if appropriate/delete if not applicable. In the case of Part II.2.4.1, deletion is not permitted if the consignment contains listed species for infection with Mikrocytos mackini or infection with Perkinsus marinus, other than in the circumstances referred to in footnote (6). ⁽⁵⁾ Code of the third country/territory/zone/compartment as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Parts II.2.3.1, II.2.3.2. and II.2.4 shall not apply and must be deleted if the consignment contains only the following aquatic animals: (a) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment, (b) molluscs which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packages laid down in Regulation (EC) No 853/2004, (c) molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals laid down in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing. ⁽⁷⁾ Applicable only when the Member State/zone/compartment of destination in the Union either has disease-free status for a category C disease as defined in Article 1, point (3), of Implementing Regulation (EU) 2018/1882, or is subject to an optional eradication programme established in accordance with Article 31(2) of Regulation (EU) 2016/429, otherwise delete. ⁽⁸⁾ Applicable when the Member State of destination in the Union or part thereof, has approved national measures for a specific disease as listed in Annex I or Annex II to Implementing Decision (EU) 2021/260, otherwise delete. ⁽⁹⁾ Susceptible species as referred to in the second column of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹⁰⁾ Shall apply only to the consignments of live aquatic animals. ⁽¹¹⁾ to be signed by: — an official veterinarian when Part II.2 Animal health attestation is not deleted, — a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted.
	[Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11)	[Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11)	[Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11)	[Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11)	[Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11)	[Official veterinarian] ^(4)(11)/ [Certifying officer]^(4)(11)
	Name (in capital letters)
	Date		Qualification and title	Qualification and title
	Stamp		Signature	Signature

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