(a)

were produced in accordance with these requirements, in particular that the vessel appears on the list of vessels from which imports to the Union are permitted (being ‘EU-listed’):

(b)

the vessel applies general hygiene requirements, implements 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 is listed as a Union approved establishment;

(c)

the fishery products or fishery products derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods have been caught and handled on board vessels, landed, handled and, where appropriate, prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in Section VIII, Chapters I to IV, of Annex III, to Regulation (EC) No 853/2004. Viscera and parts that may pose a danger to public health have been removed as quickly as possible and kept apart from products intended for human consumption;

(d)

the fishery products or fishery products derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods satisfy the health standards laid down in Section VIII, Chapter V, of Annex III, to Regulation (EC) No 853/2004 [satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004] (delete as appropriate) and, where appropriate, the criteria laid down in Commission Regulation (EC) No 2073/2005 (5);

(e)

the fishery products or fishery products derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods have been packaged, stored and transported in compliance with Section VIII, Chapters VI to VIII, of Annex III to Regulation (EC) No 853/2004;

(f)

the fishery products or fishery products derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods have been marked in accordance with Section I of Annex II to Regulation (EC) No 853/2004;

(g)

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;

(h)

the fishery products 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/EC (6), and the concerned animals and products are listed in Commission Decision 2011/163/EU (7) for the concerned country of origin;

(i)

the fishery products or fishery products derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods have been produced under conditions guaranteeing compliance with the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006 (8); and

(j)

frozen fishery products or fishery products derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods have been kept at a temperature of not more than -18°C in all parts of the product. Whole fish initially frozen in brine intended for the production of canned food may be kept at a temperature of not more than -9°C.

(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) 2021/405 (14);

(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 2073/2005 (15);

(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) 2019/627 (16) 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) 2019/624 (17)] (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/EC (18), and the concerned animals and products are listed in Commission Decision 2011/163/EU (19) 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 Council (20), and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006 (21).

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:

(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:

(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) 2021/404 (23) 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.

(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).]

—

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).]

(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.2.6.1.

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: