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Document 32022R2504

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)

C/2022/9350

OJ L 325, 20.12.2022, p. 62–86 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

In force

ELI: http://data.europa.eu/eli/reg_impl/2022/2504/oj

20.12.2022   

EN

Official Journal of the European Union

L 325/62


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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 on laying specific hygiene rules for food of animal origin (1), and in particular Article 7(2), point (a), thereof,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (2), and in particular Articles 238(3) and 239(3) thereof,

Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (3), and in particular Article 90, first paragraph , points (a) and (b), and Article 126(3) thereof,

Whereas:

(1)

Commission Implementing Regulation (EU) 2020/2235 (4) lays down rules regarding, inter alia, official certificates provided for in Regulation (EU) 2017/625 required for the entry into the Union of certain consignments of products of animals origin. In particular, Annex III to Implementing Regulation (EU) 2020/2235 lays down, inter alia, 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.

(2)

Chapters 30 and 31 of Annex III to Implementing Regulation (EU) 2020/2235 set out, respectively, the model official certificate for the entry into the Union of fishery products or fishery products derived from bivalve molluscs intended for human consumption entering the Union directly from a reefer, freezer or factory vessel flying the flag of a third country as provided for in Article 11(3) of Commission Delegated Regulation (EU) 2019/625 (5) (model FISH/MOL-CAP) and the model animal health/official certificate for the entry into the Union of live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from those animals intended for human consumption (model MOL-HC). Commission Delegated Regulation (EU) 2022/2258 (6) amended Article 11 of Delegated Regulation (EU) 2019/624 (7), whereby the classification of production and relaying areas is not required in relation to the harvesting of echinoderms which are not filter feeders. The model official certificate and the model animal health/official certificate for the entry into the Union of such fishery products should therefore be amended accordingly.

(3)

Chapter 46 of Annex III to Implementing Regulation (EU) 2020/2235 sets out the model official certificate for the entry into the Union of highly refined chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids intended for human consumption (model HRP). Delegated Regulation (EU) 2022/2258 amended Regulation (EC) No 853/2004, adding fat derivatives and food flavourings that are authorised in accordance with Regulation (EC) No 1334/2008 of the European Parliament and of the Council (8), subject to treatments excluding any public or animal health risk, as highly refined products. The model official certificate for the entry into the Union of such highly refined products should be amended accordingly.

(4)

Annex III to Implementing Regulation (EU) 2020/2235 should therefore be amended accordingly.

(5)

The model private attestation set out in Annex V to Implementing Regulation (EU) 2020/2235 for operators entering shelf-stable composite products into the Union should also be updated to facilitate filling out of the document, reflecting the experience gained, adding explanations and notes in order to facilitate provision of the information by importing food business operators. Gelatine, collagen and certain highly refined products can be imported without submitting a residue monitoring plan and, consequently, it should not be necessary that countries are listed in the Annex to Commission Decision 2011/163/EU (9) to be allowed to export these products to the Union or to use these products as ingredients in composite products for export to the Union, although listing in accordance with Articles 18, 19 or 22 of Commission Implementing Regulation (EU) 2021/405 (10) remains mandatory. Therefore, the private attestation set out in Annex V to Implementing Regulation (EU) 2020/2235 should be replaced by an updated version.

(6)

Annex V to Implementing Regulation (EU) 2020/2235 should therefore be amended accordingly.

(7)

Implementing Regulation (EU) 2020/2235 should therefore be amended accordingly.

(8)

In order to avoid any disruption to trade as regards the entry into the Union of consignments of certain fishery products, highly refined products of animal origin, and shelf-stable composite products, certificate/attestation issued in accordance with Implementing Regulation (EU) 2020/2235, issued prior to the amendments made by this Regulation, should continue to be authorised during a transitional period provided that such certificate/attestation was issued no later than 15 April 2023.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes III and V to Implementing Regulation (EU) 2020/2235 are amended in accordance with the Annex to this Regulation.

Article 2

1.   For a transitional period until 15 July 2023, consignments of certain fishery products and highly refined products of animal origin accompanied by the relevant model animal health/official certificates or official certificates issued in accordance with the models set out in Chapters 30, 31 and 46 of Annex III to Implementing Regulation (EU) 2020/2235 as applicable before the amendments made to that Implementing Regulation by this Implementing Regulation, shall continue to be authorised for the entry into the Union, provided that such certificate was issued no later than 15 April 2023.

2.   For a transitional period until 15 July 2023, consignments of shelf-stable composite products accompanied by the private attestation issued in accordance with the model set out in Annex V to Implementing Regulation (EU) 2020/2235 as applicable before the amendments made to that Implementing Regulation by this Implementing Regulation, shall continue to be authorised for the entry into the Union, provided that such attestation was issued no later than 15 April 2023.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 December 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)   OJ L 139, 30.4.2004, p. 55.

(2)   OJ L 84, 31.3.2016, p. 1.

(3)   OJ L 95, 7.4.2017, p. 1.

(4)  Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).

(5)  Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption (OJ L 131, 17.5.2019, p. 18).

(6)  Commission Delegated Regulation (EU) 2022/2258 of 9 September 2022 amending and correcting Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council on specific hygiene requirements for food of animal origin as regards fishery products, eggs and certain highly refined products, and amending Commission Delegated Regulation (EU) 2019/624 as regards certain bivalve molluscs (OJ L 299, 18.11.2022, p. 5).

(7)  Commission Delegated Regulation (EU) 2019/624 of 8 February 2019 concerning specific rules for the performance of official controls on the production of meat and for production and relaying areas of live bivalve molluscs in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 131, 17.5.2019, p. 1).

(8)  Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).

(9)  Commission Decision 2011/163/EU of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC (OJ L 70, 17.3.2011, p. 40).

(10)  Commission Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 118).


ANNEX

Annexes III and V to Implementing Regulation (EU) 2020/2235 are amended as follows:

(1)

Annex III is amended as follows:

(a)

in the introductory table setting out the list of the model animal health/official certificates and model official certificates for the entry into the Union contained in that Annex, the Section concerning the model official certificate for highly refined chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids intended for human consumption, is replaced by the following:

highly refined products as described in Annex III, Section XVI of Regulation (EC) No 853/2004, intended for human consumption

HRP

Chapter 46: Model official certificate for the entry into the Union of highly refined products as described in Annex III, Section XVI of Regulation (EC) No 853/2004, intended for human consumption’

(b)

Chapters 30 and 31 are replaced by the following:

CHAPTER 30

MODEL OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF FISHERY PRODUCTS OR FISHERY PRODUCTS DERIVED FROM BIVALVE MOLLUSCS INTENDED FOR HUMAN CONSUMPTION ENTERING THE UNION DIRECTLY FROM A REEFER, FREEZER OR FACTORY VESSEL FLYING THE FLAG OF A THIRD COUNTRY AS PROVIDED FOR IN ARTICLE 11(3) OF DELEGATED REGULATION (EU) 2019/625 (MODEL FISH/MOL-CAP)

Image 1

COUNTRY

Certificate model FISH/MOL-CAP

 

II. Health information

II.a

Certificate reference

II.b

IMSOC reference

Part II: Certification

II.1

Public health attestation

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 Council (1), Regulation (EC) No 852/2004 of the European Parliament and of the Council (2), Regulation (EC) No 853/2004 of the European Parliament and of the Council (3) and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation) (4) and hereby certify that the fishery products or fishery products derived from live bivalve molluscs/live echinoderms/live tunicates/live marine gastropods described in Part I:

(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.

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 official certificate include the United Kingdom in respect of Northern Ireland.

This 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.2:

A unique document number according to your own classification.

Box reference I.5:

The name and address (street, town and post code) of the physical or legal person to whom the consignment is imported directly to in the Member State of destination.

Box reference I.7:

The country whose flag is being flown by the vessel issuing this document.

Box reference I.11:

The name of the vessel and approval number as listed in accordance with Article 10 of Commission Delegated Regulation (EU) 2019/625 (9) from which the fishery products are directly imported.

Box reference I.20:

Tick "Canning industry" for whole fish initially frozen in brine at -9°C or at a temperature higher than -18°C and intended for canning in accordance with the requirements of Section VIII, Chapter I, point II(7), of Annex III to Regulation (EC) No 853/2004. Tick "Products for human consumption" or “Further processing” for the other cases.

Box reference I.27:

Insert the appropriate Harmonised System (HS) code(s) using one or more of the following headings: 0301 , 0302 , 0303 , 0304 , 0305 , 0306 , 0307 , 0308 , 0511 , 1504 , 1516 , 1518 , 1603 , 1604 , 1605 or 2106 .

Box reference I.27:

Description of consignment:

Treatment type”: specify whether chilled, frozen or processed.

 

Captain of the vessel

Name (in capital letters):

Date:

Stamp:

Signature:

CHAPTER 31

MODEL ANIMAL HEALTH/OFFICIAL CERTIFICATE FOR THE ENTRY IN THE UNION OF LIVE BIVALVE MOLLUSCS, ECHINODERMS, TUNICATES, MARINE GASTROPODS AND PRODUCTS OF ANIMAL ORIGIN FROM THESE ANIMALS INTENDED FOR HUMAN CONSUMPTION (MODEL MOL-HC)

Image 2

Image 3

COUNTRY

Certificate model MOL-HC

 

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 Council (10), Regulation (EC) No 852/2004 of the European Parliament and of the Council (11), Regulation (EC) No 853/2004 of the European Parliament and of the Council (12) and Regulation (EU) 2017/625 of the European Parliament and of the Council (Official Controls Regulation) (13) 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) 2021/405 (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).

(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) 2020/692 (22) 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) 2021/404 (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.

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) 2020/689 (24) 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) 2021/260 (25).]]

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) 2020/691 (26), 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)