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Commission Implementing Regulation (EU) 2025/636 of 25 March 2025 amending Annexes III and V to Implementing Regulation (EU) 2020/2235 as regards model animal health certificates, model official certificates, model animal health/official certificates and private attestation, for the entry into the Union or transit through the Union to a third country of consignments of certain categories of animals and goods intended for human consumption

Type Implementing Regulation

Publication 2025-04-30

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.

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⁽¹⁾ [II.1. Public health attestation (Delete 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, Regulation (EC) No 852/2004 of the European Parliament and of the Council, Regulation (EC) No 853/2004 of the European Parliament and of the Council and Regulation (EU) 2017/625 of the European Parliament and of the Council and hereby certify that the [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] ⁽⁴⁾ described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in (a) region(s)s or (a) country(ries) which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of [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] ⁽⁴⁾, and is/are listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405; (b) come from establishments 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 listed as Union approved establishments; (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⁾ either [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;] ⁽⁴⁾ or [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;] (e) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, [Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾ and the criteria laid down in Commission Regulation (EC) No 2073/2005; (f) have been packaged, stored and transported in compliance with [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] ⁽⁴⁾; (g) have been marked and labelled in accordance with [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] ⁽⁴⁾; (h) are Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, which comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (i) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627 as [A] ⁽⁴⁾ [B] ⁽⁴⁾ or [C] ⁽⁴⁾ 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); (j) have satisfactorily undergone the official controls laid down in [Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624] ⁽⁴⁾ [Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627] ⁽⁴⁾; (k) fulfil the guarantees covering aquaculture provided by the control plan submitted in accordance with Article 6(2) of Commission Delegated Regulation (EU) 2022/2292 and the third country or region thereof of the origin of the animals and products described in Part I is listed in Annex -I to Implementing Regulation (EU) 2021/405 and marked with an “M” for the category “aquaculture”.] ^{(4) (14)} [II.1a. Attestation as regards Commission Delegated Regulation (EU) 2023/905 (Delete when the Union is not the final destination of the live bivalve molluscs, live echinoderms, live tunicates, live marine gastropods of on-land aquaculture origin and the products of animal origin derived therefrom) I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EU) 2019/6 of the European Parliament and of the Council and Delegated Regulation (EU) 2023/905 and hereby certify that the [live bivalve molluscs] ⁽⁴⁾ [live echinoderms] ⁽⁴⁾ [live tunicates] ⁽⁴⁾ [live marine gastropods] ⁽⁴⁾ of on-land aquaculture origin and the products of animal origin derived therefrom described in Part I were produced in accordance with these requirements, and in particular, that the aquaculture animals from which the products have been derived have not been administered antimicrobial medicinal products for growth promotion or yield increase or antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 as set out in Article 3 of Delegated Regulation (EU) 2023/905 and originate from a third country or region thereof listed in the Annex to Commission Implementing Regulation (EU) 2024/2598.] ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of listed ⁽³⁾ 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 [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ meet the following animal health requirements: II.2.1.1. they originate from [an establishment] ⁽⁴⁾ [a habitat] ⁽⁴⁾ 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 and emerging diseases; II.2.1.2. the [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] ⁽⁴⁾ under a national programme for the eradication of diseases, including the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases. ⁽⁴⁾ [II.2.2. The [aquaculture animals described in Part I] ⁽⁴⁾ [products of animal origin from aquaculture animals other than live aquaculture animals described in Part I, have been obtained from animals which] ⁽⁴⁾ meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is [registered] ⁽⁴⁾ [approved] ⁽⁴⁾ 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: (a) the species, categories and number of aquaculture animals in the establishment; (b) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (c) 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 listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I have been obtained from animals which] ⁽⁴⁾ meet the following animal health requirements: ^{(4) (8)} either [II.2.3.1. they are subject to the requirements referred to in point II.2.4, and originate from a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone] ⁽⁴⁾ [compartment] ⁽⁴⁾ with code … ⁽⁵⁾ 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 for the entry into the Union of those [aquatic animals] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals] ⁽⁴⁾;] ^{(4) (6)} or [II.2.3.1. they are subject to the requirements referred to in point II.2.4, and originate from a [country] ⁽⁵⁾ [territory] ⁽⁵⁾ [zone] ⁽⁵⁾ [compartment] ⁽⁵⁾ with code … ⁽⁷⁾ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXII to Commission Implementing Regulation (EU) 2021/404 for the transit though the Union of [aquatic animals] ⁽⁵⁾ [products of animal origin from aquatic animals other than live aquatic animals] ⁽⁵⁾ intended for a destination outside the Union;] ^{(4) (8)} [II.2.3.2. they are aquatic animals that have undergone clinical inspection in accordance with Article 166 of Delegated Regulation (EU) 2020/692 within 72 hours prior to the time of loading for dispatch to the Union, and during the inspection, they showed no clinical symptoms of transmissible disease, and, according to the relevant records of the establishment, there was no indication of disease problems;] ⁽⁸⁾ [II.2.3.3. they are aquatic animals which are dispatched to the Union directly from the place of origin;] II.2.3.4. they have not been in contact with aquatic animals of a lower health status. ^{(4) (8)} either [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for listed ⁽³⁾ species for infection with Mikrocytos mackini or infection with Perkinsus marinus The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ originate from a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone] ⁽⁴⁾ [compartment] ⁽⁴⁾ declared free from [infection with Mikrocytos mackini] ⁽⁴⁾ [infection with Perkinsus marinus] ⁽⁴⁾ 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, and in the case of aquatic animals, all listed ⁽³⁾ species for the relevant disease(s) are: (a) introduced from another country or territory, or zone or compartment thereof which has been declared free from the same disease(s); (b) not vaccinated against [that] ⁽⁴⁾ [those] ⁽⁴⁾ disease(s).] ^{(4) (9)} [II.2.4.2. Requirements for listed ⁽³⁾ species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ originate from a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone,] ⁽⁴⁾ [compartment] ⁽⁴⁾ declared free from [infection with Marteilia refringens] ⁽⁴⁾ [infection with Bonamia exitiosa] ⁽⁴⁾ [infection with Bonamia ostreae] ⁽⁴⁾ in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689, and in the case of aquatic animals, all listed ⁽³⁾ species for the relevant disease(s) are: (a) introduced from another country or territory, or zone or compartment thereof which has been declared free from the same disease(s); (b) not vaccinated against [that] ⁽⁴⁾ [those] ⁽⁴⁾ disease(s).] ^{(4) (10)} [II.2.4.3. Requirements for species ⁽¹¹⁾ susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ originate from a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone] ⁽⁴⁾ [compartment] ⁽⁴⁾ 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 [Annex I] ⁽⁴⁾ [Annex II] ⁽⁴⁾ to Commission Implementing Decision (EU) 2021/260.]] ^{(4) (8)} or [II.2.4. Specific health requirements The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ 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, 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 [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ originate from [an establishment] ⁽⁴⁾ [a habitat] ⁽⁴⁾ where: (a) there were no abnormal mortalities with an undetermined cause; (b) the animals have not been in contact with aquatic animals of listed ⁽³⁾ 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 described in 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 aquatic animals are transported in water, the water is not changed in a third country or territory, or zone or compartment thereof which is not listed for entry into the Union of the particular species and category of aquatic animals; II.2.6.2. the aquatic animals are not transported under conditions that jeopardise their health status, in particular: (a) when the aquatic animals are transported in water, it does not alter their health status; (b) 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; (c) the [container] ⁽⁴⁾ [well-boat] ⁽⁴⁾ is [previously unused] ⁽⁴⁾ [cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the third country or territory of origin] ⁽⁴⁾, 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 [container] ⁽⁴⁾ [well-boat] ⁽⁴⁾ together with aquatic animals which are of a lower health status or which are not intended for the entry into the Union; II.2.6.4. where a water exchange is necessary in a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone] ⁽⁴⁾ [compartment] ⁽⁴⁾ which is listed for the entry into the Union of the particular species and category of aquatic animals, it only occurs [in the case of transport on land, at water exchange points approved by the competent authority of the third country or 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 enroute from the place of origin to the place of destination in the Union] ⁽⁴⁾. II.2.7. Labelling requirements Arrangements have been made to identify and label the [means of transport] ⁽⁴⁾ [containers] ⁽⁴⁾ in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by [a legible and visible label on the exterior of the container] ⁽⁴⁾ [an entry in the ship’s manifest when transported by well-boat] ⁽⁴⁾, 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 aquatic animals in each container for each of the species present; (d) the following statement: “live molluscs intended for human consumption in the 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: “products of animal origin from molluscs, other than live molluscs, intended for further processing in the Union”.] ^{(4) (12)} 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 Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 of 24 March 2023, OJ L 102, 17.4.2023, p. 87) in conjunction with Annex 2 to that Framework, references to the Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for the entry into the Union of live bivalve 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 Council. “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 point II.2.4 of this animal health/official certificate applies shall originate from a third country or territory, or zone or compartment thereof which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Point II.2.4 of this animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a third 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 Commission Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8 : Indicate the production area, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 of this animal health/official certificate shall not apply to third countries or territories with the 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 shall be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882; 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 point 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 note (8). ⁽⁵⁾ Code of the third country or territory, or zone or compartment thereof as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Only applicable to consignments transiting through the Union and intended for a destination outside the Union, originating from third country or territory, or zone, or compartment thereof listed in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404 as authorised for transit through the Union of aquatic animals or products of animal origin from aquatic animals other than live aquatic animals accompanied by an animal health certificate corresponding to the present model in accordance with column 5 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁷⁾ Code of the third country or territory, or zone, or compartment thereof as it appears in column 2 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁸⁾ Points II.2.3.1, II.2.3.2, II.2.3.3 and II.2.4 of this animal health/official certificate shall not apply and shall 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. ⁽⁹⁾ Applicable only when the Member State or zone or compartment thereof 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. ⁽¹⁰⁾ 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. ⁽¹¹⁾ Susceptible species as referred to in column 2 of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹²⁾ Shall apply only to consignments of live aquatic animals. ⁽¹³⁾ To be signed by: (a) an official veterinarian when Part II.2 Animal health attestation is not deleted, (b) a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. ⁽¹⁴⁾ Applicable to consignments entering the Union as from 3 September 2026.

⁽¹⁾ [II.1. Public health attestation (Delete 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, Regulation (EC) No 852/2004 of the European Parliament and of the Council, Regulation (EC) No 853/2004 of the European Parliament and of the Council and Regulation (EU) 2017/625 of the European Parliament and of the Council and hereby certify that the [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] ⁽⁴⁾ described in Part I were produced in accordance with these requirements, and in particular that they: (a) have been obtained in (a) region(s)s or (a) country(ries) which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of [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] ⁽⁴⁾, and is/are listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405; (b) come from establishments 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 listed as Union approved establishments; (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⁾ either [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;] ⁽⁴⁾ or [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;] (e) satisfy the health standards laid down in Section VII, Chapter V, of Annex III to Regulation (EC) No 853/2004, [Section VIII, Chapter V, of Annex III to Regulation (EC) No 853/2004] ⁽⁴⁾ and the criteria laid down in Commission Regulation (EC) No 2073/2005; (f) have been packaged, stored and transported in compliance with [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] ⁽⁴⁾; (g) have been marked and labelled in accordance with [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] ⁽⁴⁾; (h) are Pectinidae, marine gastropods and echinoderms that are not filter feeders harvested outside classified production areas, which comply with the specific requirements laid down in Section VII, Chapter IX, of Annex III to Regulation (EC) No 853/2004; (i) come from a production area classified in accordance with Article 52 of Commission Implementing Regulation (EU) 2019/627 as [A] ⁽⁴⁾ [B] ⁽⁴⁾ or [C] ⁽⁴⁾ 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); (j) have satisfactorily undergone the official controls laid down in [Articles 51 to 66 of Implementing Regulation (EU) 2019/627 or in Article 11 of Commission Delegated Regulation (EU) 2019/624] ⁽⁴⁾ [Articles 69, 70 and 71 of Implementing Regulation (EU) 2019/627] ⁽⁴⁾; (k) fulfil the guarantees covering aquaculture provided by the control plan submitted in accordance with Article 6(2) of Commission Delegated Regulation (EU) 2022/2292 and the third country or region thereof of the origin of the animals and products described in Part I is listed in Annex -I to Implementing Regulation (EU) 2021/405 and marked with an “M” for the category “aquaculture”.] ^{(4) (14)} [II.1a. Attestation as regards Commission Delegated Regulation (EU) 2023/905 (Delete when the Union is not the final destination of the live bivalve molluscs, live echinoderms, live tunicates, live marine gastropods of on-land aquaculture origin and the products of animal origin derived therefrom) I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EU) 2019/6 of the European Parliament and of the Council and Delegated Regulation (EU) 2023/905 and hereby certify that the [live bivalve molluscs] ⁽⁴⁾ [live echinoderms] ⁽⁴⁾ [live tunicates] ⁽⁴⁾ [live marine gastropods] ⁽⁴⁾ of on-land aquaculture origin and the products of animal origin derived therefrom described in Part I were produced in accordance with these requirements, and in particular, that the aquaculture animals from which the products have been derived have not been administered antimicrobial medicinal products for growth promotion or yield increase or antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 as set out in Article 3 of Delegated Regulation (EU) 2023/905 and originate from a third country or region thereof listed in the Annex to Commission Implementing Regulation (EU) 2024/2598.] ⁽²⁾ [II.2. Animal health attestation for live bivalve molluscs of listed ⁽³⁾ 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 [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ meet the following animal health requirements: II.2.1.1. they originate from [an establishment] ⁽⁴⁾ [a habitat] ⁽⁴⁾ 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 and emerging diseases; II.2.1.2. the [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] ⁽⁴⁾ under a national programme for the eradication of diseases, including the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases. ⁽⁴⁾ [II.2.2. The [aquaculture animals described in Part I] ⁽⁴⁾ [products of animal origin from aquaculture animals other than live aquaculture animals described in Part I, have been obtained from animals which] ⁽⁴⁾ meet the following requirements: II.2.2.1. they come from an aquaculture establishment which is [registered] ⁽⁴⁾ [approved] ⁽⁴⁾ 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: (a) the species, categories and number of aquaculture animals in the establishment; (b) the movements of aquatic animals into, and aquaculture animals out of, the establishment; (c) 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 listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases, at a frequency that is proportionate to the risk posed by the establishment.] II.2.3. General animal health requirements The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I have been obtained from animals which] ⁽⁴⁾ meet the following animal health requirements: ^{(4) (8)} either [II.2.3.1. they are subject to the requirements referred to in point II.2.4, and originate from a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone] ⁽⁴⁾ [compartment] ⁽⁴⁾ with code … ⁽⁵⁾ 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 for the entry into the Union of those [aquatic animals] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals] ⁽⁴⁾;] ^{(4) (6)} or [II.2.3.1. they are subject to the requirements referred to in point II.2.4, and originate from a [country] ⁽⁵⁾ [territory] ⁽⁵⁾ [zone] ⁽⁵⁾ [compartment] ⁽⁵⁾ with code … ⁽⁷⁾ which, at the date of issue of this animal health/official certificate, is listed in Part 1 of Annex XXII to Commission Implementing Regulation (EU) 2021/404 for the transit though the Union of [aquatic animals] ⁽⁵⁾ [products of animal origin from aquatic animals other than live aquatic animals] ⁽⁵⁾ intended for a destination outside the Union;] ^{(4) (8)} [II.2.3.2. they are aquatic animals that have undergone clinical inspection in accordance with Article 166 of Delegated Regulation (EU) 2020/692 within 72 hours prior to the time of loading for dispatch to the Union, and during the inspection, they showed no clinical symptoms of transmissible disease, and, according to the relevant records of the establishment, there was no indication of disease problems;] ⁽⁸⁾ [II.2.3.3. they are aquatic animals which are dispatched to the Union directly from the place of origin;] II.2.3.4. they have not been in contact with aquatic animals of a lower health status. ^{(4) (8)} either [II.2.4. Specific health requirements ⁽⁴⁾ [II.2.4.1. Requirements for listed ⁽³⁾ species for infection with Mikrocytos mackini or infection with Perkinsus marinus The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ originate from a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone] ⁽⁴⁾ [compartment] ⁽⁴⁾ declared free from [infection with Mikrocytos mackini] ⁽⁴⁾ [infection with Perkinsus marinus] ⁽⁴⁾ 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, and in the case of aquatic animals, all listed ⁽³⁾ species for the relevant disease(s) are: (a) introduced from another country or territory, or zone or compartment thereof which has been declared free from the same disease(s); (b) not vaccinated against [that] ⁽⁴⁾ [those] ⁽⁴⁾ disease(s).] ^{(4) (9)} [II.2.4.2. Requirements for listed ⁽³⁾ species for infection with Marteilia refringens, infection with Bonamia exitiosa or infection with Bonamia ostreae The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ originate from a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone,] ⁽⁴⁾ [compartment] ⁽⁴⁾ declared free from [infection with Marteilia refringens] ⁽⁴⁾ [infection with Bonamia exitiosa] ⁽⁴⁾ [infection with Bonamia ostreae] ⁽⁴⁾ in accordance with Part II, Chapter 4, of Delegated Regulation (EU) 2020/689, and in the case of aquatic animals, all listed ⁽³⁾ species for the relevant disease(s) are: (a) introduced from another country or territory, or zone or compartment thereof which has been declared free from the same disease(s); (b) not vaccinated against [that] ⁽⁴⁾ [those] ⁽⁴⁾ disease(s).] ^{(4) (10)} [II.2.4.3. Requirements for species ⁽¹¹⁾ susceptible to infection with Ostreid herpes virus 1 μvar (OsHV-1 μvar) The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ originate from a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone] ⁽⁴⁾ [compartment] ⁽⁴⁾ 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 [Annex I] ⁽⁴⁾ [Annex II] ⁽⁴⁾ to Commission Implementing Decision (EU) 2021/260.]] ^{(4) (8)} or [II.2.4. Specific health requirements The [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ 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, 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 [aquatic animals described in Part I] ⁽⁴⁾ [products of animal origin from aquatic animals other than live aquatic animals described in Part I, have been obtained from animals which] ⁽⁴⁾ originate from [an establishment] ⁽⁴⁾ [a habitat] ⁽⁴⁾ where: (a) there were no abnormal mortalities with an undetermined cause; (b) the animals have not been in contact with aquatic animals of listed ⁽³⁾ 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 described in 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 aquatic animals are transported in water, the water is not changed in a third country or territory, or zone or compartment thereof which is not listed for entry into the Union of the particular species and category of aquatic animals; II.2.6.2. the aquatic animals are not transported under conditions that jeopardise their health status, in particular: (a) when the aquatic animals are transported in water, it does not alter their health status; (b) 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; (c) the [container] ⁽⁴⁾ [well-boat] ⁽⁴⁾ is [previously unused] ⁽⁴⁾ [cleaned and disinfected in accordance with a protocol and with products approved by the competent authority of the third country or territory of origin] ⁽⁴⁾, 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 [container] ⁽⁴⁾ [well-boat] ⁽⁴⁾ together with aquatic animals which are of a lower health status or which are not intended for the entry into the Union; II.2.6.4. where a water exchange is necessary in a [country] ⁽⁴⁾ [territory] ⁽⁴⁾ [zone] ⁽⁴⁾ [compartment] ⁽⁴⁾ which is listed for the entry into the Union of the particular species and category of aquatic animals, it only occurs [in the case of transport on land, at water exchange points approved by the competent authority of the third country or 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 enroute from the place of origin to the place of destination in the Union] ⁽⁴⁾. II.2.7. Labelling requirements Arrangements have been made to identify and label the [means of transport] ⁽⁴⁾ [containers] ⁽⁴⁾ in accordance with Article 169 of Delegated Regulation (EU) 2020/692 and specifically that: II.2.7.1. the consignment is identified by [a legible and visible label on the exterior of the container] ⁽⁴⁾ [an entry in the ship’s manifest when transported by well-boat] ⁽⁴⁾, 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 aquatic animals in each container for each of the species present; (d) the following statement: “live molluscs intended for human consumption in the 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: “products of animal origin from molluscs, other than live molluscs, intended for further processing in the Union”.] ^{(4) (12)} 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 Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 of 24 March 2023, OJ L 102, 17.4.2023, p. 87) in conjunction with Annex 2 to that Framework, references to the Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for the entry into the Union of live bivalve 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 Council. “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 point II.2.4 of this animal health/official certificate applies shall originate from a third country or territory, or zone or compartment thereof which appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. Point II.2.4 of this animal health/official certificate shall not apply to the following aquatic animals, and they may therefore originate from a third 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 Commission Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8 : Indicate the production area, except for Pectinidae, marine gastropods and echinoderms harvested outside classified production areas. Part II: ⁽¹⁾ Part II.1 of this animal health/official certificate shall not apply to third countries or territories with the 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 shall be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882; 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 point 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 note (8). ⁽⁵⁾ Code of the third country or territory, or zone or compartment thereof as it appears in column 2 of the table in Part 1 of Annex XXI to Implementing Regulation (EU) 2021/404. ⁽⁶⁾ Only applicable to consignments transiting through the Union and intended for a destination outside the Union, originating from third country or territory, or zone, or compartment thereof listed in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404 as authorised for transit through the Union of aquatic animals or products of animal origin from aquatic animals other than live aquatic animals accompanied by an animal health certificate corresponding to the present model in accordance with column 5 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁷⁾ Code of the third country or territory, or zone, or compartment thereof as it appears in column 2 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁸⁾ Points II.2.3.1, II.2.3.2, II.2.3.3 and II.2.4 of this animal health/official certificate shall not apply and shall 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. ⁽⁹⁾ Applicable only when the Member State or zone or compartment thereof 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. ⁽¹⁰⁾ 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. ⁽¹¹⁾ Susceptible species as referred to in column 2 of the table in Annex III to Implementing Decision (EU) 2021/260. ⁽¹²⁾ Shall apply only to consignments of live aquatic animals. ⁽¹³⁾ To be signed by: (a) an official veterinarian when Part II.2 Animal health attestation is not deleted, (b) a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. ⁽¹⁴⁾ Applicable to consignments entering the Union as from 3 September 2026.


[Official veterinarian] ^{(4) (13)}/[Certifying officer] ^{(4) (13)}	[Official veterinarian] ^{(4) (13)}/[Certifying officer] ^{(4) (13)}	[Official veterinarian] ^{(4) (13)}/[Certifying officer] ^{(4) (13)}	[Official veterinarian] ^{(4) (13)}/[Certifying officer] ^{(4) (13)}
Name (in capital letters)
Date		Qualification and title
Stamp		Signature

CHAPTER 32 **MODEL OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF PROCESSED BIVALVE MOLLUSCS INTENDED FOR HUMAN CONSUMPTION BELONGING TO THE SPECIES ACANTHOCARDIA TUBERCULATUM (MODEL MOL-AT)**

The undersigned certifying officer hereby certifies that the processed bivalve molluscs of the species Acanthocardia tuberculatum, certified in the official certificate reference No* …

(1) were harvested in production areas clearly identified, classified and monitored by the competent authorities in accordance with Articles 52 and 59 of Commission Implementing Regulation (EU) 2019/627 and where the paralytic shellfish poisoning (PSP) toxin quantity is lower than 300 μg for 100g;

(2) were transported in containers or vehicles sealed by the competent authority, directly to the establishment

…

(name and official approval number of the establishment, authorised specially by the competent authorities to carry out their treatment);

(3) were accompanied while being transported to this establishment by a document issued by the competent authorities which authorise the transport, attesting to the nature and quantity of the product, production area of origin and establishment of destination;

(4) were subjected to the heat treatment outlined in the Annex to Commission Decision 96/77/EC;

(5) after heat treatment they do not contain paralytic shellfish poisoning (PSP) toxins exceeding the limit of 800 micrograms of saxitoxin equivalents diHCl per kilogram using the method described in the Standard EN 14526 or any other internationally recognised validated method not entailing the use of a live animal in accordance with Annex V, Chapter I, to Commission Implementing Regulation (EU) 2019/627, as demonstrated by the attached analytical report(s) of the test carried out on each lot included in the consignment covered by this official certificate.

The undersigned certifying officer hereby certifies that the competent authorities have verified that the “own” checks carried out in the establishment referred to in point (2) are specifically applied to the heat treatment referred to in point (4).

The undersigned certifying officer hereby declares that he/she is aware of the requirements of Decision 96/77/EC and that the attached analytical report(s) correspond(s) to the test carried out on the products after processing.

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 Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 of 24 March 2023, OJ L 102, 17.4.2023, p. 87) in conjunction with Annex 2 to that Framework, references to the Union in this official certificate include the United Kingdom in respect of Northern Ireland.

- Please introduce the number of the MOL-HC certificate accompanying the processed bivalve molluscs of the species Acanthocardia tuberculatum.


Certifying officer	Certifying officer	Certifying officer	Certifying officer
Name (in capital letters)
Date		Qualification and title
Stamp		Signature

CHAPTER 33 MODEL ANIMAL HEALTH/OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF RAW MILK INTENDED FOR HUMAN CONSUMPTION (MODEL MILK-RM)

Part I: Description of consignment


COUNTRY	Animal health/official certificate to the EU

---	---
I.1	Consignor/Exporter
	Name
	Address
	Address
	Country
I.5	Consignee/Importer
	Name
	Address
	Country
I.7	Country of origin
I.8	Region of origin
I.11	Place of dispatch
	Name
	Address
	Country
I.13	Place of loading

---	---
I.15	Means of transport
	☐ Aircraft
	☐ Railway
	Identification
	Identification

---	---
I.18	Transport conditions
I.19	Container number/Seal number
	Container No
I.20	Certified as or for
	☐ Products for human consumption

---	---
I.21	☐ For transit
	Third country

---	---
I.24	Total number of packages

---	---
I.27	Description of consignment
CN code	Species





☐ Final consumer

Part II: Certification


COUNTRY	COUNTRY	Certificate model MILK-RM	Certificate model MILK-RM	Certificate model MILK-RM	Certificate model MILK-RM
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference


⁽¹⁾ [II.1. Public health attestation (Delete when the Union is not the final destination of the raw milk) 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, Regulation (EC) No 852/2004 of the European Parliament and of the Council, Regulation (EC) No 853/2004 of the European Parliament and of the Council and Regulation (EU) 2017/625 of the European Parliament and of the Council and Commission Implementing Regulation (EU) 2019/627 and hereby certify that the raw milk described in Part I was produced in accordance with these requirements, and in particular that: (a) it comes from holdings registered in accordance with Regulation (EC) No 852/2004 and checked in accordance with Articles 49 and 50 of Implementing Regulation (EU) 2019/627; (b) it was produced, collected, cooled, stored and transported in accordance with the hygiene conditions laid down in Section IX, Chapter I, of Annex III to Regulation (EC) No 853/2004; (c) it meets the plate and somatic cell count criteria laid down in Section IX, Chapter I, of Annex III to Regulation (EC) No 853/2004; (d) it comes from animals belonging to herds officially free of tuberculosis and free or officially free of brucellosis; (e) it fulfils the guarantees covering animals and products thereof provided by the control plan submitted in accordance with Article 6(2) of Commission Delegated Regulation (EU) 2022/2292 and the third country or region thereof of its origin is listed in Annex -I to Commission Implementing Regulation (EU) 2021/405 and marked with an “X” for the category “milk”; (f) pursuant to testing for antibiotic residues carried out by the food business operator in accordance with the requirements of Section IX, Chapter I, Part III, point 4, of Annex III to Regulation (EC) No 853/2004, it complies with the maximum residue limits for residues of antibacterial veterinary medicinal products laid down in the Annex to Commission Regulation (EU) No 37/2010.] ^{(1) (6)} [II.1a. Attestation as regards Commission Delegated Regulation (EU) 2023/905 (Delete when the Union is not the final destination of the raw milk) I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EU) 2019/6 of the European Parliament and of the Council and Delegated Regulation (EU) 2023/905 and hereby certify that the raw milk described in Part I was produced in accordance with these requirements, and in particular that, the animals from which the raw milk has been obtained have not been administered antimicrobial medicinal products for growth promotion or yield increase or antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 as set out in Article 3 of Delegated Regulation (EU) 2023/905 and originate from a third country or region thereof listed in the Annex to Commission Implementing Regulation (EU) 2024/2598.] ⁽¹⁾ [II.2. Animal health attestation (Delete when the raw milk is derived from solipeds, leporidae or wild land mammals other than ungulates) The raw milk described in Part I: ⁽¹⁾ either [II.2.1. originates from the zone with code … ⁽²⁾ which, at the date of issue of this animal health/official certificate is authorised for the entry into the Union of milk and listed in Part 1 of Annex XVII to Commission Implementing Regulation (EU) 2021/404, and in which foot and mouth disease and infection with rinderpest virus have not been reported for the last 12 months prior to the date of milking, and vaccination against these diseases has not been carried out during that period;] ^{(1) (3)} or [II.2.1. originates from the zone with code … ⁽⁴⁾ which, at the date of issue of this animal health/official certificate is authorised for the transit through the Union of milk intended for a destination outside the Union and is listed in Part 1 of Annex XXII to Commission Implementing Regulation (EU) 2021/404;] II.2.2. has been obtained from animals of the species [Bos taurus,] ⁽¹⁾ [Ovis aries,] ⁽¹⁾ [Capra hircus,] ⁽¹⁾ [Bubalus bubalis,] ⁽¹⁾ [Camelus dromedarius] ⁽¹⁾ that: ⁽¹⁾ either [have remained in the zone referred to under point II.2.1 since birth, or for at least 3 months prior to the date of milking;] ⁽¹⁾ and/or [were introduced in the zone referred to under point II.2.1 from: ⁽¹⁾ either [another third country or territory, or zone thereof which is listed for entry into the Union of milk, colostrum or colostrum-based products, and the animals remained there for at least 3 months prior to the date of milking;]] ⁽¹⁾ and/or [Member States;]] II.2.3. has been obtained from animals coming from establishments: (a) which are registered by and are under the control of the competent authority of the third country or territory and have a system in place to maintain and to keep records in accordance with Article 8 of Commission Delegated Regulation (EU) 2020/692; (b) which receive 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 listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases; (c) which were not subject to national restriction measures for animal health reasons, including the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases, at the date of milking.] 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 Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 of 24 March 2023, OJ L 102, 17.4.2023, p. 87) in conjunction with Annex 2 to that Framework, references to the Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for the entry into the Union of raw milk, including when the Union is not the final destination of such milk. 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 Commission Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8 : Provide the code of the zone as appearing in column 2 of the table in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404. Box reference I.11 : Name, address and approval number of the establishment of dispatch. Box reference I.15 : Registration number (railway wagons or container and road vehicle), flight number (aircraft) or name (vessel) shall be provided. In the case of unloading and reloading, the consignor shall inform the border control post of entry into the Union. Box reference I.19 : For the containers or boxes, the container number and the seal number (if applicable) shall be included. Box reference I.27 : “CN code”: Indicate the appropriate Harmonised System (HS) code(s) of the World Customs Organisation under the following headings: 0401 , 0402 or 0403 . “Manufacturing plant”: Introduce the approval number of the production holding(s), collection centre or standardization centre approved for the entry into the Union. Part II: ⁽¹⁾ Delete if not applicable. ⁽²⁾ Code of the zone in accordance with column 2 of the table in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404. ⁽³⁾ Only applicable to consignments transiting through the Union and intended for a destination outside the Union, originating from third country or territory, or zone thereof listed in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404 as authorised for transit through the Union of milk accompanied by an animal health certificate corresponding to the present model certificate in accordance with column 5 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁴⁾ Code of the zone in accordance with column 2 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁵⁾ To be signed by: (a) an official veterinarian when Part II.2 Animal health attestation is not deleted, (b) a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. ⁽⁶⁾ Applicable to consignments entering the Union as from 3 September 2026.

⁽¹⁾ [II.1. Public health attestation (Delete when the Union is not the final destination of the raw milk) 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, Regulation (EC) No 852/2004 of the European Parliament and of the Council, Regulation (EC) No 853/2004 of the European Parliament and of the Council and Regulation (EU) 2017/625 of the European Parliament and of the Council and Commission Implementing Regulation (EU) 2019/627 and hereby certify that the raw milk described in Part I was produced in accordance with these requirements, and in particular that: (a) it comes from holdings registered in accordance with Regulation (EC) No 852/2004 and checked in accordance with Articles 49 and 50 of Implementing Regulation (EU) 2019/627; (b) it was produced, collected, cooled, stored and transported in accordance with the hygiene conditions laid down in Section IX, Chapter I, of Annex III to Regulation (EC) No 853/2004; (c) it meets the plate and somatic cell count criteria laid down in Section IX, Chapter I, of Annex III to Regulation (EC) No 853/2004; (d) it comes from animals belonging to herds officially free of tuberculosis and free or officially free of brucellosis; (e) it fulfils the guarantees covering animals and products thereof provided by the control plan submitted in accordance with Article 6(2) of Commission Delegated Regulation (EU) 2022/2292 and the third country or region thereof of its origin is listed in Annex -I to Commission Implementing Regulation (EU) 2021/405 and marked with an “X” for the category “milk”; (f) pursuant to testing for antibiotic residues carried out by the food business operator in accordance with the requirements of Section IX, Chapter I, Part III, point 4, of Annex III to Regulation (EC) No 853/2004, it complies with the maximum residue limits for residues of antibacterial veterinary medicinal products laid down in the Annex to Commission Regulation (EU) No 37/2010.] ^{(1) (6)} [II.1a. Attestation as regards Commission Delegated Regulation (EU) 2023/905 (Delete when the Union is not the final destination of the raw milk) I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EU) 2019/6 of the European Parliament and of the Council and Delegated Regulation (EU) 2023/905 and hereby certify that the raw milk described in Part I was produced in accordance with these requirements, and in particular that, the animals from which the raw milk has been obtained have not been administered antimicrobial medicinal products for growth promotion or yield increase or antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 as set out in Article 3 of Delegated Regulation (EU) 2023/905 and originate from a third country or region thereof listed in the Annex to Commission Implementing Regulation (EU) 2024/2598.] ⁽¹⁾ [II.2. Animal health attestation (Delete when the raw milk is derived from solipeds, leporidae or wild land mammals other than ungulates) The raw milk described in Part I: ⁽¹⁾ either [II.2.1. originates from the zone with code … ⁽²⁾ which, at the date of issue of this animal health/official certificate is authorised for the entry into the Union of milk and listed in Part 1 of Annex XVII to Commission Implementing Regulation (EU) 2021/404, and in which foot and mouth disease and infection with rinderpest virus have not been reported for the last 12 months prior to the date of milking, and vaccination against these diseases has not been carried out during that period;] ^{(1) (3)} or [II.2.1. originates from the zone with code … ⁽⁴⁾ which, at the date of issue of this animal health/official certificate is authorised for the transit through the Union of milk intended for a destination outside the Union and is listed in Part 1 of Annex XXII to Commission Implementing Regulation (EU) 2021/404;] II.2.2. has been obtained from animals of the species [Bos taurus,] ⁽¹⁾ [Ovis aries,] ⁽¹⁾ [Capra hircus,] ⁽¹⁾ [Bubalus bubalis,] ⁽¹⁾ [Camelus dromedarius] ⁽¹⁾ that: ⁽¹⁾ either [have remained in the zone referred to under point II.2.1 since birth, or for at least 3 months prior to the date of milking;] ⁽¹⁾ and/or [were introduced in the zone referred to under point II.2.1 from: ⁽¹⁾ either [another third country or territory, or zone thereof which is listed for entry into the Union of milk, colostrum or colostrum-based products, and the animals remained there for at least 3 months prior to the date of milking;]] ⁽¹⁾ and/or [Member States;]] II.2.3. has been obtained from animals coming from establishments: (a) which are registered by and are under the control of the competent authority of the third country or territory and have a system in place to maintain and to keep records in accordance with Article 8 of Commission Delegated Regulation (EU) 2020/692; (b) which receive 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 listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases; (c) which were not subject to national restriction measures for animal health reasons, including the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases, at the date of milking.] 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 Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 of 24 March 2023, OJ L 102, 17.4.2023, p. 87) in conjunction with Annex 2 to that Framework, references to the Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for the entry into the Union of raw milk, including when the Union is not the final destination of such milk. 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 Commission Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8 : Provide the code of the zone as appearing in column 2 of the table in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404. Box reference I.11 : Name, address and approval number of the establishment of dispatch. Box reference I.15 : Registration number (railway wagons or container and road vehicle), flight number (aircraft) or name (vessel) shall be provided. In the case of unloading and reloading, the consignor shall inform the border control post of entry into the Union. Box reference I.19 : For the containers or boxes, the container number and the seal number (if applicable) shall be included. Box reference I.27 : “CN code”: Indicate the appropriate Harmonised System (HS) code(s) of the World Customs Organisation under the following headings: 0401 , 0402 or 0403 . “Manufacturing plant”: Introduce the approval number of the production holding(s), collection centre or standardization centre approved for the entry into the Union. Part II: ⁽¹⁾ Delete if not applicable. ⁽²⁾ Code of the zone in accordance with column 2 of the table in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404. ⁽³⁾ Only applicable to consignments transiting through the Union and intended for a destination outside the Union, originating from third country or territory, or zone thereof listed in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404 as authorised for transit through the Union of milk accompanied by an animal health certificate corresponding to the present model certificate in accordance with column 5 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁴⁾ Code of the zone in accordance with column 2 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁵⁾ To be signed by: (a) an official veterinarian when Part II.2 Animal health attestation is not deleted, (b) a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. ⁽⁶⁾ Applicable to consignments entering the Union as from 3 September 2026.


[Official veterinarian] ^{(1) (5)}/[Certifying officer] ^{(1) (5)}	[Official veterinarian] ^{(1) (5)}/[Certifying officer] ^{(1) (5)}	[Official veterinarian] ^{(1) (5)}/[Certifying officer] ^{(1) (5)}	[Official veterinarian] ^{(1) (5)}/[Certifying officer] ^{(1) (5)}
Name (in capital letters)
Date		Qualification and title
Stamp		Signature

CHAPTER 34 MODEL ANIMAL HEALTH/OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF DAIRY PRODUCTS INTENDED FOR HUMAN CONSUMPTION DERIVED FROM RAW MILK OR DAIRY PRODUCTS THEREFROM, OR BOTH, THAT ARE NOT REQUIRED TO UNDERGO A SPECIFIC RISK-MITIGATING TREATMENT (MODEL MILK-RMP/NT)

Part I: Description of consignment


COUNTRY	Animal health/official certificate to the EU

---	---
I.1	Consignor/Exporter
	Name
	Address
	Address
	Country
I.5	Consignee/Importer
	Name
	Address
	Country
I.7	Country of origin
I.8	Region of origin
I.11	Place of dispatch
	Name
	Address
	Country
I.13	Place of loading

---	---
I.15	Means of transport
	☐ Aircraft
	☐ Railway
	Identification
	Identification

---	---
I.18	Transport conditions
I.19	Container number/Seal number
	Container No
I.20	Certified as or for
	☐ Products for human consumption

---	---
I.21	☐ For transit
	Third country

---	---
I.24	Total number of packages

---	---
I.27	Description of consignment
CN code	Species





☐ Final consumer

Part II: Certification


COUNTRY	COUNTRY	Certificate model MILK-RMP/NT	Certificate model MILK-RMP/NT	Certificate model MILK-RMP/NT	Certificate model MILK-RMP/NT
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference


⁽¹⁾ [II.1. Public health attestation (Delete when the Union is not the final destination of the dairy products) 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, Regulation (EC) No 852/2004 of the European Parliament and of the Council, Regulation (EC) No 853/2004 of the European Parliament and of the Council and Regulation (EU) 2017/625 of the European Parliament and of the Council and Commission Implementing Regulation (EU) 2019/627 and hereby certify that the dairy products described in Part I were produced in accordance with these requirements, and in particular that: (a) they were produced from raw milk: (i) which comes from holdings registered in accordance with Regulation (EC) No 852/2004 and checked in accordance with Articles 49 and 50 of Implementing Regulation (EU) 2019/627; (ii) which was produced, collected, cooled, stored and transported in accordance with the hygiene conditions laid down in Section IX, Chapter I, of Annex III to Regulation (EC) No 853/2004; (iii) which meets the plate and somatic cell count criteria laid down in Section IX, Chapter I, of Annex III to Regulation (EC) No 853/2004; (iv) which comes from animals belonging to herds officially free of tuberculosis and free or officially free of brucellosis; (v) which complies with the guarantees covering animals and products thereof provided by the control plan submitted in accordance with Article 6(2) of Commission Delegated Regulation (EU) 2022/2292 and the third country or region thereof of its origin is listed in Annex -I to Commission Implementing Regulation (EU) 2021/405 and marked with an “X” for the category “milk”; (vi) which, pursuant to testing for antibiotic residues carried out by the food business operator in accordance with the requirements of Section IX, Chapter I, Part III, point 4, of Annex III, to Regulation (EC) No 853/2004, complies with the maximum residue limits for residues of antibacterial veterinary medicinal products laid down in the Annex to Commission Regulation (EU) No 37/2010; (b) they come from establishments 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 listed as Union approved establishments; (c) they have been obtained from raw milk that has not undergone any heat treatment or any physical or chemical treatment during the manufacturing process, that would mitigate specific risks, including pasteurisation; (d) they have been wrapped, packaged and labelled in accordance with Section IX, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) they meet the relevant microbiological criteria laid down in Commission Regulation (EC) No 2073/2005.] ^{(1) (6)} [II.1a. Attestation as regards Commission Delegated Regulation (EU) 2023/905 (Delete when the Union is not the final destination of the dairy products) I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EU) 2019/6 of the European Parliament and of the Council and Delegated Regulation (EU) 2023/905 and hereby certify that the dairy products described in Part I were produced in accordance with these requirements, and in particular that, the animals from which the raw milk has been obtained have not been administered antimicrobial medicinal products for growth promotion or yield increase or antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 as set out in Article 3 of Delegated Regulation (EU) 2023/905 and originate from a third country or region thereof listed in the Annex to Commission Implementing Regulation (EU) 2024/2598.] ⁽¹⁾ [II.2. Animal health attestation (Delete when the dairy products are derived from solipeds, leporidae or wild land mammals other than ungulates) The dairy products described in Part I: ⁽¹⁾ either [II.2.1. originate from the zone with code … ⁽²⁾ which, at the date of issue of this animal health/official certificate is authorised for the entry into the Union of milk and listed in Part 1 of Annex XVII to Commission Implementing Regulation (EU) 2021/404, and in which foot and mouth disease and infection with rinderpest virus have not been reported for the last 12 months prior to the date of milking, and during that period vaccination against these diseases has not been carried out;] ^{(1) (3)} or [II.2.1. originate from the zone with code … ⁽⁴⁾ which, at the date of issue of this animal health/official certificate is authorised for the transit through the Union of milk intended for a destination outside the Union and is listed in Part 1 of Annex XXII to Commission Implementing Regulation (EU) 2021/404;] II.2.2. have been processed from: ⁽¹⁾ either [II.2.2.1 raw milk originating from: ⁽¹⁾ either [the zone referred to in point II.2.1 and obtained from animals of the species [Bos taurus,] ⁽¹⁾ [Ovis aries,] ⁽¹⁾ [Capra hircus,] ⁽¹⁾ [Bubalus bubalis,] ⁽¹⁾ [Camelus dromedarius] ⁽¹⁾ that: ⁽¹⁾ either [(a) have remained in the zone referred to under point II.2.1 since birth, or for the last 3 months prior to the date of milking;] ⁽¹⁾ and/or [(a) were introduced in the zone referred to under point II.2.1 from: ⁽¹⁾ either [another third country or territory, or zone thereof which is listed for entry into the Union of milk, colostrum or colostrum-based products, and the animals remained there for the last 3 months prior to the date of milking;]] ⁽¹⁾ and/or [Member States;]] (b) have been kept in establishments: (i) which are registered by and are under the control of the competent authority of the third country or territory and have a system in place to maintain and to keep records in accordance with Article 8 of Commission Delegated Regulation (EU) 2020/692; (ii) which receive 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 listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases; (iii) which were not subject to national restriction measures for animal health reasons, including the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases, at the date of milking;]]] ⁽¹⁾ and/or [the zone(s) with code(s) … ⁽²⁾ which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of milk and listed in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404, and that raw milk complied with all the relevant requirements for the entry into the Union of raw milk laid down in Delegated Regulation (EU) 2020/692 and, therefore, was eligible for the entry into the Union as such upon arrival in the zone referred to under point II.2.1;]]] ⁽¹⁾ and/or [Member States;]]] ⁽¹⁾ and/or [II.2.2.2. dairy products: (a) produced in: ⁽¹⁾ either [the zone referred to in point II.2.1;]] ⁽¹⁾ and/or [the zone(s) with code(s) … ⁽²⁾ which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of milk and is/are listed in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404, and that raw milk complied with all the relevant requirements for the entry into the Union of raw milk laid down in Delegated Regulation (EU) 2020/692 and, therefore, was eligible for the entry into the Union as such upon arrival in the zone referred to under point II.2.1;]] ⁽¹⁾ and/or [Member States;]] (b) obtained from raw milk originating from: ⁽¹⁾ either [the zone referred to in point II.2.1 and obtained from animals of the species [Bos taurus,] ⁽¹⁾ [Ovis aries,] ⁽¹⁾ [Capra hircus,] ⁽¹⁾ [Bubalus bubalis,] ⁽¹⁾ [Camelus dromedarius] ⁽¹⁾ that: ⁽¹⁾ either [(i) have remained in the zone referred to under point II.2.1 since birth, or for the last 3 months prior to the date of milking;] ⁽¹⁾ and/or [(i) were introduced in the zone referred to under point II.2.1 from: ⁽¹⁾ either [another third country or territory, or zone thereof which is listed for entry into the Union of milk, colostrum or colostrum-based products, and the animals remained there for the last 3 months prior to the date of milking;]] ⁽¹⁾ and/or [Member States;]] (ii) have been kept in establishments: (1) which are registered by and are under the control of the competent authority of the third country or territory and have a system in place to maintain and to keep records in accordance with Article 8 of Delegated Regulation (EU) 2020/692; (2) which receive 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 listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases; (3) which were not subject to national restriction measures for animal health reasons, including the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases, at the date of milking;]]] ⁽¹⁾ and/or [the zone(s) with code(s) … ⁽²⁾ which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of milk and is/are listed in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404, and that raw milk complied with all the relevant requirements for the entry into the Union of raw milk laid down in Delegated Regulation (EU) 2020/692 and, therefore, was eligible for the entry into the Union as such upon arrival in the zone referred to under point II.2.1;]]] ⁽¹⁾ and/or [Member States.]]] 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 Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 of 24 March 2023, OJ L 102, 17.4.2023, p. 87) in conjunction with Annex 2 to that Framework, references to the Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for the entry into the Union of dairy products (as defined in point 7.2 of Annex I to Regulation (EC) No 853/2004) intended for human consumption derived from raw milk or that are not required to undergo a specific risk-mitigating treatment against foot and mouth disease in accordance with Annex XVII to Implementing Regulation (EU) 2021/404 neither a pasteurisation treatment, including when the Union is not the final destination of such dairy products. 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 Commission Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8 : Provide the code of the zone as appearing in column 2 of the table in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404. Box reference I.11 : Name, address and approval number of the establishment of dispatch. Box reference I.15 : Registration number (railway wagons or container and road vehicles), flight number (aircraft) or name (vessel) shall be provided. In the case of transport in containers, their registration number, and where there is a serial number of the seal, it shall be indicated in box I.19. In the case of unloading and reloading, the consignor shall inform the border control post of entry into the Union. Box reference I.19 : For the containers or boxes, the container number and the seal number (if applicable) shall be included. Box reference I.27 : “CN code”: Indicate the appropriate Harmonised System (HS) code(s) of the World Customs Organisation under the following headings: 0401 , 0402 , 0403 , 0404 , 0405 , 0406 , 1702 , 1806 , 2105 , 2202 99 , 3501 , 3502 or 3504 . “Manufacturing plant”: Introduce the approval number of the production holding(s), collection centre or standardization centre approved for the entry into the Union. Part II: ⁽¹⁾ Delete if not applicable. ⁽²⁾ Code of the zone in accordance with column 2 of the table in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404. ⁽³⁾ Only applicable to consignments transiting through the Union and intended for a destination outside the Union, originating from third country or territory, or zone thereof listed in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404 as authorised for transit through the Union of milk accompanied by an animal health certificate corresponding to the present model certificate in accordance with column 5 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁴⁾ Code of the zone in accordance with column 2 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁵⁾ To be signed by: (a) an official veterinarian when Part II.2 Animal health attestation is not deleted, (b) a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. ⁽⁶⁾ Applicable to consignments entering the Union as from 3 September 2026.

⁽¹⁾ [II.1. Public health attestation (Delete when the Union is not the final destination of the dairy products) 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, Regulation (EC) No 852/2004 of the European Parliament and of the Council, Regulation (EC) No 853/2004 of the European Parliament and of the Council and Regulation (EU) 2017/625 of the European Parliament and of the Council and Commission Implementing Regulation (EU) 2019/627 and hereby certify that the dairy products described in Part I were produced in accordance with these requirements, and in particular that: (a) they were produced from raw milk: (i) which comes from holdings registered in accordance with Regulation (EC) No 852/2004 and checked in accordance with Articles 49 and 50 of Implementing Regulation (EU) 2019/627; (ii) which was produced, collected, cooled, stored and transported in accordance with the hygiene conditions laid down in Section IX, Chapter I, of Annex III to Regulation (EC) No 853/2004; (iii) which meets the plate and somatic cell count criteria laid down in Section IX, Chapter I, of Annex III to Regulation (EC) No 853/2004; (iv) which comes from animals belonging to herds officially free of tuberculosis and free or officially free of brucellosis; (v) which complies with the guarantees covering animals and products thereof provided by the control plan submitted in accordance with Article 6(2) of Commission Delegated Regulation (EU) 2022/2292 and the third country or region thereof of its origin is listed in Annex -I to Commission Implementing Regulation (EU) 2021/405 and marked with an “X” for the category “milk”; (vi) which, pursuant to testing for antibiotic residues carried out by the food business operator in accordance with the requirements of Section IX, Chapter I, Part III, point 4, of Annex III, to Regulation (EC) No 853/2004, complies with the maximum residue limits for residues of antibacterial veterinary medicinal products laid down in the Annex to Commission Regulation (EU) No 37/2010; (b) they come from establishments 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 listed as Union approved establishments; (c) they have been obtained from raw milk that has not undergone any heat treatment or any physical or chemical treatment during the manufacturing process, that would mitigate specific risks, including pasteurisation; (d) they have been wrapped, packaged and labelled in accordance with Section IX, Chapters III and IV, of Annex III to Regulation (EC) No 853/2004; (e) they meet the relevant microbiological criteria laid down in Commission Regulation (EC) No 2073/2005.] ^{(1) (6)} [II.1a. Attestation as regards Commission Delegated Regulation (EU) 2023/905 (Delete when the Union is not the final destination of the dairy products) I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EU) 2019/6 of the European Parliament and of the Council and Delegated Regulation (EU) 2023/905 and hereby certify that the dairy products described in Part I were produced in accordance with these requirements, and in particular that, the animals from which the raw milk has been obtained have not been administered antimicrobial medicinal products for growth promotion or yield increase or antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 as set out in Article 3 of Delegated Regulation (EU) 2023/905 and originate from a third country or region thereof listed in the Annex to Commission Implementing Regulation (EU) 2024/2598.] ⁽¹⁾ [II.2. Animal health attestation (Delete when the dairy products are derived from solipeds, leporidae or wild land mammals other than ungulates) The dairy products described in Part I: ⁽¹⁾ either [II.2.1. originate from the zone with code … ⁽²⁾ which, at the date of issue of this animal health/official certificate is authorised for the entry into the Union of milk and listed in Part 1 of Annex XVII to Commission Implementing Regulation (EU) 2021/404, and in which foot and mouth disease and infection with rinderpest virus have not been reported for the last 12 months prior to the date of milking, and during that period vaccination against these diseases has not been carried out;] ^{(1) (3)} or [II.2.1. originate from the zone with code … ⁽⁴⁾ which, at the date of issue of this animal health/official certificate is authorised for the transit through the Union of milk intended for a destination outside the Union and is listed in Part 1 of Annex XXII to Commission Implementing Regulation (EU) 2021/404;] II.2.2. have been processed from: ⁽¹⁾ either [II.2.2.1 raw milk originating from: ⁽¹⁾ either [the zone referred to in point II.2.1 and obtained from animals of the species [Bos taurus,] ⁽¹⁾ [Ovis aries,] ⁽¹⁾ [Capra hircus,] ⁽¹⁾ [Bubalus bubalis,] ⁽¹⁾ [Camelus dromedarius] ⁽¹⁾ that: ⁽¹⁾ either [(a) have remained in the zone referred to under point II.2.1 since birth, or for the last 3 months prior to the date of milking;] ⁽¹⁾ and/or [(a) were introduced in the zone referred to under point II.2.1 from: ⁽¹⁾ either [another third country or territory, or zone thereof which is listed for entry into the Union of milk, colostrum or colostrum-based products, and the animals remained there for the last 3 months prior to the date of milking;]] ⁽¹⁾ and/or [Member States;]] (b) have been kept in establishments: (i) which are registered by and are under the control of the competent authority of the third country or territory and have a system in place to maintain and to keep records in accordance with Article 8 of Commission Delegated Regulation (EU) 2020/692; (ii) which receive 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 listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases; (iii) which were not subject to national restriction measures for animal health reasons, including the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases, at the date of milking;]]] ⁽¹⁾ and/or [the zone(s) with code(s) … ⁽²⁾ which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of milk and listed in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404, and that raw milk complied with all the relevant requirements for the entry into the Union of raw milk laid down in Delegated Regulation (EU) 2020/692 and, therefore, was eligible for the entry into the Union as such upon arrival in the zone referred to under point II.2.1;]]] ⁽¹⁾ and/or [Member States;]]] ⁽¹⁾ and/or [II.2.2.2. dairy products: (a) produced in: ⁽¹⁾ either [the zone referred to in point II.2.1;]] ⁽¹⁾ and/or [the zone(s) with code(s) … ⁽²⁾ which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of milk and is/are listed in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404, and that raw milk complied with all the relevant requirements for the entry into the Union of raw milk laid down in Delegated Regulation (EU) 2020/692 and, therefore, was eligible for the entry into the Union as such upon arrival in the zone referred to under point II.2.1;]] ⁽¹⁾ and/or [Member States;]] (b) obtained from raw milk originating from: ⁽¹⁾ either [the zone referred to in point II.2.1 and obtained from animals of the species [Bos taurus,] ⁽¹⁾ [Ovis aries,] ⁽¹⁾ [Capra hircus,] ⁽¹⁾ [Bubalus bubalis,] ⁽¹⁾ [Camelus dromedarius] ⁽¹⁾ that: ⁽¹⁾ either [(i) have remained in the zone referred to under point II.2.1 since birth, or for the last 3 months prior to the date of milking;] ⁽¹⁾ and/or [(i) were introduced in the zone referred to under point II.2.1 from: ⁽¹⁾ either [another third country or territory, or zone thereof which is listed for entry into the Union of milk, colostrum or colostrum-based products, and the animals remained there for the last 3 months prior to the date of milking;]] ⁽¹⁾ and/or [Member States;]] (ii) have been kept in establishments: (1) which are registered by and are under the control of the competent authority of the third country or territory and have a system in place to maintain and to keep records in accordance with Article 8 of Delegated Regulation (EU) 2020/692; (2) which receive 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 listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases; (3) which were not subject to national restriction measures for animal health reasons, including the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for the species and emerging diseases, at the date of milking;]]] ⁽¹⁾ and/or [the zone(s) with code(s) … ⁽²⁾ which, at the date of issue of this animal health/official certificate is/are authorised for the entry into the Union of milk and is/are listed in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404, and that raw milk complied with all the relevant requirements for the entry into the Union of raw milk laid down in Delegated Regulation (EU) 2020/692 and, therefore, was eligible for the entry into the Union as such upon arrival in the zone referred to under point II.2.1;]]] ⁽¹⁾ and/or [Member States.]]] 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 Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 of 24 March 2023, OJ L 102, 17.4.2023, p. 87) in conjunction with Annex 2 to that Framework, references to the Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland. This animal health/official certificate is intended for the entry into the Union of dairy products (as defined in point 7.2 of Annex I to Regulation (EC) No 853/2004) intended for human consumption derived from raw milk or that are not required to undergo a specific risk-mitigating treatment against foot and mouth disease in accordance with Annex XVII to Implementing Regulation (EU) 2021/404 neither a pasteurisation treatment, including when the Union is not the final destination of such dairy products. 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 Commission Implementing Regulation (EU) 2020/2235. Part I: Box reference I.8 : Provide the code of the zone as appearing in column 2 of the table in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404. Box reference I.11 : Name, address and approval number of the establishment of dispatch. Box reference I.15 : Registration number (railway wagons or container and road vehicles), flight number (aircraft) or name (vessel) shall be provided. In the case of transport in containers, their registration number, and where there is a serial number of the seal, it shall be indicated in box I.19. In the case of unloading and reloading, the consignor shall inform the border control post of entry into the Union. Box reference I.19 : For the containers or boxes, the container number and the seal number (if applicable) shall be included. Box reference I.27 : “CN code”: Indicate the appropriate Harmonised System (HS) code(s) of the World Customs Organisation under the following headings: 0401 , 0402 , 0403 , 0404 , 0405 , 0406 , 1702 , 1806 , 2105 , 2202 99 , 3501 , 3502 or 3504 . “Manufacturing plant”: Introduce the approval number of the production holding(s), collection centre or standardization centre approved for the entry into the Union. Part II: ⁽¹⁾ Delete if not applicable. ⁽²⁾ Code of the zone in accordance with column 2 of the table in Part 1 of Annex XVII to Implementing Regulation (EU) 2021/404. ⁽³⁾ Only applicable to consignments transiting through the Union and intended for a destination outside the Union, originating from third country or territory, or zone thereof listed in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404 as authorised for transit through the Union of milk accompanied by an animal health certificate corresponding to the present model certificate in accordance with column 5 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁴⁾ Code of the zone in accordance with column 2 of the table in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404. ⁽⁵⁾ To be signed by: (a) an official veterinarian when Part II.2 Animal health attestation is not deleted, (b) a certifying officer or an official veterinarian when Part II.2 Animal health attestation is deleted. ⁽⁶⁾ Applicable to consignments entering the Union as from 3 September 2026.


[Official veterinarian] ^{(1) (5)}/[Certifying officer] ^{(1) (5)}	[Official veterinarian] ^{(1) (5)}/[Certifying officer] ^{(1) (5)}	[Official veterinarian] ^{(1) (5)}/[Certifying officer] ^{(1) (5)}	[Official veterinarian] ^{(1) (5)}/[Certifying officer] ^{(1) (5)}
Name (in capital letters)
Date		Qualification and title
Stamp		Signature

CHAPTER 35 MODEL ANIMAL HEALTH/OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF DAIRY PRODUCTS INTENDED FOR HUMAN CONSUMPTION THAT ARE REQUIRED TO UNDERGO A PASTEURISATION TREATMENT (MODEL DAIRY-PRODUCTS-PT)

Part I: Description of consignment


COUNTRY	Animal health/official certificate to the EU

---	---
I.1	Consignor/Exporter
	Name
	Address
	Address
	Country
I.5	Consignee/Importer
	Name
	Address
	Country
I.7	Country of origin
I.8	Region of origin
I.11	Place of dispatch
	Name
	Address
	Country
I.13	Place of loading

---	---
I.15	Means of transport
	☐ Aircraft
	☐ Railway
	Identification
	Identification

---	---
I.18	Transport conditions
I.19	Container number/Seal number
	Container No
I.20	Certified as or for
	☐ Products for human consumption

---	---
I.21	☐ For transit
	Third country

---	---
I.24	Total number of packages

---	---
I.27	Description of consignment
CN code	Species





☐ Final consumer

Part II: Certification


COUNTRY	COUNTRY	Certificate model DAIRY-PRODUCTS-PT	Certificate model DAIRY-PRODUCTS-PT	Certificate model DAIRY-PRODUCTS-PT	Certificate model DAIRY-PRODUCTS-PT
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference

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