Legalize / European Union / Implementing Regulation

Commission Implementing Regulation (EU) 2025/544 of 25 March 2025 amending Implementing Regulation (EU) 2021/403 as regards model animal health certificates and model animal health/official certificates for the entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof

Type Implementing Regulation

Publication 2025-04-22

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

articles 3

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

Reform history JSON API


COUNTRY	Animal health certificate to the EU

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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

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


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

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

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

Part II: Certification


COUNTRY	COUNTRY	Certificate model BOV-OOCYTES-EMB-A-ENTRY	Certificate model BOV-OOCYTES-EMB-A-ENTRY	Certificate model BOV-OOCYTES-EMB-A-ENTRY	Certificate model BOV-OOCYTES-EMB-A-ENTRY
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference


I, the undersigned official veterinarian, hereby certify that: II.1. The [oocytes] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ of the consignment described in Part I are intended for artificial reproduction and were obtained from donor animals which originate from a third country or territory, or zone thereof: II.1.1. authorised for the entry into the Union of [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ of bovine animals and listed in Annex IX to Commission Implementing Regulation (EU) 2021/404; ⁽¹⁾ either [II.1.2. where foot and mouth disease was not reported for at least 24 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch;] ^{(1) (2)} or [II.1.2. where foot and mouth disease was not reported for a period starting on the date //____ (dd/mm/yyyy) immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch;] II.1.3. where infection with rinderpest virus, infection with Rift Valley fever virus, contagious bovine pleuropneumonia and lumpy skin disease were not reported for at least 12 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch; II.1.4. where no vaccination against infection with rinderpest virus, infection with Rift Valley fever virus and contagious bovine pleuropneumonia has been carried out for at least 12 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾, and until the date of their dispatch, and no vaccinated animals entered into the third country or territory, or zone thereof during that period, and ⁽¹⁾ either [no vaccination against foot and mouth disease has been carried out for the same period, and no vaccinated animals entered into the third country or territory, or zone thereof during that period.] ⁽¹⁾ or [vaccination against foot and mouth disease has been carried out for the same period, or vaccinated animals entered into the third country or territory, or zone thereof during that period.] ⁽¹⁾ [II.2. The [oocytes] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ of the consignment described in Part I have been collected, processed and stored, and dispatched by the embryo collection team ⁽³⁾ which: II.2.1. is approved and listed by the competent authority of the third country or territory; II.2.2. complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Part 2 of Annex I to Commission Delegated Regulation (EU) 2020/686.] ⁽¹⁾ [II.2. The [oocytes] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ of the consignment described in Part I have been collected or produced, processed and stored, and dispatched by the embryo production team ⁽³⁾ which: II.2.1. is approved and listed by the competent authority of the third country or territory; II.2.2. complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Parts 2 and 3 of Annex I to Delegated Regulation (EU) 2020/686.] II.3. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ of the consignment described in Part I were obtained from donor animals which originate from establishments: II.3.1. free from infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis), and they have never been kept previously in any establishment of a lower health status; II.3.2. free from infection with Brucella abortus, B. melitensis and B. suis and they have never been kept previously in any establishment of a lower health status; ⁽¹⁾ either [II.3.3. free from enzootic bovine leukosis and they have never been kept previously in any establishment of a lower health status;] ⁽¹⁾ or [II.3.3. not free from enzootic bovine leukosis and the official veterinarian responsible for the establishment of origin has certified that there has been no clinical case of enzootic bovine leukosis during at least the preceding 3 years prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and during the collection period;] ⁽¹⁾ either [II.3.4. free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis and they have never been kept previously in any establishment of a lower health status;] ⁽¹⁾ or [II.3.4. not free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis and the official veterinarian responsible for the establishment of origin has certified that there has been no clinical case of infectious bovine rhinotracheitis/infectious pustular vulvovaginitis during at least the preceding 12 months prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and during the collection period;] II.3.5. in which ⁽¹⁾ either [surra (Trypanosoma evansi) has not been reported during the last 2 years prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾.] ⁽¹⁾ or [surra (Trypanosoma evansi) has not been reported during the preceding 30 days prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾, and when the disease was reported in the establishments during the preceding 2 years prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾, following the last outbreak, the establishments have remained under movement restrictions until the date on which the infected animals have been removed from the establishments, and the remaining animals in the establishments have been subjected to a test for surra with one of the diagnostic methods provided for in Part 3 of Annex I to Commission Delegated Regulation (EU) 2020/688, carried out, with negative results, on samples taken at least 6 months after the date on which the infected animals have been removed from the establishments.] II.4. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ of the consignment described in Part I were obtained from donor animals which: II.4.1. were not vaccinated against infection with rinderpest virus, infection with Rift Valley fever virus, contagious bovine pleuropneumonia and lumpy skin disease; II.4.2. remained for at least the preceding 6 months prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ in a third country or territory, or zone thereof referred to in box I.7; II.4.3. for at least the preceding 30 days prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and during the collection period: II.4.3.1. were kept in establishments not situated in a restricted zone established due to the occurrence of foot and mouth disease, infection with rinderpest virus, infection with Rift Valley fever virus, contagious bovine pleuropneumonia or lumpy skin disease, or of an emerging disease relevant for bovine animals; II.4.3.2. were kept in a single establishment where infection with Brucella abortus, B. melitensis and B. suis, infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis), rabies, anthrax, surra (Trypanosoma evansi), enzootic bovine leukosis, infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, bovine viral diarrhoea, infection with epizootic haemorrhagic disease virus and infection with bluetongue virus (serotypes 1-24) have not been reported; II.4.3.3. were not in contact with animals from establishments situated in a restricted zone due to the occurrence of diseases referred to in point II.4.3.1 or from establishments which do not meet the conditions referred to in point II.4.3.2; II.4.3.4. were not used for natural breeding; II.4.4. were examined by the team veterinarian or a team member and did not show symptoms or clinical signs of transmissible animal diseases on the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; II.4.5. are individually identified as provided for in Article 21(1) of Delegated Regulation (EU) 2020/692; II.4.6. comply with the following conditions as regards foot and mouth disease: II.4.6.1. they come from establishments: (a) situated in an area where foot and mouth disease has not been reported within a 10-km radius centred on the establishments for at least 30 days immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; (b) in which foot and mouth disease has not been reported during at least 3 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; ⁽¹⁾ either [II.4.6.2. they were not vaccinated against foot and mouth disease;] ^{(1) (4)} or [II.4.6.2. they were vaccinated against foot and mouth disease during the last 12 months prior to the date of collection of the embryos, and: II.4.6.2.1. have not been vaccinated against foot and mouth disease within at least 30 days immediately prior to the date of collection of the embryos; II.4.6.2.2. the semen used for fertilisation was collected from a male donor that complies with the conditions set out in Part 5, Chapter I, point 1(b), of Annex II to Delegated Regulation (EU) 2020/686 or the semen complies with the conditions set out in Part 5, Chapter I, point 2, of Annex II to Delegated Regulation (EU) 2020/686; II.4.6.2.3. prior to the date of freezing, the embryos have been subjected to trypsin washing carried out in accordance with the recommendations of the IETS Manual ⁽⁵⁾; II.4.6.2.4. the embryos were stored deep frozen for at least 30 days from the date of collection, and during that period the donor animal has not shown clinical signs of foot and mouth disease;] ^{(1) (6)} [II.4.7. comply with at least one of the following conditions as regards infection with bluetongue virus (serotypes 1-24): ⁽¹⁾ either [II.4.7.1. they have been kept for at least 60 days prior to the date of and during collection of the oocytes in a third country or territory, zone thereof free from infection with bluetongue virus (serotypes 1-24) where no case of infection with bluetongue virus (serotypes 1-24) has been confirmed in the targeted animal population during the last 24 months;] ^{(1) (12)} or [II.4.7.2. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to and during collection of the oocytes;] ⁽¹⁾ and/or [II.4.7.3. they have been kept in a vector-protected establishment for at least 60 days prior to the date of and during collection of the oocytes;] ⁽¹⁾ and/or [II.4.7.4. they have been subjected to a serological test able to detect specific antibodies against all serotypes (1-24) of bluetongue virus, with negative results, between 28 and 60 days from the date of each collection of the oocytes;] ⁽¹⁾ and/or [II.4.7.5. they have been subjected to an agent identification test for bluetongue virus (serotypes 1-24), with negative results, on a blood sample taken on the date of collection of the oocytes;]] II.4.8. comply with at least one of the following conditions as regards infection with epizootic haemorrhagic disease virus (EHDV): ⁽¹⁾ either [II.4.8.1. they have been kept for at least 60 days prior to the date of and during collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾ in a third country or territory, or zone thereof where EHDV has not been reported for at least the preceding 2 years within a radius of 150 km of the establishments;] ^{(1) (13)} or [II.4.8.2. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to the date of and during collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾;] ⁽¹⁾ and/or [II.4.8.3. they have been kept in a vector-protected establishment for at least 60 days prior to the date of and during collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾;] ⁽¹⁾ or [II.4.8.4. were resident in the third country or territory or zone thereof of dispatch of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ of the consignment to the Union in which according to official findings the following serotypes of EHDV exist: … and have been subjected with negative results in each case to the following tests carried out in an official laboratory: ⁽¹⁾ either [II.4.8.4.1. a serological test able to detect specific antibodies against those serotypes of EHDV, with negative results, on blood samples taken between 28 and 60 days from the date of collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾;]] ⁽¹⁾ and/or [II.4.8.4.2. an agent identification test for EHDV, with negative results, on blood samples taken on the date of collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾.]] ^{(1) (6)} [II.4.9. comply with animal health requirements laid down in Part 1, Chapter III, of Annex II to Delegated Regulation (EU) 2020/686;] II.5. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I: II.5.1. have been collected, processed and stored in accordance with animal health requirements set out in [Part 2] ⁽¹⁾[Part 3] ⁽¹⁾ [Part 4] ⁽¹⁾ [Part 5] ⁽¹⁾and Part 6 of Annex III to Delegated Regulation (EU) 2020/686; II.5.2. are placed in straws or other packages on which the mark is applied in accordance with requirements provided for in Article 83, point (a), of Delegated Regulation (EU) 2020/692 and that mark is indicated in box I.27; II.5.3. are transported in a container which: II.5.3.1. was sealed and numbered prior to the date of dispatch to the Union by the embryo collection or production team under responsibility of the team veterinarian, or by an official veterinarian, and the seal bears the number as indicated in box I.19; II.5.3.2. has been cleaned and either disinfected or sterilised before use, or is single-use container; ^{(1) (7)} [II.5.3.3. has been filled in with a cryogenic agent which has not been previously used for other products;] ^{(1) (8)} [II.5.4. are placed in straws or other packages which are securely and hermetically sealed; II.5.5. are transported in a container where the different types are separated from each other by physical compartments or by being placed in secondary protective bags.] ^{(1) (9)} [II.6. The [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ of the consignment described in Part I were conceived by artificial insemination using semen coming from a semen collection centre, germinal product processing establishment or germinal product storage centre approved for the collection, processing and storage of semen by the competent authority of a third country or territory, or zone thereof listed in Annex IX to Implementing Regulation (EU) 2021/404 for semen of bovine animals or by the competent authority of a Member State, and were collected, processed and stored in accordance with the requirements of Part 1, Chapter I and Part 5, Chapters II and III, of Annex II, and Part 1 of Annex III to Delegated Regulation (EU) 2020/686.] ^{(1) (10)} [II.7. The following antibiotic or mixture of antibiotics ⁽¹¹⁾ has been added to the collection, processing, washing or storage media: … .] 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 certificate include the United Kingdom in respect of Northern Ireland. This animal health 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.11 : “Place of dispatch”: Indicate the unique approval number and the name and address of the embryo collection or production team of dispatch of the consignment of oocytes or embryos. Only embryo collection or production teams listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of oocytes or embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Species”: Select amongst “ Bos taurus ”, “ Bison bison ” or “ Bubalus bubalis ” as appropriate. “Type”: Specify if oocytes, in vivo derived embryos, in vitro produced embryos or micromanipulated embryos. “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where oocytes or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which oocytes or embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo collection or production team by which the oocytes or embryos of the consignment were collected or produced. “Quantity”: Indicate the number of straws or other packages with the same mark. “Test”: For BTV-test, indicate: “point II.4.7.4” or “point II.4.7.5”, or both; for EHD-test, indicate: “point II.4.8.4.1” or “point II.4.8.4.2”, or both, if relevant. Part II: ⁽¹⁾ Delete if not applicable. ⁽²⁾ Only for a third country or territory, or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404. ⁽³⁾ Only embryo collection or production teams listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. ⁽⁴⁾ Option available only for the consignment of in vivo derived embryos. ⁽⁵⁾ Manual of the International Embryo Technology Society — A procedural guide and general information for the use of embryo transfer technology emphasising sanitary procedures, published by the International Embryo Technology Society, 1 111 North Dunlap Avenue, Savoy, Illinois 61 874, USA (http://www.iets.org/). ⁽⁶⁾ Applicable for the consignment of oocytes and in vitro produced embryos. ⁽⁷⁾ Applicable for frozen oocytes or embryos. ⁽⁸⁾ Applicable for consignments where oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of bovine animals are placed and transported in one container. ⁽⁹⁾ Does not apply to oocytes. ⁽¹⁰⁾ Mandatory attestation in case antibiotics were added. ⁽¹¹⁾ Insert the name(s) of the antibiotic(s) added and its (their) concentration. ⁽¹²⁾ For the zones with an entry “SF-BTV” in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404. ⁽¹³⁾ For the zones with an entry “SF-EHD” in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.

I, the undersigned official veterinarian, hereby certify that: II.1. The [oocytes] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ of the consignment described in Part I are intended for artificial reproduction and were obtained from donor animals which originate from a third country or territory, or zone thereof: II.1.1. authorised for the entry into the Union of [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ of bovine animals and listed in Annex IX to Commission Implementing Regulation (EU) 2021/404; ⁽¹⁾ either [II.1.2. where foot and mouth disease was not reported for at least 24 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch;] ^{(1) (2)} or [II.1.2. where foot and mouth disease was not reported for a period starting on the date //____ (dd/mm/yyyy) immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch;] II.1.3. where infection with rinderpest virus, infection with Rift Valley fever virus, contagious bovine pleuropneumonia and lumpy skin disease were not reported for at least 12 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch; II.1.4. where no vaccination against infection with rinderpest virus, infection with Rift Valley fever virus and contagious bovine pleuropneumonia has been carried out for at least 12 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾, and until the date of their dispatch, and no vaccinated animals entered into the third country or territory, or zone thereof during that period, and ⁽¹⁾ either [no vaccination against foot and mouth disease has been carried out for the same period, and no vaccinated animals entered into the third country or territory, or zone thereof during that period.] ⁽¹⁾ or [vaccination against foot and mouth disease has been carried out for the same period, or vaccinated animals entered into the third country or territory, or zone thereof during that period.] ⁽¹⁾ [II.2. The [oocytes] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ of the consignment described in Part I have been collected, processed and stored, and dispatched by the embryo collection team ⁽³⁾ which: II.2.1. is approved and listed by the competent authority of the third country or territory; II.2.2. complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Part 2 of Annex I to Commission Delegated Regulation (EU) 2020/686.] ⁽¹⁾ [II.2. The [oocytes] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ of the consignment described in Part I have been collected or produced, processed and stored, and dispatched by the embryo production team ⁽³⁾ which: II.2.1. is approved and listed by the competent authority of the third country or territory; II.2.2. complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Parts 2 and 3 of Annex I to Delegated Regulation (EU) 2020/686.] II.3. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ of the consignment described in Part I were obtained from donor animals which originate from establishments: II.3.1. free from infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis), and they have never been kept previously in any establishment of a lower health status; II.3.2. free from infection with Brucella abortus, B. melitensis and B. suis and they have never been kept previously in any establishment of a lower health status; ⁽¹⁾ either [II.3.3. free from enzootic bovine leukosis and they have never been kept previously in any establishment of a lower health status;] ⁽¹⁾ or [II.3.3. not free from enzootic bovine leukosis and the official veterinarian responsible for the establishment of origin has certified that there has been no clinical case of enzootic bovine leukosis during at least the preceding 3 years prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and during the collection period;] ⁽¹⁾ either [II.3.4. free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis and they have never been kept previously in any establishment of a lower health status;] ⁽¹⁾ or [II.3.4. not free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis and the official veterinarian responsible for the establishment of origin has certified that there has been no clinical case of infectious bovine rhinotracheitis/infectious pustular vulvovaginitis during at least the preceding 12 months prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and during the collection period;] II.3.5. in which ⁽¹⁾ either [surra (Trypanosoma evansi) has not been reported during the last 2 years prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾.] ⁽¹⁾ or [surra (Trypanosoma evansi) has not been reported during the preceding 30 days prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾, and when the disease was reported in the establishments during the preceding 2 years prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾, following the last outbreak, the establishments have remained under movement restrictions until the date on which the infected animals have been removed from the establishments, and the remaining animals in the establishments have been subjected to a test for surra with one of the diagnostic methods provided for in Part 3 of Annex I to Commission Delegated Regulation (EU) 2020/688, carried out, with negative results, on samples taken at least 6 months after the date on which the infected animals have been removed from the establishments.] II.4. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ of the consignment described in Part I were obtained from donor animals which: II.4.1. were not vaccinated against infection with rinderpest virus, infection with Rift Valley fever virus, contagious bovine pleuropneumonia and lumpy skin disease; II.4.2. remained for at least the preceding 6 months prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ in a third country or territory, or zone thereof referred to in box I.7; II.4.3. for at least the preceding 30 days prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and during the collection period: II.4.3.1. were kept in establishments not situated in a restricted zone established due to the occurrence of foot and mouth disease, infection with rinderpest virus, infection with Rift Valley fever virus, contagious bovine pleuropneumonia or lumpy skin disease, or of an emerging disease relevant for bovine animals; II.4.3.2. were kept in a single establishment where infection with Brucella abortus, B. melitensis and B. suis, infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis), rabies, anthrax, surra (Trypanosoma evansi), enzootic bovine leukosis, infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, bovine viral diarrhoea, infection with epizootic haemorrhagic disease virus and infection with bluetongue virus (serotypes 1-24) have not been reported; II.4.3.3. were not in contact with animals from establishments situated in a restricted zone due to the occurrence of diseases referred to in point II.4.3.1 or from establishments which do not meet the conditions referred to in point II.4.3.2; II.4.3.4. were not used for natural breeding; II.4.4. were examined by the team veterinarian or a team member and did not show symptoms or clinical signs of transmissible animal diseases on the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; II.4.5. are individually identified as provided for in Article 21(1) of Delegated Regulation (EU) 2020/692; II.4.6. comply with the following conditions as regards foot and mouth disease: II.4.6.1. they come from establishments: (a) situated in an area where foot and mouth disease has not been reported within a 10-km radius centred on the establishments for at least 30 days immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; (b) in which foot and mouth disease has not been reported during at least 3 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; ⁽¹⁾ either [II.4.6.2. they were not vaccinated against foot and mouth disease;] ^{(1) (4)} or [II.4.6.2. they were vaccinated against foot and mouth disease during the last 12 months prior to the date of collection of the embryos, and: II.4.6.2.1. have not been vaccinated against foot and mouth disease within at least 30 days immediately prior to the date of collection of the embryos; II.4.6.2.2. the semen used for fertilisation was collected from a male donor that complies with the conditions set out in Part 5, Chapter I, point 1(b), of Annex II to Delegated Regulation (EU) 2020/686 or the semen complies with the conditions set out in Part 5, Chapter I, point 2, of Annex II to Delegated Regulation (EU) 2020/686; II.4.6.2.3. prior to the date of freezing, the embryos have been subjected to trypsin washing carried out in accordance with the recommendations of the IETS Manual ⁽⁵⁾; II.4.6.2.4. the embryos were stored deep frozen for at least 30 days from the date of collection, and during that period the donor animal has not shown clinical signs of foot and mouth disease;] ^{(1) (6)} [II.4.7. comply with at least one of the following conditions as regards infection with bluetongue virus (serotypes 1-24): ⁽¹⁾ either [II.4.7.1. they have been kept for at least 60 days prior to the date of and during collection of the oocytes in a third country or territory, zone thereof free from infection with bluetongue virus (serotypes 1-24) where no case of infection with bluetongue virus (serotypes 1-24) has been confirmed in the targeted animal population during the last 24 months;] ^{(1) (12)} or [II.4.7.2. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to and during collection of the oocytes;] ⁽¹⁾ and/or [II.4.7.3. they have been kept in a vector-protected establishment for at least 60 days prior to the date of and during collection of the oocytes;] ⁽¹⁾ and/or [II.4.7.4. they have been subjected to a serological test able to detect specific antibodies against all serotypes (1-24) of bluetongue virus, with negative results, between 28 and 60 days from the date of each collection of the oocytes;] ⁽¹⁾ and/or [II.4.7.5. they have been subjected to an agent identification test for bluetongue virus (serotypes 1-24), with negative results, on a blood sample taken on the date of collection of the oocytes;]] II.4.8. comply with at least one of the following conditions as regards infection with epizootic haemorrhagic disease virus (EHDV): ⁽¹⁾ either [II.4.8.1. they have been kept for at least 60 days prior to the date of and during collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾ in a third country or territory, or zone thereof where EHDV has not been reported for at least the preceding 2 years within a radius of 150 km of the establishments;] ^{(1) (13)} or [II.4.8.2. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to the date of and during collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾;] ⁽¹⁾ and/or [II.4.8.3. they have been kept in a vector-protected establishment for at least 60 days prior to the date of and during collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾;] ⁽¹⁾ or [II.4.8.4. were resident in the third country or territory or zone thereof of dispatch of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ of the consignment to the Union in which according to official findings the following serotypes of EHDV exist: … and have been subjected with negative results in each case to the following tests carried out in an official laboratory: ⁽¹⁾ either [II.4.8.4.1. a serological test able to detect specific antibodies against those serotypes of EHDV, with negative results, on blood samples taken between 28 and 60 days from the date of collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾;]] ⁽¹⁾ and/or [II.4.8.4.2. an agent identification test for EHDV, with negative results, on blood samples taken on the date of collection of the [oocytes] ⁽¹⁾[embryos] ⁽¹⁾.]] ^{(1) (6)} [II.4.9. comply with animal health requirements laid down in Part 1, Chapter III, of Annex II to Delegated Regulation (EU) 2020/686;] II.5. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I: II.5.1. have been collected, processed and stored in accordance with animal health requirements set out in [Part 2] ⁽¹⁾[Part 3] ⁽¹⁾ [Part 4] ⁽¹⁾ [Part 5] ⁽¹⁾and Part 6 of Annex III to Delegated Regulation (EU) 2020/686; II.5.2. are placed in straws or other packages on which the mark is applied in accordance with requirements provided for in Article 83, point (a), of Delegated Regulation (EU) 2020/692 and that mark is indicated in box I.27; II.5.3. are transported in a container which: II.5.3.1. was sealed and numbered prior to the date of dispatch to the Union by the embryo collection or production team under responsibility of the team veterinarian, or by an official veterinarian, and the seal bears the number as indicated in box I.19; II.5.3.2. has been cleaned and either disinfected or sterilised before use, or is single-use container; ^{(1) (7)} [II.5.3.3. has been filled in with a cryogenic agent which has not been previously used for other products;] ^{(1) (8)} [II.5.4. are placed in straws or other packages which are securely and hermetically sealed; II.5.5. are transported in a container where the different types are separated from each other by physical compartments or by being placed in secondary protective bags.] ^{(1) (9)} [II.6. The [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ of the consignment described in Part I were conceived by artificial insemination using semen coming from a semen collection centre, germinal product processing establishment or germinal product storage centre approved for the collection, processing and storage of semen by the competent authority of a third country or territory, or zone thereof listed in Annex IX to Implementing Regulation (EU) 2021/404 for semen of bovine animals or by the competent authority of a Member State, and were collected, processed and stored in accordance with the requirements of Part 1, Chapter I and Part 5, Chapters II and III, of Annex II, and Part 1 of Annex III to Delegated Regulation (EU) 2020/686.] ^{(1) (10)} [II.7. The following antibiotic or mixture of antibiotics ⁽¹¹⁾ has been added to the collection, processing, washing or storage media: … .] 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 certificate include the United Kingdom in respect of Northern Ireland. This animal health 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.11 : “Place of dispatch”: Indicate the unique approval number and the name and address of the embryo collection or production team of dispatch of the consignment of oocytes or embryos. Only embryo collection or production teams listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of oocytes or embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Species”: Select amongst “ Bos taurus ”, “ Bison bison ” or “ Bubalus bubalis ” as appropriate. “Type”: Specify if oocytes, in vivo derived embryos, in vitro produced embryos or micromanipulated embryos. “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where oocytes or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which oocytes or embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo collection or production team by which the oocytes or embryos of the consignment were collected or produced. “Quantity”: Indicate the number of straws or other packages with the same mark. “Test”: For BTV-test, indicate: “point II.4.7.4” or “point II.4.7.5”, or both; for EHD-test, indicate: “point II.4.8.4.1” or “point II.4.8.4.2”, or both, if relevant. Part II: ⁽¹⁾ Delete if not applicable. ⁽²⁾ Only for a third country or territory, or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404. ⁽³⁾ Only embryo collection or production teams listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. ⁽⁴⁾ Option available only for the consignment of in vivo derived embryos. ⁽⁵⁾ Manual of the International Embryo Technology Society — A procedural guide and general information for the use of embryo transfer technology emphasising sanitary procedures, published by the International Embryo Technology Society, 1 111 North Dunlap Avenue, Savoy, Illinois 61 874, USA (http://www.iets.org/). ⁽⁶⁾ Applicable for the consignment of oocytes and in vitro produced embryos. ⁽⁷⁾ Applicable for frozen oocytes or embryos. ⁽⁸⁾ Applicable for consignments where oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of bovine animals are placed and transported in one container. ⁽⁹⁾ Does not apply to oocytes. ⁽¹⁰⁾ Mandatory attestation in case antibiotics were added. ⁽¹¹⁾ Insert the name(s) of the antibiotic(s) added and its (their) concentration. ⁽¹²⁾ For the zones with an entry “SF-BTV” in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404. ⁽¹³⁾ For the zones with an entry “SF-EHD” in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.


Official veterinarian	Official veterinarian
Name (in capital letters)
Date	Qualification and title
Stamp	Signature

CHAPTER 43 MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF STOCKS OF IN VIVO DERIVED EMBRYOS OF BOVINE ANIMALS COLLECTED, PROCESSED AND STORED IN ACCORDANCE WITH COUNCIL DIRECTIVE 89/556/EEC BEFORE 21 APRIL 2021, DISPATCHED AFTER 20 APRIL 2021 BY THE EMBRYO COLLECTION TEAM BY WHICH THE EMBRYOS WERE COLLECTED (MODEL “BOV-in-vivo-EMB-B-ENTRY”)

Part I: Description of consignment


COUNTRY	Animal health 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

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


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

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

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

Type

Part II: Certification


COUNTRY	COUNTRY	Certificate model BOV-in-vivo-EMB-B-ENTRY	Certificate model BOV-in-vivo-EMB-B-ENTRY	Certificate model BOV-in-vivo-EMB-B-ENTRY	Certificate model BOV-in-vivo-EMB-B-ENTRY
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference


I, the undersigned, official veterinarian of the … certify that: (exporting country) ⁽¹⁾ II.1. The embryos to be exported: II.1.1. were collected in the exporting country, which according to official findings: II.1.1.1. was free from rinderpest during the 12 month period immediately prior to their collection; ⁽²⁾ either [II.1.1.2. was free from foot-and-mouth disease and lumpy skin disease during the 12 month period immediately prior to their collection and did not carry out vaccination against foot-and-mouth disease or lumpy skin disease during that period.] ⁽²⁾ or [II.1.1.2. was not free from foot-and-mouth disease or lumpy skin disease during the 12 months immediately prior to their collection or carried out vaccination against foot-and-mouth disease or lumpy skin disease during that period, and: — the embryos were not subjected to penetration of the zona pellucida, — the embryos were stored under approved conditions for at least 30 days immediately after their collection, — the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease or lumpy skin disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease or lumpy skin disease during the 30 days prior to, and at least the 30 days after, the embryos were collected.] II.1.2. were collected by the embryo collection team ⁽³⁾ which: — had been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC; — which carried out the collection, processing, storing and transport of the embryos in accordance with Chapter II of Annex A to Directive 89/556/EEC; — was subject to inspection by an official veterinarian at least twice a year. II.1.3. were collected and processed on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease in the 30 days immediately prior to their collection and until dispatch to the Union, in the case of fresh embryos, or during the 30 days after collection, in the case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.1.1.2. II.1.4. from the time of collection until 30 days thereafter or, in the case of fresh embryos until the day of their dispatch to the Union, they were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease. II.1.5. were collected from the donor females, which: II.1.5.1. were located, during the 30 days immediately prior to collection, on premises situated in an area of at least 10 km radius centred on them, on which, according to official findings, there was no occurrence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease; II.1.5.2. showed no clinical signs of disease on the day of collection; II.1.5.3. spent the 6 months immediately prior to collection within the territory of the exporting country in no more than two herds: — which, according to official findings, were free from tuberculosis during that time, — which, according to official findings, were free from brucellosis during that time, — which were free from enzootic bovine leukosis or in which no bovine animal showed clinical signs of enzootic bovine leukosis during the previous 3 years, — in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months. II.1.6. The embryos to be exported were conceived by artificial insemination using semen coming from semen collection or storage centres approved for the collection, processing and/or storage of semen by the competent authority of a third country or part thereof listed in Annex I to Implementing Decision 2011/630/EU ⁽⁴⁾ or by the competent authority of a Member State. Notes This animal health certificate is intended for the entry into the Union of embryos of bovine animals, including when the Union is not the final destination of the embryos. 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 certificate include the United Kingdom in respect of Northern Ireland. This animal health 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.11 : “Place of dispatch”: Indicate the unique approval number and the name and address of the embryo collection or production team of dispatch of the consignment of embryos. Only embryo collection or production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Species”: Select amongst “ Bos taurus ”, “ Bison bison” or “Bubalus bubalis ” as appropriate. “Type”: Select " in vivo derived embryos". “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo collection team by which the embryos of the consignment were collected, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. “Quantity”: Indicate the number of straws or other packages with the same mark. Part II: ⁽¹⁾ Only third country or territory, or zone thereof listed in Annex IX to Commission Implementing Regulation (EU) 2021/404 for embryos of bovine animals. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only embryo collection teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. ⁽⁴⁾ OJ L 247, 24.9.2011, p. 32.

I, the undersigned, official veterinarian of the … certify that: (exporting country) ⁽¹⁾ II.1. The embryos to be exported: II.1.1. were collected in the exporting country, which according to official findings: II.1.1.1. was free from rinderpest during the 12 month period immediately prior to their collection; ⁽²⁾ either [II.1.1.2. was free from foot-and-mouth disease and lumpy skin disease during the 12 month period immediately prior to their collection and did not carry out vaccination against foot-and-mouth disease or lumpy skin disease during that period.] ⁽²⁾ or [II.1.1.2. was not free from foot-and-mouth disease or lumpy skin disease during the 12 months immediately prior to their collection or carried out vaccination against foot-and-mouth disease or lumpy skin disease during that period, and: — the embryos were not subjected to penetration of the zona pellucida, — the embryos were stored under approved conditions for at least 30 days immediately after their collection, — the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease or lumpy skin disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease or lumpy skin disease during the 30 days prior to, and at least the 30 days after, the embryos were collected.] II.1.2. were collected by the embryo collection team ⁽³⁾ which: — had been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC; — which carried out the collection, processing, storing and transport of the embryos in accordance with Chapter II of Annex A to Directive 89/556/EEC; — was subject to inspection by an official veterinarian at least twice a year. II.1.3. were collected and processed on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease in the 30 days immediately prior to their collection and until dispatch to the Union, in the case of fresh embryos, or during the 30 days after collection, in the case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.1.1.2. II.1.4. from the time of collection until 30 days thereafter or, in the case of fresh embryos until the day of their dispatch to the Union, they were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease. II.1.5. were collected from the donor females, which: II.1.5.1. were located, during the 30 days immediately prior to collection, on premises situated in an area of at least 10 km radius centred on them, on which, according to official findings, there was no occurrence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease; II.1.5.2. showed no clinical signs of disease on the day of collection; II.1.5.3. spent the 6 months immediately prior to collection within the territory of the exporting country in no more than two herds: — which, according to official findings, were free from tuberculosis during that time, — which, according to official findings, were free from brucellosis during that time, — which were free from enzootic bovine leukosis or in which no bovine animal showed clinical signs of enzootic bovine leukosis during the previous 3 years, — in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months. II.1.6. The embryos to be exported were conceived by artificial insemination using semen coming from semen collection or storage centres approved for the collection, processing and/or storage of semen by the competent authority of a third country or part thereof listed in Annex I to Implementing Decision 2011/630/EU ⁽⁴⁾ or by the competent authority of a Member State. Notes This animal health certificate is intended for the entry into the Union of embryos of bovine animals, including when the Union is not the final destination of the embryos. 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 certificate include the United Kingdom in respect of Northern Ireland. This animal health 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.11 : “Place of dispatch”: Indicate the unique approval number and the name and address of the embryo collection or production team of dispatch of the consignment of embryos. Only embryo collection or production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Species”: Select amongst “ Bos taurus ”, “ Bison bison” or “Bubalus bubalis ” as appropriate. “Type”: Select " in vivo derived embryos". “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo collection team by which the embryos of the consignment were collected, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. “Quantity”: Indicate the number of straws or other packages with the same mark. Part II: ⁽¹⁾ Only third country or territory, or zone thereof listed in Annex IX to Commission Implementing Regulation (EU) 2021/404 for embryos of bovine animals. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only embryo collection teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. ⁽⁴⁾ OJ L 247, 24.9.2011, p. 32.


Official veterinarian	Official veterinarian
Name (in capital letters)
Date	Qualification and title
Stamp	Signature

CHAPTER 44 MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF STOCKS OF IN VITRO PRODUCED EMBRYOS OF BOVINE ANIMALS PRODUCED, PROCESSED AND STORED IN ACCORDANCE WITH COUNCIL DIRECTIVE 89/556/EEC BEFORE 21 APRIL 2021, CONCEIVED USING SEMEN COMPLYING WITH REQUIREMENTS OF COUNCIL DIRECTIVE 88/407/EEC, DISPATCHED AFTER 20 APRIL 2021 BY THE EMBRYO PRODUCTION TEAM BY WHICH THE EMBRYOS WERE PRODUCED (MODEL “BOV-in-vitro-EMB-C-ENTRY”)

Part I: Description of consignment


COUNTRY	Animal health 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

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


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

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

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

Type

Part II: Certification


COUNTRY	COUNTRY	Certificate model BOV-in-vitro-EMB-C-ENTRY	Certificate model BOV-in-vitro-EMB-C-ENTRY	Certificate model BOV-in-vitro-EMB-C-ENTRY	Certificate model BOV-in-vitro-EMB-C-ENTRY
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference


I, the undersigned, official veterinarian of … certify that: (exporting country) ⁽¹⁾ II.1. The embryos to be exported: II.1.1. were produced in the exporting country, which according to official findings: II.1.1.1. was free from rinderpest during the 12 month period immediately prior to their production; ⁽²⁾ either [II.1.1.2. was free from foot-and-mouth disease and lumpy skin disease during the 12 month period immediately prior to their production and did not carry out vaccination against foot-and-mouth disease or lumpy skin disease during that period.] ⁽²⁾ or [II.1.1.2. was not free from foot-and-mouth disease or lumpy skin disease during the 12 month period immediately prior to their production or carried out vaccination against foot-and-mouth disease or lumpy skin disease during that period, and: — the embryos were produced without penetration of the zona pellucida, — the embryos were stored under approved conditions for at least 30 days immediately after their production, — the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease or lumpy skin disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease or lumpy skin disease during the 30 days prior to, and at least the 30 days after, the oocytes were collected.] II.1.2. were produced by the embryo production team ⁽³⁾ which: — had been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC, — carried out the production, processing, storing and transport in accordance with Chapter II of Annex A to Directive 89/556/EEC, — was subject to inspection by an official veterinarian at least twice a year. II.2. The oocytes used in the production of the embryos to be exported were collected on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease in the 30 days immediately prior to their collection and until their dispatch to the Union, in the case of fresh embryos, or during the 30 days after collection, in the case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.1.1.2. II.3. From the time of collection of the oocytes until 30 days thereafter or, in the case of fresh embryos, until the day of dispatch, the embryos to be exported were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease. II.4. The donors of oocytes used in the production of the embryos to be exported: II.4.1. were located, during the 30 days immediately prior to collection of the oocytes, on premises situated in an area of at least 10-km radius on which, according to official findings, there was no occurrence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease; II.4.2. showed no clinical signs of disease on the day of collection; II.4.3. spent the 6 months immediately prior to collection within the territory of the exporting country in no more than two herds: — which, according to official findings, were free from tuberculosis during that time, — which, according to official findings, were free from brucellosis during that time, — which were free from enzootic bovine leukosis or in which no bovine animal showed clinical signs of enzootic bovine leukosis during the previous 3 years, — in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months; ⁽²⁾ either [II.4.4. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the oocytes.] ⁽²⁾ or [II.4.4. were kept during a seasonally free period or protected from the vector for at least 60 days prior to, and during, the collection of the oocytes, and the embryos were produced without penetration of the zona pellucida, except if the donors underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results and the embryos were stored for at least 30 days.] ⁽²⁾ or [II.4.4. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results, and the embryos were stored for at least 30 days.] ⁽²⁾ or [II.4.4. underwent an agent identification test, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of collection or the day of slaughtering and giving negative results – the embryos having been produced, in the latter case, without penetration of the zona pellucida.] II.5. The embryos to be exported were conceived by in vitro fertilisation using semen coming from semen collection or storage centres ⁽⁴⁾: ⁽²⁾ either [II.5.1. approved in accordance with Article 5(1) of Directive 88/407/EEC and located in a Member State of the European Union, and the semen complies with the requirements of Directive 88/407/EEC.] ⁽²⁾ or [II.5.1. approved in accordance with Article 9(1) of Directive 88/407/EEC and located in a third country or part thereof listed in Annex I to Implementing Decision 2011/630/EU, and the semen complies with the requirements set out in Section A of Part 1 of Annex II to that Decision.] Notes This animal health certificate is intended for the entry into the Union of embryos of bovine animals, including when the Union is not the final destination of the embryos. 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 certificate include the United Kingdom in respect of Northern Ireland. This animal health 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.11 : “Place of dispatch”: Indicate the unique approval number and the name and address of the embryo collection or production team of dispatch of the consignment of embryos. Only embryo collection or production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Species”: Select amongst “ Bos taurus ”, “ Bison bison” or “Bubalus bubalis ” as appropriate. “Type”: Select " in vitro produced embryos". “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo production team by which the embryos of the consignment were produced, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. “Quantity”: Indicate the number of straws or other packages with the same mark. Part II: ⁽¹⁾ Only third country or territory, or zone thereof listed in Annex IX to Commission Implementing Regulation (EU) 2021/404 for embryos of bovine animals. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only embryo production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. ⁽⁴⁾ Only semen collection centres approved by the competent authority of a third country or territory, or zone thereof listed in Annex IX to Implementing Regulation (EU) 2021/404 for semen of bovine animals or by the competent authority of a Member State.

I, the undersigned, official veterinarian of … certify that: (exporting country) ⁽¹⁾ II.1. The embryos to be exported: II.1.1. were produced in the exporting country, which according to official findings: II.1.1.1. was free from rinderpest during the 12 month period immediately prior to their production; ⁽²⁾ either [II.1.1.2. was free from foot-and-mouth disease and lumpy skin disease during the 12 month period immediately prior to their production and did not carry out vaccination against foot-and-mouth disease or lumpy skin disease during that period.] ⁽²⁾ or [II.1.1.2. was not free from foot-and-mouth disease or lumpy skin disease during the 12 month period immediately prior to their production or carried out vaccination against foot-and-mouth disease or lumpy skin disease during that period, and: — the embryos were produced without penetration of the zona pellucida, — the embryos were stored under approved conditions for at least 30 days immediately after their production, — the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease or lumpy skin disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease or lumpy skin disease during the 30 days prior to, and at least the 30 days after, the oocytes were collected.] II.1.2. were produced by the embryo production team ⁽³⁾ which: — had been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC, — carried out the production, processing, storing and transport in accordance with Chapter II of Annex A to Directive 89/556/EEC, — was subject to inspection by an official veterinarian at least twice a year. II.2. The oocytes used in the production of the embryos to be exported were collected on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease in the 30 days immediately prior to their collection and until their dispatch to the Union, in the case of fresh embryos, or during the 30 days after collection, in the case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.1.1.2. II.3. From the time of collection of the oocytes until 30 days thereafter or, in the case of fresh embryos, until the day of dispatch, the embryos to be exported were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease. II.4. The donors of oocytes used in the production of the embryos to be exported: II.4.1. were located, during the 30 days immediately prior to collection of the oocytes, on premises situated in an area of at least 10-km radius on which, according to official findings, there was no occurrence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease; II.4.2. showed no clinical signs of disease on the day of collection; II.4.3. spent the 6 months immediately prior to collection within the territory of the exporting country in no more than two herds: — which, according to official findings, were free from tuberculosis during that time, — which, according to official findings, were free from brucellosis during that time, — which were free from enzootic bovine leukosis or in which no bovine animal showed clinical signs of enzootic bovine leukosis during the previous 3 years, — in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months; ⁽²⁾ either [II.4.4. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the oocytes.] ⁽²⁾ or [II.4.4. were kept during a seasonally free period or protected from the vector for at least 60 days prior to, and during, the collection of the oocytes, and the embryos were produced without penetration of the zona pellucida, except if the donors underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results and the embryos were stored for at least 30 days.] ⁽²⁾ or [II.4.4. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results, and the embryos were stored for at least 30 days.] ⁽²⁾ or [II.4.4. underwent an agent identification test, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of collection or the day of slaughtering and giving negative results – the embryos having been produced, in the latter case, without penetration of the zona pellucida.] II.5. The embryos to be exported were conceived by in vitro fertilisation using semen coming from semen collection or storage centres ⁽⁴⁾: ⁽²⁾ either [II.5.1. approved in accordance with Article 5(1) of Directive 88/407/EEC and located in a Member State of the European Union, and the semen complies with the requirements of Directive 88/407/EEC.] ⁽²⁾ or [II.5.1. approved in accordance with Article 9(1) of Directive 88/407/EEC and located in a third country or part thereof listed in Annex I to Implementing Decision 2011/630/EU, and the semen complies with the requirements set out in Section A of Part 1 of Annex II to that Decision.] Notes This animal health certificate is intended for the entry into the Union of embryos of bovine animals, including when the Union is not the final destination of the embryos. 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 certificate include the United Kingdom in respect of Northern Ireland. This animal health 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.11 : “Place of dispatch”: Indicate the unique approval number and the name and address of the embryo collection or production team of dispatch of the consignment of embryos. Only embryo collection or production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Species”: Select amongst “ Bos taurus ”, “ Bison bison” or “Bubalus bubalis ” as appropriate. “Type”: Select " in vitro produced embryos". “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo production team by which the embryos of the consignment were produced, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. “Quantity”: Indicate the number of straws or other packages with the same mark. Part II: ⁽¹⁾ Only third country or territory, or zone thereof listed in Annex IX to Commission Implementing Regulation (EU) 2021/404 for embryos of bovine animals. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only embryo production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. ⁽⁴⁾ Only semen collection centres approved by the competent authority of a third country or territory, or zone thereof listed in Annex IX to Implementing Regulation (EU) 2021/404 for semen of bovine animals or by the competent authority of a Member State.


Official veterinarian	Official veterinarian
Name (in capital letters)
Date	Qualification and title
Stamp	Signature

CHAPTER 45 MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF STOCKS OF IN VITRO PRODUCED EMBRYOS OF BOVINE ANIMALS PRODUCED, PROCESSED AND STORED IN ACCORDANCE WITH COUNCIL DIRECTIVE 89/556/EEC BEFORE 21 APRIL 2021, CONCEIVED USING SEMEN COMING FROM SEMEN COLLECTION OR STORAGE CENTRES APPROVED BY THE COMPETENT AUTHORITY OF THE EXPORTING THIRD COUNTRY OR TERRITORY, DISPATCHED AFTER 20 APRIL 2021 BY THE EMBRYO PRODUCTION TEAM BY WHICH THE EMBRYOS WERE PRODUCED (MODEL “BOV-in-vitro-EMB-D-ENTRY”)

Part I: Description of consignment


COUNTRY	Animal health 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

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


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

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

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

Part II: Certification


COUNTRY	COUNTRY	Certificate model BOV-in-vitro-EMB-D-ENTRY	Certificate model BOV-in-vitro-EMB-D-ENTRY	Certificate model BOV-in-vitro-EMB-D-ENTRY	Certificate model BOV-in-vitro-EMB-D-ENTRY
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference


I, the undersigned, official veterinarian of … certify that: (exporting country) ⁽¹⁾ II.1. The embryos to be exported: II.1.1. were produced in the exporting country, which according to official findings: II.1.1.1 was free from rinderpest during the 12 month period immediately prior to their production; ⁽²⁾ either [II.1.1.2. was free from foot-and-mouth disease and lumpy skin disease during the 12 month period immediately prior to their production and did not carry out vaccination against foot-and-mouth disease or lumpy skin disease during that period.] ⁽²⁾ or [II.1.1.2. was not free from foot-and-mouth disease or lumpy skin disease during the 12 month period immediately prior to their production or carried out vaccination against foot-and-mouth disease or lumpy skin disease during that period, and: — the embryos were produced without penetration of the zona pellucida, — the embryos were stored under approved conditions for at least 30 days immediately after their production, — the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease or lumpy skin disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease or lumpy skin disease during the 30 days prior to, and at least the 30 days after, the oocytes were collected.] II.1.2. were produced by the embryo production team ⁽³⁾ which: — had been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC; — carried out the production, processing, storing and transport of the embryos in accordance with Chapter II of Annex A to Directive 89/556/EEC; — was subject to inspection by an official veterinarian at least twice a year. II.2. The oocytes used in the production of the embryos to be exported were collected on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease in the 30 days immediately prior to their collection and until their dispatch to the Union, in case of fresh embryos, or during the 30 days after collection, in case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.2.2. II.3. From the time of collection of the oocytes until 30 days thereafter or, in the case of fresh embryos, until the day of dispatch, the embryos to be exported were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease. II.4. The donors of oocytes used in the production of the embryos to be exported: II.4.1. were located, during the 30 days immediately prior to collection of the oocytes, on premises within a 10-km radius of which, according to official findings, there was no occurrence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease; II.4.2. showed no clinical signs of disease on the day of collection; II.4.3. spent the 6 months immediately prior to collection within the territory of the exporting country in no more than two herds: — which, according to official findings, were free from tuberculosis during that time, — which, according to official findings, were free from brucellosis during that time, — which were free from enzootic bovine leukosis or in which no animal showed clinical signs of enzootic bovine leukosis during the previous 3 years, — in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months. ⁽²⁾ either [II.4.4. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the oocytes.] ⁽²⁾ or [II.4.4. were kept during a seasonally-free period or protected from the vector for at least 60 days prior to, and during, the collection of the oocytes, and the embryos were produced without penetration of the zona pellucida, except if the donors underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results and the embryos were stored for at least 30 days.] ⁽²⁾ or [II.4.4. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results, and the embryos were stored for at least 30 days.] ⁽²⁾ or [II.4.4. underwent an agent identification test, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of collection or the day of slaughtering and giving negative results – the embryos having been produced, in the latter case, without penetration of the zona pellucida.] II.5. The embryos to be exported were conceived by in vitro fertilisation using semen coming from semen collection or storage centres approved for the collection, processing and/or storage of semen by the competent authority of a third country or a part thereof listed in Annex I to Implementing Decision 2011/630/EU ⁽⁴⁾ or by the competent authority of a Member State. Notes This animal health certificate is intended for the entry into the Union of embryos of bovine animals, including when the Union is not the final destination of the embryos. In accordance with Article 3, point (a), of Directive 89/556/EEC, the in vitro produced bovine embryos using semen from semen centres approved by the exporting third country or territory, entered into the Union subject to the conditions laid down in this animal health certificate are excluded from intra-Union trade. 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 certificate include the United Kingdom in respect of Northern Ireland. This animal health 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.11 : “Place of dispatch”: Indicate the unique approval number and the name and address of the embryo collection or production team of dispatch of the consignment of embryos. Only embryo collection or production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Species”: Select amongst “ Bos taurus ”, “ Bison bison ” or “ Bubalus bubalis ” as appropriate. “Type”: Select “ in vitro produced embryos”. “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo production team by which the embryos of the consignment were produced, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. “Quantity”: Indicate the number of straws or other packages with the same mark. Part II: ⁽¹⁾ Only third country or territory, or zone thereof listed in Annex IX to Commission Implementing Regulation (EU) 2021/404 for embryos of bovine animals. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only embryo production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. ⁽⁴⁾ Only third country or territory, or zone thereof listed in Annex IX to Implementing Regulation (EU) 2021/404 for semen of bovine animals.

I, the undersigned, official veterinarian of … certify that: (exporting country) ⁽¹⁾ II.1. The embryos to be exported: II.1.1. were produced in the exporting country, which according to official findings: II.1.1.1 was free from rinderpest during the 12 month period immediately prior to their production; ⁽²⁾ either [II.1.1.2. was free from foot-and-mouth disease and lumpy skin disease during the 12 month period immediately prior to their production and did not carry out vaccination against foot-and-mouth disease or lumpy skin disease during that period.] ⁽²⁾ or [II.1.1.2. was not free from foot-and-mouth disease or lumpy skin disease during the 12 month period immediately prior to their production or carried out vaccination against foot-and-mouth disease or lumpy skin disease during that period, and: — the embryos were produced without penetration of the zona pellucida, — the embryos were stored under approved conditions for at least 30 days immediately after their production, — the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease or lumpy skin disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease or lumpy skin disease during the 30 days prior to, and at least the 30 days after, the oocytes were collected.] II.1.2. were produced by the embryo production team ⁽³⁾ which: — had been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC; — carried out the production, processing, storing and transport of the embryos in accordance with Chapter II of Annex A to Directive 89/556/EEC; — was subject to inspection by an official veterinarian at least twice a year. II.2. The oocytes used in the production of the embryos to be exported were collected on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease in the 30 days immediately prior to their collection and until their dispatch to the Union, in case of fresh embryos, or during the 30 days after collection, in case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.2.2. II.3. From the time of collection of the oocytes until 30 days thereafter or, in the case of fresh embryos, until the day of dispatch, the embryos to be exported were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease. II.4. The donors of oocytes used in the production of the embryos to be exported: II.4.1. were located, during the 30 days immediately prior to collection of the oocytes, on premises within a 10-km radius of which, according to official findings, there was no occurrence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease; II.4.2. showed no clinical signs of disease on the day of collection; II.4.3. spent the 6 months immediately prior to collection within the territory of the exporting country in no more than two herds: — which, according to official findings, were free from tuberculosis during that time, — which, according to official findings, were free from brucellosis during that time, — which were free from enzootic bovine leukosis or in which no animal showed clinical signs of enzootic bovine leukosis during the previous 3 years, — in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months. ⁽²⁾ either [II.4.4. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the oocytes.] ⁽²⁾ or [II.4.4. were kept during a seasonally-free period or protected from the vector for at least 60 days prior to, and during, the collection of the oocytes, and the embryos were produced without penetration of the zona pellucida, except if the donors underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results and the embryos were stored for at least 30 days.] ⁽²⁾ or [II.4.4. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results, and the embryos were stored for at least 30 days.] ⁽²⁾ or [II.4.4. underwent an agent identification test, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of collection or the day of slaughtering and giving negative results – the embryos having been produced, in the latter case, without penetration of the zona pellucida.] II.5. The embryos to be exported were conceived by in vitro fertilisation using semen coming from semen collection or storage centres approved for the collection, processing and/or storage of semen by the competent authority of a third country or a part thereof listed in Annex I to Implementing Decision 2011/630/EU ⁽⁴⁾ or by the competent authority of a Member State. Notes This animal health certificate is intended for the entry into the Union of embryos of bovine animals, including when the Union is not the final destination of the embryos. In accordance with Article 3, point (a), of Directive 89/556/EEC, the in vitro produced bovine embryos using semen from semen centres approved by the exporting third country or territory, entered into the Union subject to the conditions laid down in this animal health certificate are excluded from intra-Union trade. 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 certificate include the United Kingdom in respect of Northern Ireland. This animal health 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.11 : “Place of dispatch”: Indicate the unique approval number and the name and address of the embryo collection or production team of dispatch of the consignment of embryos. Only embryo collection or production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Species”: Select amongst “ Bos taurus ”, “ Bison bison ” or “ Bubalus bubalis ” as appropriate. “Type”: Select “ in vitro produced embryos”. “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo production team by which the embryos of the consignment were produced, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. “Quantity”: Indicate the number of straws or other packages with the same mark. Part II: ⁽¹⁾ Only third country or territory, or zone thereof listed in Annex IX to Commission Implementing Regulation (EU) 2021/404 for embryos of bovine animals. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only embryo production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm. ⁽⁴⁾ Only third country or territory, or zone thereof listed in Annex IX to Implementing Regulation (EU) 2021/404 for semen of bovine animals.


Official veterinarian	Official veterinarian
Name (in capital letters)
Date	Qualification and title
Stamp	Signature

CHAPTER 46 MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF GERMINAL PRODUCTS LISTED BELOW, DISPATCHED AFTER 20 APRIL 2021 FROM THE GERMINAL PRODUCT PROCESSING ESTABLISHMENT:

— semen of bovine animals collected, processed and stored in accordance with Regulation (EU) 2016/429 of the European Parliament and of the Council and Commission Delegated Regulation (EU) 2020/692 after 20 April 2021;

— stocks of semen of bovine animals collected, processed and stored in accordance with Council Directive 88/407/EEC as amended by Council Directive 2003/43/EC, after 31 December 2004 and before 21 April 2021;

— stocks of semen of bovine animals collected, processed and stored in accordance with Directive 88/407/EEC as amended by Council Directive 93/60/EEC, before 1 January 2005;

— oocytes and embryos of bovine animals collected or produced, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/692 after 20 April 2021;

— stocks of in vivo derived embryos of bovine animals collected, processed and stored in accordance with Council Directive 89/556/EEC before 21 April 2021;

— stocks of in vitro produced embryos of bovine animals produced, processed and stored in accordance with Directive 89/556/EEC before 21 April 2021, and conceived using semen complying with requirements of Directive 88/407/EEC;

— stocks of in vitro produced embryos of bovine animals produced, processed and stored in accordance with Directive 89/556/EEC before 21 April 2021, and conceived using semen coming from semen collection or storage centres approved by the competent authority of the exporting third country or territory.

(MODEL “BOV-GP-PROCESSING-ENTRY”)

Part I: Description of consignment

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