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
--- ---
I.1 Consignor/Exporter
Name
Address
Address
Country
I.5 Consignee/Importer
Name
Address
Country
I.7 Country of origin
I.8 Region of origin
I.11 Place of dispatch
Name
Address
Country
I.13 Place of loading
--- ---
I.15 Means of transport
☐ Aircraft
☐ Railway
Identification
Identification
--- ---
I.18 Transport conditions
I.19 Container number/Seal number
Container No
I.20 Certified as or for
☐ Germinal products ☐ Germinal products
--- ---
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-GP-PROCESSING-ENTRY Certificate model BOV-GP-PROCESSING-ENTRY Certificate model BOV-GP-PROCESSING-ENTRY Certificate model BOV-GP-PROCESSING-ENTRY
II. Health information II.a Certificate reference II.b IMSOC reference
I, the undersigned official veterinarian, hereby certify that: II.1. The germinal product processing establishment (1) described in box I.11 at which the [semen] (2) [oocytes] (2) [in vivo derived embryos] (2) [in vitro produced embryos] (2) [micromanipulated embryos] (2) to be dispatched to the Union was/were processed and stored: II.1.1. is located in a third country or territory, or zone thereof: II.1.1.1. authorised for the entry into the Union of [semen] (2) [oocytes] (2) [embryos] (2) of bovine animals and listed in Annex IX to Commission Implementing Regulation (EU) 2021/404; (2) either [II.1.1.2. where foot and mouth disease was not reported for at least 24 months immediately prior to the date of [collection] (2/ [production] (2) of the [semen] (2) [oocytes] (2) [embryos] (2) and until the date of its/their dispatch;] (2) (3) or [II.1.1.2. 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] (2) [production] (2) of the [semen] (2) [oocytes] (2) [embryos] (2) and until the date of its/their dispatch;] II.1.1.3. 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] (2) [production] (2) of the [semen] (2) [oocytes] (2) [embryos] (2) and until the date of its/their dispatch; II.1.1.4. 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] (2) [production] (2) of the [semen] (2) [oocytes] (2) [embryos] (2) and until the date of its/their dispatch, and no vaccinated animals entered into the third country or territory, or zone thereof during that period, and (2) 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;] (2) 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;] II.1.2. is approved and listed by the competent authority of the third country or territory; II.1.3. complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Part 4 of Annex I to Commission Delegated Regulation (EU) 2020/686.] II.2. The [semen] (2) [oocytes] (2) [embryos] (2) described in Part I is/are intended for artificial reproduction, and: II.2.1. has/have been [collected] (2) [produced] (2), [processed] (2) [stored] (2) [in a semen collection centre] (2) (4) [by an embryo collection team] (2) (4) [by an embryo production team] (2) (4) and [processed] (2) [stored] (2) in a germinal product processing establishment (4) [and stored in a germinal product storage centre] (2) (4) complying with requirements set out in [Part 1] (2) [Part 2] (2) [Part 3] (2) [Part 4] (2) [Part 5] (2) of Annex I to Delegated Regulation (EU) 2020/686, and: (2) either [located in the third country or territory of dispatch into the Union;] (2) (5) and/or [located in …, and has/have been introduced into the third country or territory of dispatch to the Union under conditions at least as strict as for the entry into the Union of [semen] (2) [oocytes] (2) [embryos] (2) of bovine animals in accordance with Regulation (EU) 2016/429 and Commission Delegated Regulation(EU) 2020/692;] II.2.2. was/were moved to the germinal product processing establishment described in box I.11 under conditions at least as strict as described in: (2) either [Model BOV-SEM-A-ENTRY (6);] (2) and/or [Model BOV-SEM-B-ENTRY (6);] (2) and/or [Model BOV-SEM-C-ENTRY (6);] (2) and/or [Model BOV-OOCYTES-EMB-A-ENTRY (6);] (2) and/or [Model BOV-in-vivo-EMB-B-ENTRY (6);] (2) and/or [Model BOV-in-vitro-EMB-C-ENTRY (6);] (2) and/or [Model BOV-in-vitro-EMB-D-ENTRY (6);] (2) and/or [Model BOV-GP-PROCESSING-ENTRY (6);] (2) and/or [Model BOV-GP-STORAGE-ENTRY (6);]] II.2.3. has/have been collected, processed and stored in accordance with animal health requirements set out in Annex III to Delegated Regulation (EU) 2020/686; II.2.4. is/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.2.5. is/are transported in a container which: II.2.5.1. was sealed and numbered prior to the date of dispatch from the germinal product processing establishment under responsibility of the centre veterinarian, or by an official veterinarian, and the seal bears the number as indicated in box I.19; II.2.5.2. has been cleaned and either disinfected or sterilised before use, or is single-use container; (2) (7) [II.2.5.3. has been filled in with a cryogenic agent which has not been previously used for other products.] (2) (8) [II.2.6. is/are placed in straws or other packages which are securely and hermetically sealed; II.2.7. is/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.] Notes This animal health certificate is intended for the entry into the Union of semen, oocytes and embryos of bovine animals, including when the Union is not the final destination of the semen, oocytes and 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 germinal product processing establishment of dispatch of the consignment of semen, oocytes and/or embryos. Only germinal product processing establishments 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 semen, oocytes and/or embryos. Box reference I.17 : “Accompanying documents”: Number(s) of related original certificate(s) shall correspond to the serial number of the individual official document(s) or animal health certificate(s) that accompanied the semen, oocytes and/or embryos described in Part I from the semen collection centre where the semen was collected, and/or from the embryo collection team and/or the embryo production team by which the oocytes and/or embryos were collected or produced, and/or from the germinal product processing establishment where the semen, oocytes or embryos were processed and stored, and/or from the germinal product storage centre where the semen, oocytes or embryos were stored, to the germinal product processing establishment described in box I.11. The original(s) of those document(s) or those certificate(s) or the officially endorsed copies thereof shall be attached to this animal health certificate. 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 semen, in vivo derived embryos, in vivo derived oocytes, in vitro produced embryos or micromanipulated embryos. “Identification number”: Indicate identification number of each donor animal. “Identification mark”: Indicate mark on the straw or other packages where semen, oocytes and/or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which semen, oocytes and/or embryos of the consignment was/were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the semen collection centre, where the semen of the consignment was collected, and/or of the embryo collection team and/or the embryo production team by which oocytes or embryos of the consignment were collected or produced. “Quantity”: Indicate number of straws or other packages with the same mark. Part II: (1) Only germinal product processing establishments 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. (2) Delete if not applicable. (3) 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. (4) Only approved germinal product establishments 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/index_en.htm. (5) Only a third country or territory, or zone thereof listed in Annex IX to Implementing Regulation (EU) 2021/404 and the Member States. (6) The original(s) of the document(s) or the animal health certificate(s) or the officially endorsed copies thereof that accompanied the semen, oocytes or embryos described in Part I from the semen collection centre where the semen was collected, and/or from the embryo collection team or the embryo production team by which the oocytes and/or embryos were collected or produced, and/or from the germinal product processing establishment where the semen, oocytes or embryos were processed and stored, and/or from the germinal product storage centre where the semen, oocytes or embryos were stored, to the germinal product processing establishment of dispatch of the semen, oocytes and/or embryos described in box I.11 shall be attached to this animal health certificate. (7) Applicable for frozen semen, oocytes or embryos. (8) Applicable for consignments where semen, oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of bovine animals are placed and transported in one container.
Official veterinarian Official veterinarian
Name (in capital letters)
Date Qualification and title
Stamp Signature

CHAPTER 47

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 STORAGE CENTRE:

(MODEL “BOV-GP-STORAGE-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
Identification
--- ---
I.18 Transport conditions
I.19 Container number/Seal number
Container No
I.20 Certified as or for
☐ Germinal products ☐ Germinal products
--- ---
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-GP-STORAGE-ENTRY Certificate model BOV-GP-STORAGE-ENTRY Certificate model BOV-GP-STORAGE-ENTRY Certificate model BOV-GP-STORAGE-ENTRY
II. Health information II.a Certificate reference II.b IMSOC reference
I, the undersigned official veterinarian, hereby certify that: II.1. The germinal product storage centre (1) described in box I.11 at which the [semen] (2) [oocytes] (2) [in vivo derived embryos] (2) [in vitro produced embryos] (2) [micromanipulated embryos] (2) to be dispatched to the Union was/were stored: II.1.1. is located in a third country or territory, or zone thereof: II.1.1.1. authorised for the entry into the Union of [semen] (2) [oocytes] (2) [embryos] (2) of bovine animals and listed in Annex IX to Commission Implementing Regulation (EU) 2021/404; (2) either [II.1.1.2. where foot and mouth disease was not reported for at least 24 months immediately prior to the date of [collection] (2) [production] (2) of the [semen] (2) [oocytes] (2) [embryos] (2) and until the date of its/their dispatch;] (2) (3) or [II.1.1.2. 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] (2) [production] (2) of the [semen] (2) [oocytes] (2) [embryos] (2) and until the date of its/their dispatch;] II.1.1.3. 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] (2) [production] (2) of the [semen] (2) [oocytes] (2) [embryos] (2) and until the date of its/their dispatch; II.1.1.4. 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] (2) [production] (2) of the [semen] (2) [oocytes] (2) [embryos] (2) and until the date of its/their dispatch, and no vaccinated animals entered into the third country or territory, or zone thereof during that period, and (2) 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;] (2) 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;] II.1.2. is approved and listed by the competent authority of the third country or territory; II.1.3. complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Part 5 of Annex I to Commission Delegated Regulation (EU) 2020/686. II.2. The [semen] (2) [oocytes] (2) [embryos] (2) described in Part I is/are intended for artificial reproduction and: II.2.1. has/have been [collected] (2) [produced] (2) [processed] (2) [stored] (2) [in a semen collection centre] (2) (4) [by an embryo collection team] (2) (4) [by an embryo production team] (2) (4), [and] (2) [processed] (2) [stored] (2) [in a germinal product processing establishment] (2) (4) and stored in a germinal product storage centre (4) complying with requirements set out in [Part 1] (2) [Part 2] (2) [Part 3] (2) [Part 4] (2) [Part 5] (2) of Annex I to Delegated Regulation (EU) 2020/686, and: (2) either [located in the third country or territory of dispatch to the Union;] (2) (5) and/or [located in …, and has/have been introduced into the third country or territory of dispatch to the Union under conditions at least as strict as for the entry into the Union of [semen] (2) [oocytes] (2) [in vivo derived embryos] (2) [in vitro produced embryos] (2) of bovine animals in accordance with Regulation (EU) 2016/429 and Commission Delegated Regulation (EU) 2020/692;] II.2.2. was/were moved to the germinal product storage centre described in box I.11 under conditions at least as strict as described in: (2) either [Model BOV-SEM-A-ENTRY (6);] (2) and/or [Model BOV-SEM-B-ENTRY (6);] (2) and/or [Model BOV-SEM-C-ENTRY (6);] (2) and/or [Model 1 in Section A of Part 1 of Annex II to Commission Implementing Decision 2011/630/EU (6);] (2) and/or [Model 2 in Section B of Part 1 of Annex II to Implementing Decision 2011/630/EU (6);] (2 ) and/or [Model 3 in Section C of Part 1 of Annex II to Implementing Decision 2011/630/EU (6);] (2) and/or [Model BOV-OOCYTES-EMB-A-ENTRY (6);] (2) and/or [Model BOV-in-vivo-EMB-B-ENTRY (6);] (2) and/or [Model BOV-in-vitro-EMB-C-ENTRY (6);] (2) and/or [Model BOV-in-vitro-EMB-D-ENTRY (6);] (2) and/or [Model BOV-GP-PROCESSING-ENTRY (6);] (2) and/or [Model BOV-GP-STORAGE-ENTRY (6);]] II.2.3. has/have been collected, processed and stored in accordance with animal health requirements set out in Annex III to Delegated Regulation (EU) 2020/686; II.2.4. is/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.2.5. is/are transported in a container which: II.2.5.1. was sealed and numbered prior to the date of dispatch from the germinal product storage centre under responsibility of the centre veterinarian, or by an official veterinarian, and the seal bears the number as indicated in box I.19; II.2.5.2. has been cleaned and either disinfected or sterilised before use, or is single-use container; (2) (7) [II.2.5.3. has been filled in with a cryogenic agent which has not been previously used for other products.] (2) (8) [II.2.6. is/are placed in straws or other packages which are securely and hermetically sealed; II.2.7. is/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.] Notes This animal health certificate is intended for the entry into the Union of semen, oocytes and embryos of bovine animals, including when the Union is not the final destination of the semen, oocytes and 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 germinal product storage centre of dispatch of the consignment of semen, oocytes and/or embryos. Only germinal product storage centre 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 semen, oocytes and/or embryos. Box reference I.17 : “Accompanying documents”: Number(s) of related original animal health certificate(s) shall correspond to the serial number of the individual official document(s) or animal health certificate(s) that accompanied the semen, oocytes and/or embryos described in Part I from the semen collection centre, where the semen was collected, and/or from the embryo collection team and/or the embryo production team by which the oocytes and/or embryos were collected or produced, and/or from the germinal product processing establishment where the semen, oocytes or embryos were processed and stored, and/or from the germinal product storage centre where the semen, oocytes or embryos were stored, to the germinal product storage centre described in box I.11. The original(s) of those document(s) or those animal health certificate(s) or the officially endorsed copies thereof shall be attached to this animal health certificate. 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 semen, in vivo derived embryos, in vivo derived oocytes, in vitro produced embryos or micromanipulated embryos. “Identification number”: Indicate identification number of each donor animal. “Identification mark”: Indicate mark on the straw or other packages where semen, oocytes and/or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which semen, oocytes and/or embryos of the consignment was/were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the semen collection centre, where the semen of the consignment was collected, and/or of the embryo collection team and/or the embryo production team by which oocytes or embryos of the consignment were collected or produced. “Quantity”: Indicate number of straws or other packages with the same mark. Part II: (1) Only germinal product storage centres 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. (2) Delete if not applicable. (3) 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. (4) Only approved germinal product establishments 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/index_en.htm. (5) Only a third country or territory, or zone thereof listed in Annex IX to Implementing Regulation (EU) 2021/404 and the Member States. (6) The original(s) of the document(s) or the animal health certificate(s) or the officially endorsed copies of thereof that accompanied the semen, oocytes or embryos described in Part I from the semen collection centre, where the semen was collected, and/or from the embryo collection team or the embryo production team by which the oocytes and/or embryos were collected or produced, and/or from the germinal product processing establishment where the semen, oocytes or embryos were processed and stored, and/or from the germinal product storage centre where the semen, oocytes or embryos were stored, to the germinal product storage centre of dispatch of the semen, oocytes and/or embryos described in box I.11 shall be attached to this animal health certificate. (7) Applicable for frozen semen, oocytes or embryos. (8) Applicable for consignments where semen, oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of bovine animals are placed and transported in one container.
Official veterinarian Official veterinarian
Name (in capital letters)
Date Qualification and title
Stamp Signature

CHAPTER 48

MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF SEMEN OF OVINE AND CAPRINE 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, DISPATCHED FROM THE SEMEN COLLECTION CENTRE WHERE THE SEMEN WAS COLLECTED (MODEL “OV/CAP-SEM-A-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 OV/CAP-SEM-A-ENTRY Certificate model OV/CAP-SEM-A-ENTRY Certificate model OV/CAP-SEM-A-ENTRY Certificate model OV/CAP-SEM-A-ENTRY
II. Health information II.a Certificate reference II.b IMSOC reference
I, the undersigned official veterinarian, hereby certify that: II.1. The semen of the consignment described in Part I is intended for artificial reproduction and was 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 semen of [ovine] (1) [caprine] (1) animals and listed in Annex X 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 of the semen and until the date of dispatch of the consignment to the Union;] (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 semen and until the date of dispatch of the consignment to the Union;] II.1.3. where infection with rinderpest virus, infection with Rift Valley fever virus, infection with peste des petits ruminants virus, sheep pox and goat pox and contagious caprine pleuropneumonia were not reported for at least 12 months immediately prior to the date of collection of the semen and until the date of dispatch of the consignment to the Union; II.1.4. where no vaccination against infection with rinderpest virus, infection with Rift Valley fever virus, infection with peste des petits ruminants virus, sheep pox and goat pox and contagious caprine pleuropneumonia has been carried out for at least 12 months immediately prior to the date of collection of the semen and until the date of dispatch of the consignment to the Union, 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;] II.2. The semen described in Part I was obtained from donor animals which originated, prior to the date of commencement of the quarantine referred to in point II.4.6, from establishments: II.2.1. 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 and in which foot and mouth disease has not been reported during at least 3 months, and (1) either [they were not vaccinated against foot and mouth disease;] (1) or [they were vaccinated against foot and mouth disease during the last 12 months prior to the date of collection of the semen but not during the last 30 days immediately prior to the date of collection of the semen, and 5% (with a minimum of five straws) of each quantity of semen taken from a donor animal at any time is submitted to a virus isolation test for foot and mouth disease with negative results;] II.2.2. 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) (3) [II.2.3. in which infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has not been reported during the last 42 days;] (1) (5) [II.2.3. which are subjected to surveillance to detect infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) in caprine animals in accordance with procedures provided for in Part 1, points 1 and 2, of Annex II to Commission Delegated Regulation (EU) 2020/688 during at least 12 months and during that period: (i) only caprine animals from establishments applying such surveillance have been introduced therein; (1) either [(ii) infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has not been reported in the animals of the same species kept therein.]] (1) or [(ii) infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has been reported in caprine animals kept therein and measures were taken in accordance with Part 1, point 3, of Annex II to Delegated Regulation (EU) 2020/688;]] II.2.4. in which (1) either [surra (Trypanosoma evansi) has not been reported during the last 2 years;] (1) or [surra (Trypanosoma evansi) has not been reported during the last 30 days and when the disease was reported in the establishments during the last 2 years, 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;] (1) (3) [II.2.5. where they have remained for a continuous period of at least 30 days and where ovine epididymitis (Brucella ovis) has not been reported during the last 12 months;] (1) (4) [II.2.6. where, during the last 30 days prior to their stay in the quarantine accommodation referred to in point II.4.6, they have been subjected to a serological test for ovine epididymitis (Brucella ovis) or any other test with an equivalent documented sensitivity and specificity, with negative results, required in accordance with Part 3, Chapter I, point 1(b), of Annex II to Delegated Regulation (EU) 2020/686;] (1) (5) [II.2.7. where infection with Burkholderia mallei (glanders) was not reported during the last 6 months.] II.3. The semen described in Part I has been collected, processed and stored, and dispatched from the semen collection centre (6) which: II.3.1. is approved and listed by the competent authority of the third country or territory; II.3.2. complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Part 1 of Annex I to Delegated Regulation (EU) 2020/686. II.4. The semen described in Part I was obtained from donor animals which: II.4.1. were not vaccinated against infection with rinderpest virus, infection with Rift Valley fever virus, infection with peste des petits ruminants virus, sheep pox and goat pox and contagious caprine pleuropneumonia; II.4.2. remained for at least 6 months prior to the date of collection of the semen in a third country or territory, or zone thereof referred to in box I.7.; II.4.3. did not show symptoms or clinical signs of transmissible animal diseases on the date of their admission to a semen collection centre and on the date of collection of the semen; II.4.4. are individually identified as provided for in Article 21(1) of Delegated Regulation (EU) 2020/692; II.4.5. for at least 30 days prior to the date of collection of the semen and during the collection period: II.4.5.1. 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, infection with peste des petits ruminants virus, sheep pox and goat pox or contagious caprine pleuropneumonia, or of an emerging disease relevant for ovine and caprine animals; II.4.5.2. 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), infection with epizootic haemorrhagic disease virus, infection with bluetongue virus (serotypes 1-24) and, in the case of ovine animals and those caprine animals which are kept together with the ovine animals, ovine epididymitis (Brucella ovis) have not been reported; II.4.5.3. were not in contact with animals from establishments situated in a restricted zone due to the occurrence of diseases referred to in point II.4.5.1 or from establishments which do not meet the conditions referred to in point II.4.5.2; II.4.5.4. were not used for natural breeding; II.4.6. have been subjected to a quarantine for at least 28 days in a quarantine accommodation, where only other cloven-hoofed animals with at least the same health status were present, which on the date of their admission to the semen collection centre complied with the following conditions: II.4.6.1. it was not situated in a restricted zone established due to diseases referred to in point II.4.5.1; II.4.6.2. none of the diseases referred to in point II.4.5.2 has been reported for at least 30 days; II.4.6.3. it was situated in an area where foot and mouth disease has not been reported within a 10-km radius centred on the quarantine accommodation for at least 30 days; II.4.6.4. has had no outbreak of foot and mouth disease reported during at least 3 months preceding the date of admission of the animals into the semen collection centre; II.4.7. were kept in the semen collection centre: II.4.7.1. which was not situated in a restricted zone established due to diseases referred to in point II.4.5.1; II.4.7.2. where none of the diseases referred to in point II.4.5.2 has been reported for at least 30 days prior to the date of collection of the semen, and (1) (7) either [at least 30 days following the date of collection of the semen;] (1) (8) or [until the date of dispatch of the consignment to the Union;] II.4.7.3. situated in an area where foot and mouth disease has not been reported within a 10-km radius centred on the semen collection centre for at least 30 days, and (1) (7) either [free from foot and mouth disease for at least 3 months prior to the date of collection of the semen and 30 days following the date of collection of the semen;] (1) (8) or [free from foot and mouth disease for at least 3 months prior to the date of collection of the semen and until the date of dispatch of the consignment to the Union and they have been kept at that semen collection centre for a continuous period of at least 30 days immediately prior to the date of collection of the semen;] II.4.8. comply with at least one of the following conditions as regards infection with bluetongue virus (serotypes 1-24): (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 semen in a third country or territory, or 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) (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 semen;] (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 semen;] (1) and/or [II.4.8.4. 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 semen;] (1) and/or [II.4.8.5. they have been subjected to an agent identification test for bluetongue virus (serotypes 1-24), with negative results, on blood samples taken at the date of commencement and the date of final collection of the semen and during collection of the semen at intervals of at least every 7 days, in the case of the virus isolation test, or of at least every 28 days, in the case of PCR;] II.4.9. comply with at least one of the following conditions as regards infection with epizootic haemorrhagic disease virus (EHDV): (1) either [II.4.9.1. they have been kept for at least 60 days prior to the date of and during collection of the semen in a third country or territory, or zone thereof where EHDV has not been reported within a radius of 150 km of the establishment for at least 2 years;] (1) (14) or [II.4.9.2. 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 semen;] (1) and/or [II.4.9.3. they have been kept in a vector-protected establishment for at least 60 days prior to and during collection of the semen;] (1) or [II.4.9.4. were resident in the third country or territory of dispatch 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.4.9.4.1. a serological test able to detect specific antibodies against those serotypes of EHDV, with negative results, at least every 60 days throughout the collection period and between 28 and 60 days from the date of the final collection of the semen;]] (1) and/or [II.4.9.4.2. an agent identification test for EHDV, with negative results, on blood samples taken at the commencement and final collection of the semen and during the collection of the semen at intervals of at least every 7 days, in the case of virus isolation test, or of at least every 28 days, in the case of PCR.]] II.4.10. have been subjected to the following tests, carried out on samples taken within the of the last 30 days prior to the date of commencement of the quarantine referred to in point II.4.6, with negative results, required in accordance with Part 3, Chapter I, point 1(c), of Annex II to Delegated Regulation (EU) 2020/686: II.4.10.1. for infection with Brucella abortus, B. melitensis and B. suis, a serological test referred to in Part 1, point 1, of Annex I to Delegated Regulation (EU) 2020/688; (1) (9) [II.4.10.2. for ovine epididymitis (Brucella ovis), a serological test or any other test with an equivalent documented sensitivity and specificity;] II.4.11. have been subjected to the following tests, carried out on samples taken at least 21 days after the commencement of the quarantine referred to in point II.4.6, with negative results, required in accordance with Part 3, Chapter I, point 1(d), of Annex II to Delegated Regulation (EU) 2020/686: II.4.11.1. for infection with Brucella abortus, B. melitensis and B. suis, a serological test referred to in Part 1, point 1, of Annex I to Delegated Regulation (EU) 2020/688; (1) (9) [II.4.11.2. for ovine epididymitis (Brucella ovis), a serological test or any other test with an equivalent documented sensitivity and specificity;] II.4.12. have been subjected at semen collection centre, at least once a year, to the following compulsory routine tests, required in accordance with Part 3, Chapter I, point 2, of Annex II to Delegated Regulation (EU) 2020/686: II.4.12.1. for infection with Brucella abortus, B. melitensis and B. suis, a serological test referred to in Part 1, point 1, of Annex I to Delegated Regulation (EU) 2020/688; (1) (9) [II.4.12.2. for ovine epididymitis (Brucella ovis), a serological test or any other test with an equivalent documented sensitivity and specificity.]] (10) [II.4.13. comply with the following conditions as regards classical scrapie: II.4.13.1. they have been kept continuously since birth in a third country or territory where the following conditions are fulfilled: II.4.13.1.1. classical scrapie is compulsorily notifiable; II.4.13.1.2. an awareness, surveillance and monitoring system is in place; II.4.13.1.3. ovine and caprine animals affected with classical scrapie are killed and completely destroyed; II.4.13.1.4. the feeding to ovine and caprine animals of meat-and-bone meal, or greaves of ruminant origin, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health, has been banned and effectively enforced in the whole third country or territory for at least 7 years; (1) either [II.4.13.2. they have been kept continuously for the last 3 years prior to the date of collection of the semen to be dispatched to the Union in a holding or holdings which has/have fulfilled during that period all the requirements set out Chapter A, Section A, points 1.3.(a) to (f), of Annex VIII to Regulation (EC) No 999/2001, except during the period when they were kept at a semen collection centre that complied during that period with the conditions set out in Chapter A, Section A, point 1.3.(c)(iv), of Annex VIII to that Regulation.]] (1) or [II.4.13.2. they are ovine animals of the ARR/ARR prion protein genotype.]] (1) (15) or [II.4.13.2. they are caprine animals carrying at least one of the K222, D146 or S146 alleles.]] II.5. The semen of the consignment described in Part I: II.5.1. has been collected, processed and stored in accordance with animal health requirements set out in Part 1, points 1 and 2, of Annex III to Delegated Regulation (EU) 2020/686; II.5.2. is 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. is transported in a container which: II.5.3.1. was sealed and numbered prior to the date of dispatch from the semen collection centre under responsibility of the centre 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) (11) [II.6. Where an antibiotic or a mixture of antibiotics was added to the semen: II.6.1. The following antibiotic or mixture of antibiotics has been added to the semen after final dilution, or is contained in the used semen diluents: … (12), II.6.2. Immediately after the addition of the antibiotic(s), and before any possible freezing, the diluted semen was kept at a temperature of at least 5 °C, or under a time-temperature regime with a documented equivalent bactericidal activity.] Notes This animal health certificate is intended for the entry into the Union of semen of ovine and caprine animals, including when the Union is not the final destination of the semen. 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 semen collection centre of dispatch of the consignment of semen. Only semen collection centres listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/index_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 semen. 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 “ Ovis aries ” or “ Capra hircus ” as appropriate. “Type”: Indicate semen. “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where semen of the consignment is placed. “Date of collection/production”: Indicate the date on which semen of the consignment was collected. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the semen collection centre where the semen of the consignment was collected. “Quantity”: Indicate the number of straws or other packages with the same mark. “Test”: For BTV-test, indicate: “point II.4.8.4” or “point II.4.8.5”, or both, for EHD-test, indicate: “point II.4.9.4.1” or “point II.4.9.4.2”, 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) Applicable for ovine animals. (4) Applicable for ovine animals and for those caprine animals which are kept together with ovine animals. (5) Applicable for caprine animals. (6) Only semen collection centres listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htm. (7) Applicable for frozen semen. (8) Applicable for fresh and chilled semen. (9) Applicable for ovine animals and for those caprine animals which are kept together with ovine animals. (10) Delete if the Union is not the final destination of the semen. (11) Mandatory attestation in case antibiotics were added. (12) Insert the name(s) of the antibiotic(s) added and its(their) concentration or the commercial name of the semen diluent containing antibiotic(s). (13) 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. (14) 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. (15) Alternative applicable from 14 April 2024.
Official veterinarian Official veterinarian
Name (in capital letters)
Date Qualification and title
Stamp Signature

CHAPTER 49

MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF STOCKS OF SEMEN OF OVINE AND CAPRINE ANIMALS COLLECTED, PROCESSED AND STORED IN ACCORDANCE WITH COUNCIL DIRECTIVE 92/65/EEC BEFORE 21 APRIL 2021, DISPATCHED AFTER 20 APRIL 2021 FROM THE SEMEN COLLECTION CENTRE WHERE THE SEMEN WAS COLLECTED (MODEL “OV/CAP-SEM-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 OV/CAP-SEM-B-ENTRY Certificate model OV/CAP-SEM-B-ENTRY Certificate model OV/CAP-SEM-B-ENTRY Certificate model OV/CAP-SEM-B-ENTRY
II. Health information II.a Certificate reference II.b IMSOC reference

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