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
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 [ovine] (2) [caprine] (2) animals and listed in Annex X 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, 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] (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, 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] (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 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) [embryos] (2) of [ovine] (2) [caprine] (2) 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 OV/CAP-SEM-A-ENTRY (6);] (2) and/or [Model OV/CAP-SEM-B-ENTRY (6);] (2) and/or [Model OV/CAP-OOCYTES-EMB-A-ENTRY (6);] (2) and/or [Model OV/CAP-OOCYTES-EMB-B-ENTRY (6);] (2) and/or [Model OV/CAP-GP-PROCESSING-ENTRY (6);] (2) and/or [Model OV/CAP-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 ovine and caprine 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/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, 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 and/or embryos were processed and stored, and/or from the germinal product storage centre, where the semen, oocytes and/or embryos were stored, to the germinal product processing establishment 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 : “Type”: Specify if semen, in vivo derived embryos, in vivo derived oocytes, in vitro produced embryos or micromanipulated embryos. “Species”: Indicate “ Ovis aries ” and/or “ Capra hircus ” as appropriate. “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 and/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/ovine/index_en.htm . (2) Delete if not applicable. (3) Only for a third country or territory, or zone thereof with opening date in accordance with column 9 in 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/ovine/index_en.htm. (5) Only a third country or territory, or zone thereof listed in Annex X to Implementing Regulation (EU) 2021/404 and 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 and/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 and/or embryos were processed and stored, and/or from the germinal product storage centre where the semen, oocytes and/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 ovine and/or caprine animals are placed and transported in one container.
Official veterinarian Official veterinarian
Name (in capital letters)
Date Qualification and title
Stamp Signature

CHAPTER 53

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 “OV/CAP-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
--- ---
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-GP-STORAGE-ENTRY Certificate model OV/CAP-GP-STORAGE-ENTRY Certificate model OV/CAP-GP-STORAGE-ENTRY Certificate model OV/CAP-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 [ovine] (2) [caprine] (2) animals and listed in Annex X 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, 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] (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, 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] (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)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) [embryos] (2) of [ovine] (2) [caprine] (2) 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 OV/CAP-SEM-A-ENTRY (6);] (2) and/or [Model OV/CAP-SEM-B-ENTRY (6);] (2) and/or [Model 1 in Section A of Part 2 of Annex II to Decision 2010/472/EU (6);] (2) and/or [Model 2 in Section B of Part 2 of Annex II to Decision 2010/472/EU (6);] (2) and/or [Model OV/CAP-OOCYTES-EMB-A-ENTRY (6);] (2) and/or [Model OV/CAP-OOCYTES-EMB-B-ENTRY (6);] (2) and/or [Model OV/CAP-GP-PROCESSING-ENTRY (6);] (2) and/or [Model OV/CAP-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 ovine and caprine 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 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, 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 and/or embryos were processed and stored, and/or from the germinal product storage centre where the semen, oocytes and/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”: indicate “ Ovis aries ” and/or “ Capra hircus ” 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 or the embryo production team by which oocytes, in vivo derived embryos or in vitro produced 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/ovine/index_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/ovine/index_en.htm. (5) Only a third country or territory, or zone thereof listed in Annex X to Implementing Regulation (EU) 2021/404 and 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 and/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 and/or embryos were processed and stored, and/or from the germinal product storage centre where the semen, oocytes and/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 ovine and/or caprine animals are placed and transported in one container.
Official veterinarian Official veterinarian
Name (in capital letters)
Date Qualification and title
Stamp Signature

CHAPTER 54

MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF SEMEN OF PORCINE 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 “POR-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 POR-SEM-A-ENTRY Certificate model POR-SEM-A-ENTRY Certificate model POR-SEM-A-ENTRY Certificate model POR-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 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 porcine animals and listed in Annex XI 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 its 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 semen and until the date of its dispatch;] (1) either [II.1.3. where classical swine fever was not reported for at least 12 months immediately prior to the date of collection of the semen and until the date of its dispatch;] (1) (2) or [II.1.3. where classical swine fever 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 its dispatch;] II.1.4. where infection with rinderpest virus and African swine fever were not reported for at least 12 months immediately prior to the date of collection of the semen and until the date of its dispatch; II.1.5. where no vaccination against infection with rinderpest virus and classical swine fever has been carried out for at least 12 months immediately prior to the date of collection of the semen and until the date of its 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.] 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 the preceding 30 days and in which foot and mouth disease has not been reported during at least the preceding 3 months, (1) either [in which they were not vaccinated against foot and mouth disease;] (1) or [in which they were vaccinated against foot and mouth disease during 12 months immediately 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 in which 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. which are free from infection with Brucella abortus, B. melitensis and B. suis in accordance with the requirements laid down in Part 5, Chapter IV, of Annex II to Commission Delegated Regulation (EU) 2020/686; II.2.3. where no clinical, serological, virological or pathological evidence of infection with Aujeszky’s disease virus had been detected during at least the preceding 12 months; II.2.4. where, during at least 3 months immediately prior to the date of entry into the quarantine accommodation, no animal was vaccinated against infection with porcine reproductive and respiratory syndrome virus and no infection with porcine reproductive and respiratory syndrome virus was detected. II.3. The semen described in Part I has been collected, processed and stored, and dispatched from the semen collection centre (3) 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, classical swine fever and infection with porcine reproductive and respiratory syndrome virus; II.4.2. remained for at least 3 months immediately 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 day of their admission to a semen collection centre and on the day 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 immediately 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, classical swine fever or African swine fever, or of an emerging disease relevant for porcine animals; II.4.5.2. were kept in a single establishment where infection with Brucella abortus, B. melitensis and B. suis, infection with rabies virus, anthrax, infection with Aujeszky’s disease virus and infection with porcine reproductive and respiratory syndrome virus 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 quarantine accommodation, where only other cloven-hoofed animals with at least the same health status were present, which on the day 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 the preceding 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 the preceding 30 days; II.4.6.4. has had no outbreak of foot and mouth disease reported during at least 3 months immediately preceding the date of admission of the animals to the semen collection centre; II.4.6.5. it was free from infection with Brucella abortus, Brucella melitensis and Brucella suis for at least the preceding 3 months; II.4.7. were kept in semen collection centres: II.4.7.1. which were 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 immediately prior to the date of collection of the semen, and (1) (4) either [at least 30 days following the date of the collection;] (1) (5) or [until the date of dispatch of the consignment of semen 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 centres for at least the preceding 30 days; and (1) (4) either [were free from foot and mouth disease for at least 3 months immediately prior to the date of collection of the semen and 30 days from the date of collection;] (1) (5) or [were free from foot and mouth disease for at least 3 months immediately prior to the date of collection of the semen and until the date of dispatch of the consignment of semen to the Union and they have been kept at that semen collection centre for at least 30 days immediately prior to the date of collection of the semen;] II.4.7.4. where no clinical, serological, virological or pathological evidence of infection with Aujeszky’s disease virus had been reported for a period comprising at least 30 days immediately prior to the date of admission and at least 30 days immediately prior to the date of collection of the semen; II.4.8. have been subjected to the following tests, carried out within 30 days immediately prior to the date of commencement of the quarantine referred to in point II.4.6, with negative results, required in accordance with Part 2, Chapter I, point 1(b), of Annex II to Delegated Regulation (EU) 2020/686: II.4.8.1. as regards infection with Brucella abortus, B. melitensis and B. suis, a buffered Brucella antigen test (rose Bengal test), a competitive ELISA or an indirect ELISA for the detection of antibodies to smooth Brucella species; II.4.8.2. as regards infection with Aujeszky’s disease virus, (1) either [in the case of non-vaccinated animals, an ELISA to detect antibodies to the whole Aujeszky’s disease virus or to glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) of the virus or a serum neutralisation test;] (1) or [in the case of animals vaccinated with a gE deleted vaccine, an ELISA to detect antibodies to glycoprotein E (ADV-gE) of Aujeszky’s disease virus;] (1) [II.4.8.3. as regards classical swine fever, an antibody ELISA or serum neutralisation test, in the case of animals coming from a third country or territory, or zone thereof where classical swine fever has been reported or vaccination against this disease has been practised for the preceding 12 months;] II.4.8.4. as regards infection with porcine reproductive and respiratory syndrome virus, a serological test (the immunoperoxidase monolayer assay (IPMA), immunofluorescence assay (IFA), or ELISA); II.4.9. 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 2, Chapter I, point 1(c), of Annex II to Delegated Regulation (EU) 2020/686: II.4.9.1. as regards infection with Brucella abortus, B. melitensis and B. suis, a buffered Brucella antigen test (rose Bengal test), a competitive ELISA or an indirect ELISA for the detection of antibodies to smooth Brucella species; II.4.9.2. as regards infection with Aujeszky’s disease virus (1) either [in the case of non-vaccinated animals, an ELISA to detect antibodies to the whole Aujeszky’s disease virus or to glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) of the virus or a serum neutralisation test;] (1) or [in the case of animals vaccinated with a gE deleted vaccine, an ELISA to detect antibodies to glycoprotein E (ADV-gE) of Aujeszky’s disease virus;] II.4.9.3. as regards infection with porcine reproductive and respiratory syndrome virus, a serological test (IPMA, IFA, or ELISA) and a test for virus genome (reverse-transcription polymerase chain reaction (RT-PCR), nested set RT-PCR, real-time RT-PCR); II.4.10. have been subjected, at semen collection centre, to the following compulsory routine tests, required in accordance with Part 2, Chapter I, point 2(a), of Annex II to Delegated Regulation (EU) 2020/686: II.4.10.1. as regards infection with Brucella abortus, B. melitensis and B. suis, a buffered Brucella antigen test (rose Bengal test), a competitive ELISA or an indirect ELISA for the detection of antibodies to smooth Brucella species; II.4.10.2. as regards infection with Aujeszky’s disease virus (1) either [in the case of non-vaccinated animals, an ELISA to detect antibodies to the whole Aujeszky’s disease virus or to glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) of the virus or a serum neutralisation test;] (1) or [in the case of animals vaccinated with a gE deleted vaccine, an ELISA to detect antibodies to glycoprotein E (ADV-gE) of Aujeszky’s disease virus;] (1) [II.4.10.3. as regards classical swine fever, an antibody ELISA or serum neutralisation test, in the case of animals coming from a third country or territory, or zone thereof where classical swine fever has been reported or vaccination against this disease has been practised for the preceding 12 months;] II.4.10.4. as regards infection with porcine reproductive and respiratory syndrome virus, a serological test (IPMA, IFA, or ELISA); II.4.11. have been subjected to the tests referred to in point II.4.10 carried out, in accordance with Part 2, Chapter I, point 2(b), of Annex II to Delegated Regulation (EU) 2020/686, on samples taken from (1) either [all animals immediately prior to the date of dispatch from the semen collection centre, or upon the date of arrival at the slaughterhouse, and in no case later than 12 months from the date of admission to the semen collection centre.] (1) or [at least 25% of the animals in the semen collection centre every 3 months to test for infection with Brucella abortus, Brucella melitensis and Brucella suis, infection with Aujeszky’s disease virus and classical swine fever, and at least 10% of the animals in the semen collection centre every month to test for infection with porcine reproductive and respiratory syndrome virus.] (1) or [at least 10% of the animals in the semen collection centre every month to test for infection with Brucella abortus, Brucella melitensis and Brucella suis, infection with Aujeszky’s disease virus, classical swine fever and infection with porcine reproductive and respiratory syndrome virus.] II.5. The semen 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) (4) [II.5.3.3. has been filled in with a cryogenic agent which has not been previously used for other products.] (1) [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: … ; (6) 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 15 °C for not less than 45 minutes, or under a time-temperature regime with a documented equivalent bactericidal activity.] Notes “Porcine animal” means a porcine animal as defined in Article 2, point (4), of Delegated Regulation (EU) 2020/686. This animal health certificate is intended for the entry into the Union of semen of porcine 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: https://ec.europa.eu/food/animals/semen/porcine_en. 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 : “Type”: indicate semen. “Identification number”: Indicate identification number of each donor animal. “Identification mark”: Indicate 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 number of straws or other packages with the same mark. 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 semen collection centres listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: https://ec.europa.eu/food/animals/semen/porcine_en. (4) Applicable for frozen semen. (5) Applicable for fresh and chilled semen. (6) Insert the name(s) of the antibiotic(s) added and its (their) concentration or the commercial name of the semen diluent containing antibiotic(s).
Official veterinarian Official veterinarian
Name (in capital letters)
Date Qualification and title
Stamp Signature

CHAPTER 55

MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF STOCKS OF SEMEN OF PORCINE ANIMALS COLLECTED, PROCESSED AND STORED IN ACCORDANCE WITH COUNCIL DIRECTIVE 90/429/EEC BEFORE 21 APRIL 2021, DISPATCHED AFTER 20 APRIL 2021 FROM THE SEMEN COLLECTION CENTRE WHERE THE SEMEN WAS COLLECTED (MODEL “POR-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 POR-SEM-B-ENTRY Certificate model POR-SEM-B-ENTRY Certificate model POR-SEM-B-ENTRY Certificate model POR-SEM-B-ENTRY
II. Health information II.a Certificate reference II.b IMSOC reference

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