Legalize / European Union / Implementing Regulation

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

Type Implementing Regulation

Publication 2025-04-22

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

articles 3

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

Reform history JSON API


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 equine animals and listed in Annex XII to Commission Implementing Regulation (EU) 2021/404; II.1.1.2. free from African horse sickness 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 in accordance with Article 22(2), point (a), of Commission Delegated Regulation (EU) 2020/692, and where no systematic vaccination against African horse sickness has been carried out for at least 12 months immediately prior to the date of collection of the [semen] ⁽²⁾ [oocytes] ⁽²⁾ [embryos] ⁽²⁾ and until the date of its/their dispatch in accordance with Article 22(4), point (b), of that Regulation; II.1.1.3. where Venezuelan equine encephalomyelitis 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; II.1.2. is an establishment: ⁽²⁾ either [II.1.2.1. where infection with Burkholderia mallei (glanders) was not reported for at least 36 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⁾ or [II.1.2.1. where infection with Burkholderia mallei (glanders) was not reported for at least 6 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 the Commission has recognised the surveillance programme carried out in breeding equine animals in the establishment of origin to demonstrate absence of infection during that period;] ⁽²⁾ either [II.1.2.2. where dourine 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⁾ or [II.1.2.2. where dourine was not reported for at least 6 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 the Commission has recognised the surveillance programme carried out in breeding equine animals in the establishment of origin to demonstrate absence of infection during that period;] ⁽²⁾ either [II.1.2.3. where surra (Trypanosoma evansi) 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⁾ or [II.1.2.3. where surra (Trypanosoma evansi) was not reported for at least 6 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 the Commission has recognised the surveillance programme carried out in breeding equine animals in the establishment of origin to demonstrate absence of infection during that period;] II.1.3. is approved and listed by the competent authority of the third country or territory; II.1.4. 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) (3)} [by an embryo collection team] ^{(2) (3)} [by an embryo production team] ^{(2) (3)} [and] ⁽²⁾ [processed] ⁽²⁾ [stored] ⁽²⁾ [in a germinal product processing establishment] ^{(2) (3)} and stored in a germinal product storage centre ⁽³⁾ complying with requirements as regards responsibilities, operational procedures, facilities and equipment 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, or zone thereof of dispatch to the Union ⁽⁴⁾;] ^{(2) (4)} and/or [located in …, and has/have been introduced into the third country or territory, or zone thereof 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 equine animals in accordance with Regulation (EU) 2016/429 and 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 EQUI-SEM-A-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-SEM-B-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-SEM-C-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-SEM-D-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-OOCYTES-EMB-A-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-OOCYTES-EMB-B-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-OOCYTES-EMB-C-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-GP-PROCESSING-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-GP-STORAGE-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model 1 in Section A of Part 1 of Annex III to Implementing Regulation (EU) 2018/659 ⁽⁵⁾;] ⁽²⁾ and/or [Model 2 in Section B of Part 1 of Annex III to Implementing Regulation (EU) 2018/659 ⁽⁵⁾;] ⁽²⁾ and/or [Model 3 in Section C of Part 1 of Annex III to Implementing Regulation (EU) 2018/659 ⁽⁵⁾;] ⁽²⁾ and/or [Model 4 in Section D of Part 1 of Annex III to Implementing Regulation (EU) 2018/659 ⁽⁵⁾;] ⁽²⁾ and/or [Model 1 in Section A of Part 2 of Annex II to Decision 2010/471/EU ⁽⁵⁾;] ⁽²⁾ and/or [Model 2 in Section B of Part 2 of Annex II to Decision 2010/471/EU ⁽⁵⁾;] ⁽²⁾ and/or [Model 3 in Section C of Part 2 of Annex II to Decision 2010/471/EU ⁽⁵⁾;] ⁽²⁾ and/or [Model in Annex to Commission Decision 96/539/EC ⁽⁵⁾;] 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) (6)} [II.2.5.3. has been filled in with a cryogenic agent which has not been previously used for other products.] ^{(2) (7)} [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 equine 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: https://ec.europa.eu/food/animals/semen/equine_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, 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 : “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 the embryo collection team and/or 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: https://ec.europa.eu/food/animals/semen/equine_en ⁽²⁾ Delete if not applicable. ⁽³⁾ Only approved germinal product establishments listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: https://ec.europa.eu/food/animals/semen/equine_en. ⁽⁴⁾ Only a third country or territory, or zone thereof listed in Part 1 of Annex XII to Implementing Regulation (EU) 2021/404 and Member States. ⁽⁵⁾ 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 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 of dispatch of the semen, oocytes and/or embryos described in box I.11 shall be attached to this animal health certificate. ⁽⁶⁾ Applicable for frozen semen, oocytes or embryos. ⁽⁷⁾ Applicable for consignments where semen, oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of equine animals are placed and transported in one container.

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 equine animals and listed in Annex XII to Commission Implementing Regulation (EU) 2021/404; II.1.1.2. free from African horse sickness 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 in accordance with Article 22(2), point (a), of Commission Delegated Regulation (EU) 2020/692, and where no systematic vaccination against African horse sickness has been carried out for at least 12 months immediately prior to the date of collection of the [semen] ⁽²⁾ [oocytes] ⁽²⁾ [embryos] ⁽²⁾ and until the date of its/their dispatch in accordance with Article 22(4), point (b), of that Regulation; II.1.1.3. where Venezuelan equine encephalomyelitis 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; II.1.2. is an establishment: ⁽²⁾ either [II.1.2.1. where infection with Burkholderia mallei (glanders) was not reported for at least 36 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⁾ or [II.1.2.1. where infection with Burkholderia mallei (glanders) was not reported for at least 6 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 the Commission has recognised the surveillance programme carried out in breeding equine animals in the establishment of origin to demonstrate absence of infection during that period;] ⁽²⁾ either [II.1.2.2. where dourine 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⁾ or [II.1.2.2. where dourine was not reported for at least 6 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 the Commission has recognised the surveillance programme carried out in breeding equine animals in the establishment of origin to demonstrate absence of infection during that period;] ⁽²⁾ either [II.1.2.3. where surra (Trypanosoma evansi) 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⁾ or [II.1.2.3. where surra (Trypanosoma evansi) was not reported for at least 6 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 the Commission has recognised the surveillance programme carried out in breeding equine animals in the establishment of origin to demonstrate absence of infection during that period;] II.1.3. is approved and listed by the competent authority of the third country or territory; II.1.4. 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) (3)} [by an embryo collection team] ^{(2) (3)} [by an embryo production team] ^{(2) (3)} [and] ⁽²⁾ [processed] ⁽²⁾ [stored] ⁽²⁾ [in a germinal product processing establishment] ^{(2) (3)} and stored in a germinal product storage centre ⁽³⁾ complying with requirements as regards responsibilities, operational procedures, facilities and equipment 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, or zone thereof of dispatch to the Union ⁽⁴⁾;] ^{(2) (4)} and/or [located in …, and has/have been introduced into the third country or territory, or zone thereof 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 equine animals in accordance with Regulation (EU) 2016/429 and 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 EQUI-SEM-A-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-SEM-B-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-SEM-C-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-SEM-D-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-OOCYTES-EMB-A-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-OOCYTES-EMB-B-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-OOCYTES-EMB-C-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-GP-PROCESSING-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model EQUI-GP-STORAGE-ENTRY ⁽⁵⁾;] ⁽²⁾ and/or [Model 1 in Section A of Part 1 of Annex III to Implementing Regulation (EU) 2018/659 ⁽⁵⁾;] ⁽²⁾ and/or [Model 2 in Section B of Part 1 of Annex III to Implementing Regulation (EU) 2018/659 ⁽⁵⁾;] ⁽²⁾ and/or [Model 3 in Section C of Part 1 of Annex III to Implementing Regulation (EU) 2018/659 ⁽⁵⁾;] ⁽²⁾ and/or [Model 4 in Section D of Part 1 of Annex III to Implementing Regulation (EU) 2018/659 ⁽⁵⁾;] ⁽²⁾ and/or [Model 1 in Section A of Part 2 of Annex II to Decision 2010/471/EU ⁽⁵⁾;] ⁽²⁾ and/or [Model 2 in Section B of Part 2 of Annex II to Decision 2010/471/EU ⁽⁵⁾;] ⁽²⁾ and/or [Model 3 in Section C of Part 2 of Annex II to Decision 2010/471/EU ⁽⁵⁾;] ⁽²⁾ and/or [Model in Annex to Commission Decision 96/539/EC ⁽⁵⁾;] 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) (6)} [II.2.5.3. has been filled in with a cryogenic agent which has not been previously used for other products.] ^{(2) (7)} [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 equine 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: https://ec.europa.eu/food/animals/semen/equine_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, 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 : “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 the embryo collection team and/or 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: https://ec.europa.eu/food/animals/semen/equine_en ⁽²⁾ Delete if not applicable. ⁽³⁾ Only approved germinal product establishments listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: https://ec.europa.eu/food/animals/semen/equine_en. ⁽⁴⁾ Only a third country or territory, or zone thereof listed in Part 1 of Annex XII to Implementing Regulation (EU) 2021/404 and Member States. ⁽⁵⁾ 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 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 of dispatch of the semen, oocytes and/or embryos described in box I.11 shall be attached to this animal health certificate. ⁽⁶⁾ Applicable for frozen semen, oocytes or embryos. ⁽⁷⁾ Applicable for consignments where semen, oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of equine animals are placed and transported in one container.


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

CHAPTER 68 MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF SEMEN, OOCYTES AND EMBRYOS OF TERRESTRIAL ANIMALS KEPT AT CONFINED ESTABLISHMENTS WHICH WERE COLLECTED OR PRODUCED, 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 (MODEL “GP-CONFINED-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 GP-CONFINED-ENTRY	Certificate model GP-CONFINED-ENTRY	Certificate model GP-CONFINED-ENTRY	Certificate model GP-CONFINED-ENTRY
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference


I, the undersigned official veterinarian, hereby certify, that: II.1. The [semen] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ [oocytes] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ described in Part I is/are intended for artificial reproduction and was/were obtained from donor animals which: II.1.1. originate from a third country or territory, or zone thereof authorised for the entry into the Union of the particular species and category of animals and listed in Annexes II to VII to Commission Implementing Regulation (EU) 2021/404, or authorised pursuant to Article 230(2) of Regulation (EU) 2016/429 by the Member State of destination, depending on the species in question; II.1.2. originate from a confined establishment in the third country or territory, or zone thereof of origin, which is included in a list of confined establishments, established by the Member State of destination in accordance with Article 117, point (c), of Commission Delegated Regulation (EU) 2020/692, from which the entry of animals of specific species into the Union may be authorised; II.1.3. do not come from an establishment, nor have been in contact with animals from an establishment, situated in a restricted zone established due to the occurrence of a category A disease referred to in the Annex to Commission Implementing Regulation (EU) 2018/1882, or of an emerging disease relevant for species of those kept terrestrial animals; II.1.4. come from an establishment where no category D disease, relevant for species of those kept terrestrial animals as referred to in the Annex to Implementing Regulation (EU) 2018/1882, has been reported for at least 30 days immediately prior to the date of collection of the [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾intended for entry into the Union; II.1.5. have remained in a single confined establishment of origin for at least 30 days immediately prior to the date of collection of the [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾intended for entry into the Union; ^{(1) (2)} either [II.1.6. are bovine, porcine, ovine, caprine or equine animals and are identified in accordance with Article 21 of Delegated Regulation (EU) 2020/692;] ^{(1) (3)} or [II.1.6. are terrestrial animals other than bovine, porcine, ovine, caprine or equine animals and are identified and registered in accordance with the rules of the confined establishment;] II.1.7. have been clinically examined by the establishment veterinarian responsible for the activities carried out at the confined establishment and showed no disease symptoms on the date of collection of the [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; II.1.8. as much as possible, were not used for natural breeding for at least 30 days immediately prior to the date of collection of the [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾and during the collection period. II.2. The [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I: II.2.1. is/are placed in straws or other packages on which the mark is applied in accordance with requirements provided for in ^{(1) (2)} [Article 83, point (a), of Delegated Regulation (EU) 2020/692 and that mark is indicated in box I.27;] ^{(1) (3)} [Article 119, point (a), of Delegated Regulation (EU) 2020/692 and that mark is indicated in box I.27;] II.2.2. is/are placed in a transport container which: II.2.2.1. was sealed and numbered prior to the date of dispatch from the confined establishment by the establishment veterinarian responsible for the activities of the confined establishment and the seal bears the number as indicated in box I.19; II.2.2.2. has been cleaned and either disinfected or sterilised before use, or is a single-use container; ^{(1) (4)} [II.2.2.3. has been filled in with a cryogenic agent which has not been previously used for other products.] ^{(1) (2) (5)} [II.2.3. is/are placed in straws or other packages which are securely and hermetically sealed; II.2.4. 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.] II.3. The consignment of [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ II.3.1. is destined to a confined establishment in the Union, which is approved in accordance with Article 95 of Regulation (EU) 2016/429; II.3.2. is transported directly to the confined establishment as indicated in box I.12. Notes This animal health certificate is intended for the entry into the Union of semen, oocytes and embryos of terrestrial animals kept at confined establishments, 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, if assigned by the competent authority, and the name and address of the confined establishment of dispatch of the consignment of semen, oocytes or embryos. Box reference I.12 : “Place of destination”: Indicate the name, address and unique approval number of the confined establishment of destination in the Union of the consignment of semen, oocytes or embryos. Box reference I.27 : “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 or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which semen, oocytes or embryos of the consignment was/were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number, if assigned by the competent authority, and the name and address of the confined establishment of the collection or production of semen, oocytes or embryos of the consignment. “Quantity”: Indicate number of straws or other packages with the same mark. Part II: ⁽¹⁾ Delete if not applicable. ⁽²⁾ Applicable for consignments of semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals. ⁽³⁾ Applicable for consignments of semen, oocytes or embryos of terrestrial animals other than bovine, porcine, ovine, caprine or equine animals. ⁽⁴⁾ Applicable for frozen semen, oocytes or embryos. ⁽⁵⁾ Applicable for consignments where oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of bovine, porcine, ovine, caprine or equine animals are placed and transported in one container.

I, the undersigned official veterinarian, hereby certify, that: II.1. The [semen] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ [oocytes] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ described in Part I is/are intended for artificial reproduction and was/were obtained from donor animals which: II.1.1. originate from a third country or territory, or zone thereof authorised for the entry into the Union of the particular species and category of animals and listed in Annexes II to VII to Commission Implementing Regulation (EU) 2021/404, or authorised pursuant to Article 230(2) of Regulation (EU) 2016/429 by the Member State of destination, depending on the species in question; II.1.2. originate from a confined establishment in the third country or territory, or zone thereof of origin, which is included in a list of confined establishments, established by the Member State of destination in accordance with Article 117, point (c), of Commission Delegated Regulation (EU) 2020/692, from which the entry of animals of specific species into the Union may be authorised; II.1.3. do not come from an establishment, nor have been in contact with animals from an establishment, situated in a restricted zone established due to the occurrence of a category A disease referred to in the Annex to Commission Implementing Regulation (EU) 2018/1882, or of an emerging disease relevant for species of those kept terrestrial animals; II.1.4. come from an establishment where no category D disease, relevant for species of those kept terrestrial animals as referred to in the Annex to Implementing Regulation (EU) 2018/1882, has been reported for at least 30 days immediately prior to the date of collection of the [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾intended for entry into the Union; II.1.5. have remained in a single confined establishment of origin for at least 30 days immediately prior to the date of collection of the [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾intended for entry into the Union; ^{(1) (2)} either [II.1.6. are bovine, porcine, ovine, caprine or equine animals and are identified in accordance with Article 21 of Delegated Regulation (EU) 2020/692;] ^{(1) (3)} or [II.1.6. are terrestrial animals other than bovine, porcine, ovine, caprine or equine animals and are identified and registered in accordance with the rules of the confined establishment;] II.1.7. have been clinically examined by the establishment veterinarian responsible for the activities carried out at the confined establishment and showed no disease symptoms on the date of collection of the [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; II.1.8. as much as possible, were not used for natural breeding for at least 30 days immediately prior to the date of collection of the [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾and during the collection period. II.2. The [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I: II.2.1. is/are placed in straws or other packages on which the mark is applied in accordance with requirements provided for in ^{(1) (2)} [Article 83, point (a), of Delegated Regulation (EU) 2020/692 and that mark is indicated in box I.27;] ^{(1) (3)} [Article 119, point (a), of Delegated Regulation (EU) 2020/692 and that mark is indicated in box I.27;] II.2.2. is/are placed in a transport container which: II.2.2.1. was sealed and numbered prior to the date of dispatch from the confined establishment by the establishment veterinarian responsible for the activities of the confined establishment and the seal bears the number as indicated in box I.19; II.2.2.2. has been cleaned and either disinfected or sterilised before use, or is a single-use container; ^{(1) (4)} [II.2.2.3. has been filled in with a cryogenic agent which has not been previously used for other products.] ^{(1) (2) (5)} [II.2.3. is/are placed in straws or other packages which are securely and hermetically sealed; II.2.4. 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.] II.3. The consignment of [semen] ⁽¹⁾ [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ II.3.1. is destined to a confined establishment in the Union, which is approved in accordance with Article 95 of Regulation (EU) 2016/429; II.3.2. is transported directly to the confined establishment as indicated in box I.12. Notes This animal health certificate is intended for the entry into the Union of semen, oocytes and embryos of terrestrial animals kept at confined establishments, 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, if assigned by the competent authority, and the name and address of the confined establishment of dispatch of the consignment of semen, oocytes or embryos. Box reference I.12 : “Place of destination”: Indicate the name, address and unique approval number of the confined establishment of destination in the Union of the consignment of semen, oocytes or embryos. Box reference I.27 : “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 or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which semen, oocytes or embryos of the consignment was/were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number, if assigned by the competent authority, and the name and address of the confined establishment of the collection or production of semen, oocytes or embryos of the consignment. “Quantity”: Indicate number of straws or other packages with the same mark. Part II: ⁽¹⁾ Delete if not applicable. ⁽²⁾ Applicable for consignments of semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals. ⁽³⁾ Applicable for consignments of semen, oocytes or embryos of terrestrial animals other than bovine, porcine, ovine, caprine or equine animals. ⁽⁴⁾ Applicable for frozen semen, oocytes or embryos. ⁽⁵⁾ Applicable for consignments where oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of bovine, porcine, ovine, caprine or equine animals are placed and transported in one container.


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

’.

ELI: http://data.europa.eu/eli/reg_impl/2025/544/oj

ISSN 1977-0677 (electronic edition)

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.