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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 exporting country … (name of exporting country) ⁽¹⁾ ⁽²⁾ either [II.1.1. has during the past 12 months been free of foot-and-mouth disease, classical swine fever and African swine fever, and that no vaccinations have been carried out against any of these diseases during the past 12 months;] ⁽²⁾ or [II.1.1. is recognised as free of foot-and-mouth disease without vaccination by the World Organisation for Animal Health (OIE) and free of classical swine fever and African swine fever, in accordance with the recommendations laid down in the OIE Terrestrial Animal Health Code;] II.2. the semen collection centre ⁽³⁾ in which the semen in this consignment was collected: II.2.1. was approved for export to the Union by the veterinary services of … (name of third country ⁽²⁾) and complied on date of collection with the conditions for approval and supervision set out in Chapter I and Chapter II of Annex A to Directive 90/429/EEC; II.2.2. was, during the period commencing 3 months prior to the date of collection of the semen in this consignment until the date of its dispatch, situated in an area not restricted due to an outbreak of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, and vesicular stomatitis; II.2.3. was, during the period commencing 30 days prior to the date of collection of the semen in this consignment until the date of its dispatch, free from brucellosis and Aujeszky's disease; ⁽²⁾ either [II.2.4. contained only animals that have not been vaccinated against Aujeszky's disease and met the requirements of Annex B to Directive 90/429/EEC.] ^{(2) (4)} and/or [II.2.4. was a centre in which some or all of the animals have been vaccinated against Aujeszky's disease using a gE deleted vaccine and met the requirements of Annex B to Directive 90/429/EEC.] Conditions for the admission of animals to the semen collection centre II.3. Prior to be admitted to the semen collection centre, all animals: II.3.1. were subjected to a period of quarantine of at least 30 days in accommodation specifically approved for the purpose by the competent authority, and where only animals having at least the same health status were present (quarantine accommodation); II.3.2. prior to entering the quarantine accommodation, were chosen from herds or holdings: II.3.2.1. which were free of brucellosis in accordance with the Chapter on porcine brucellosis of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE); II.3.2.2. in which no animal vaccinated against foot and-mouth disease was present in the preceding 12 months; II.3.2.3. which were not situated in a restricted area defined under the provisions of the national legislation due to an outbreak of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease; II.3.2.4. in which no clinical, serological, virological or pathological evidence of Aujeszky's disease was detected in the preceding 12 months; II.3.3. prior to entering the quarantine accommodation, were not previously kept in any herd of a lower health status than described in II.3.2.; II.3.4. within 30 days prior to entering the quarantine accommodation referred to in point II.3.1, were subjected to the following tests, performed in accordance with international standards, with negative results: II.3.4.1. as regards brucellosis, a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA; II.3.4.2. as regards Aujeszky’s disease, ⁽²⁾ either [II.3.4.2.1. in the case of non-vaccinated animals, a serum neutralisation test or an ELISA for detecting antibodies to the whole Aujeszky’s disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD);] ⁽²⁾ or [II.3.4.2.1. in the case of animals vaccinated with a gE deleted vaccine, an ELISA for detecting antibodies to glycoprotein E (ADV-gE);] ⁽²⁾ either [II.3.5. were admitted to the centre after all of the animals had reacted with negative result to a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA carried out on samples collected during the last 15 days of the period of quarantine specified in point II.3.1;] ⁽²⁾ or [II.3.5. were admitted to the centre after not all of the animals had reacted with negative result to a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA carried out on samples collected during the last 15 days of the period of quarantine specified in point II.3.1 and the suspicion of brucellosis was ruled out in accordance with point 1.5. of Chapter I of Annex B to Directive 90/429/EEC;] II.3.6. were subjected to the following tests for Aujeszky's disease carried out on samples collected during the last 15 days of the period of quarantine specified in point II.3.1: ⁽²⁾ either [II.3.6.1. in the case of non-vaccinated animals, a serum neutralisation test or an ELISA for detecting antibodies to the whole Aujeszky’s disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD);] ⁽²⁾ or [II.3.6.1. in the case of animals vaccinated with a gE deleted vaccine, an ELISA for detecting antibodies to glycoprotein E (ADV-gE);] ⁽²⁾ either [II.3.6.2. the tests referred to in point II.3.6.1 were carried out with negative result in each case;] ⁽²⁾ or [II.3.6.2. the animals that proved positive in a test referred to in point II.3.6.1 were removed immediately from the quarantine accommodation and the competent authority took all necessary measures to ensure that the remaining animals had a satisfactory health status before being admitted to the collection centre in accordance with point II.3;] II.3.7. All tests were carried out in a laboratory approved by the competent authority; II.3.8. Animals were only admitted to the semen collection centre with the express permission of the centre veterinarian and all animal movements, entering and exiting the semen collection centre, are recorded; II.3.9. No animal admitted to the semen collection centre showed any clinical sign of disease on the day of admission; all animals came directly from the quarantine accommodation which, on the day of consignment and during the period of residency of the animals, officially fulfilled the following conditions: II.3.9.1. it was not situated in a restricted area defined under the provisions of national legislation due to an outbreak of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease; II.3.9.2. no clinical, serological, virological or pathological evidence of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease had been recorded for the past 30 days. Compulsory routine tests for animals kept at the semen collection centre II.4. All animals kept at the semen collection centre are subjected to the following routine tests carried out in a laboratory approved by the competent authority: II.4.1. as regards brucellosis, a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA; II.4.2. as regards Aujeszky’s disease virus, ⁽¹⁾ either [II.4.2.1. in the case of non-vaccinated animals, a serum neutralisation test or an ELISA for detecting antibodies to the whole Aujeszky’s disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD).] ⁽¹⁾ or [II.4.2.1. in the case of animals vaccinated with a gE deleted vaccine, an ELISA for detecting antibodies to glycoprotein E (ADV-gE).] II.4.3. The routine tests referred to in points II.4.1 and II.4.2 are carried out on samples taken in accordance with point 1.2. of Chapter II of Annex B to Directive 90/429/EEC in order to ensure that all animals in the centre have been tested at least once during their stay at that centre and at least every 12 months from the date of admission, if their stay exceeds 12 months; ⁽²⁾ either [II.4.4. All of the animals have reacted with negative results in the routine tests referred to in points II.4.1 and II.4.2 carried out on samples referred to in point II.4.3.] ⁽²⁾ or [II.4.4. Not all of the animals have reacted with negative results in the tests referred to in points II.4.1 and II.4.2., which were carried out on samples referred to in point II.4.3: (a) the animals which proved positive were isolated, (b) the semen collected from each animal at the centre since the date of that animal's last negative test was held in separate storage from semen eligible for export to the European Union which was collected before the animal's last negative test or after the health status of the centre had been re-established under responsibility of the competent authority of the exporting country.] Conditions for semen collected at a semen collection centre and intended for export to the Union II.5. The semen in this consignment was obtained from animals which: II.5.1. have been resident in … (name of third country ⁽¹⁾) for a minimum period of 3 months immediately prior to collection; II.5.2. showed no clinical signs of disease on the day the semen was collected; II.5.3. had not been vaccinated against foot-and-mouth disease; II.5.4. satisfy the requirements referred to in point II.3; II.5.5. have not been allowed to serve naturally; II.5.6. were kept in semen collection centres which were not situated in a restricted area designated under the provisions of the national legislation relating to foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease; II.5.7. were kept in semen collection centres in which no clinical, serological, virological or pathological evidence of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease has been detected in the 30-day period immediately prior to collection. II.6. An effective combination of antibiotics, in particular against leptospires, was added to the semen in this consignment after final dilution or to the diluent. In the case of frozen semen, antibiotics were added before the semen was frozen. II.6.1. The combination of antibiotics referred to in point II.6 produced an effect at least equivalent to the following concentration in the final diluted semen: (a) not less than 500 μg streptomycin per ml final dilution, (b) not less than 500 IU penicillin per ml final dilution, (c) not less than 150 μg lincomycin per ml final dilution, (d) not less than 300 μg spectinomycin per ml final dilution; II.6.2. Immediately after the addition of the antibiotics the diluted semen was kept at a temperature of at least 15 °C for a period of not less than 45 minutes. II.7. The semen in this consignment: II.7.1. has been stored as laid down in point 2(d) of Chapter I and point 6(a), (b), (e) and (f) of Chapter II of Annex A to Directive 90/429/EEC prior to dispatch; II.7.2. is being transported to the country of destination in flasks which were cleaned and disinfected or sterilised before use and which have been sealed prior to dispatch from the approved storage facilities. 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 to the Union. Only semen collection centre listed in accordance with Article 8(2) of Directive 90/429/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/porcine/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. 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 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. Part II: ⁽¹⁾ Only third country or territory, or zone thereof listed in Annex XI to Commission Implementing Regulation (EU) 2021/404 for semen of porcine animals. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only semen collection centres listed in accordance with Article 8(2) of Directive 90/429/EEC on the Commission website: https://ec.europa.eu/food/animals/semen/porcine_en. ⁽⁴⁾ This option shall be deleted in case the Member State or region thereof of destination is free of Aujeszky’s disease in accordance with Article 10 of Directive 64/432/EEC, has informed the Commission in accordance with point 4 of Annex C to Directive 90/429/EEC and is listed on the following Commission website: https://ec.europa.eu/food/animals/semen/porcine_en.

I, the undersigned, official veterinarian, hereby certify that: II.1. the exporting country … (name of exporting country) ⁽¹⁾ ⁽²⁾ either [II.1.1. has during the past 12 months been free of foot-and-mouth disease, classical swine fever and African swine fever, and that no vaccinations have been carried out against any of these diseases during the past 12 months;] ⁽²⁾ or [II.1.1. is recognised as free of foot-and-mouth disease without vaccination by the World Organisation for Animal Health (OIE) and free of classical swine fever and African swine fever, in accordance with the recommendations laid down in the OIE Terrestrial Animal Health Code;] II.2. the semen collection centre ⁽³⁾ in which the semen in this consignment was collected: II.2.1. was approved for export to the Union by the veterinary services of … (name of third country ⁽²⁾) and complied on date of collection with the conditions for approval and supervision set out in Chapter I and Chapter II of Annex A to Directive 90/429/EEC; II.2.2. was, during the period commencing 3 months prior to the date of collection of the semen in this consignment until the date of its dispatch, situated in an area not restricted due to an outbreak of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, and vesicular stomatitis; II.2.3. was, during the period commencing 30 days prior to the date of collection of the semen in this consignment until the date of its dispatch, free from brucellosis and Aujeszky's disease; ⁽²⁾ either [II.2.4. contained only animals that have not been vaccinated against Aujeszky's disease and met the requirements of Annex B to Directive 90/429/EEC.] ^{(2) (4)} and/or [II.2.4. was a centre in which some or all of the animals have been vaccinated against Aujeszky's disease using a gE deleted vaccine and met the requirements of Annex B to Directive 90/429/EEC.] Conditions for the admission of animals to the semen collection centre II.3. Prior to be admitted to the semen collection centre, all animals: II.3.1. were subjected to a period of quarantine of at least 30 days in accommodation specifically approved for the purpose by the competent authority, and where only animals having at least the same health status were present (quarantine accommodation); II.3.2. prior to entering the quarantine accommodation, were chosen from herds or holdings: II.3.2.1. which were free of brucellosis in accordance with the Chapter on porcine brucellosis of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE); II.3.2.2. in which no animal vaccinated against foot and-mouth disease was present in the preceding 12 months; II.3.2.3. which were not situated in a restricted area defined under the provisions of the national legislation due to an outbreak of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease; II.3.2.4. in which no clinical, serological, virological or pathological evidence of Aujeszky's disease was detected in the preceding 12 months; II.3.3. prior to entering the quarantine accommodation, were not previously kept in any herd of a lower health status than described in II.3.2.; II.3.4. within 30 days prior to entering the quarantine accommodation referred to in point II.3.1, were subjected to the following tests, performed in accordance with international standards, with negative results: II.3.4.1. as regards brucellosis, a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA; II.3.4.2. as regards Aujeszky’s disease, ⁽²⁾ either [II.3.4.2.1. in the case of non-vaccinated animals, a serum neutralisation test or an ELISA for detecting antibodies to the whole Aujeszky’s disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD);] ⁽²⁾ or [II.3.4.2.1. in the case of animals vaccinated with a gE deleted vaccine, an ELISA for detecting antibodies to glycoprotein E (ADV-gE);] ⁽²⁾ either [II.3.5. were admitted to the centre after all of the animals had reacted with negative result to a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA carried out on samples collected during the last 15 days of the period of quarantine specified in point II.3.1;] ⁽²⁾ or [II.3.5. were admitted to the centre after not all of the animals had reacted with negative result to a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA carried out on samples collected during the last 15 days of the period of quarantine specified in point II.3.1 and the suspicion of brucellosis was ruled out in accordance with point 1.5. of Chapter I of Annex B to Directive 90/429/EEC;] II.3.6. were subjected to the following tests for Aujeszky's disease carried out on samples collected during the last 15 days of the period of quarantine specified in point II.3.1: ⁽²⁾ either [II.3.6.1. in the case of non-vaccinated animals, a serum neutralisation test or an ELISA for detecting antibodies to the whole Aujeszky’s disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD);] ⁽²⁾ or [II.3.6.1. in the case of animals vaccinated with a gE deleted vaccine, an ELISA for detecting antibodies to glycoprotein E (ADV-gE);] ⁽²⁾ either [II.3.6.2. the tests referred to in point II.3.6.1 were carried out with negative result in each case;] ⁽²⁾ or [II.3.6.2. the animals that proved positive in a test referred to in point II.3.6.1 were removed immediately from the quarantine accommodation and the competent authority took all necessary measures to ensure that the remaining animals had a satisfactory health status before being admitted to the collection centre in accordance with point II.3;] II.3.7. All tests were carried out in a laboratory approved by the competent authority; II.3.8. Animals were only admitted to the semen collection centre with the express permission of the centre veterinarian and all animal movements, entering and exiting the semen collection centre, are recorded; II.3.9. No animal admitted to the semen collection centre showed any clinical sign of disease on the day of admission; all animals came directly from the quarantine accommodation which, on the day of consignment and during the period of residency of the animals, officially fulfilled the following conditions: II.3.9.1. it was not situated in a restricted area defined under the provisions of national legislation due to an outbreak of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease; II.3.9.2. no clinical, serological, virological or pathological evidence of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease had been recorded for the past 30 days. Compulsory routine tests for animals kept at the semen collection centre II.4. All animals kept at the semen collection centre are subjected to the following routine tests carried out in a laboratory approved by the competent authority: II.4.1. as regards brucellosis, a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA; II.4.2. as regards Aujeszky’s disease virus, ⁽¹⁾ either [II.4.2.1. in the case of non-vaccinated animals, a serum neutralisation test or an ELISA for detecting antibodies to the whole Aujeszky’s disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD).] ⁽¹⁾ or [II.4.2.1. in the case of animals vaccinated with a gE deleted vaccine, an ELISA for detecting antibodies to glycoprotein E (ADV-gE).] II.4.3. The routine tests referred to in points II.4.1 and II.4.2 are carried out on samples taken in accordance with point 1.2. of Chapter II of Annex B to Directive 90/429/EEC in order to ensure that all animals in the centre have been tested at least once during their stay at that centre and at least every 12 months from the date of admission, if their stay exceeds 12 months; ⁽²⁾ either [II.4.4. All of the animals have reacted with negative results in the routine tests referred to in points II.4.1 and II.4.2 carried out on samples referred to in point II.4.3.] ⁽²⁾ or [II.4.4. Not all of the animals have reacted with negative results in the tests referred to in points II.4.1 and II.4.2., which were carried out on samples referred to in point II.4.3: (a) the animals which proved positive were isolated, (b) the semen collected from each animal at the centre since the date of that animal's last negative test was held in separate storage from semen eligible for export to the European Union which was collected before the animal's last negative test or after the health status of the centre had been re-established under responsibility of the competent authority of the exporting country.] Conditions for semen collected at a semen collection centre and intended for export to the Union II.5. The semen in this consignment was obtained from animals which: II.5.1. have been resident in … (name of third country ⁽¹⁾) for a minimum period of 3 months immediately prior to collection; II.5.2. showed no clinical signs of disease on the day the semen was collected; II.5.3. had not been vaccinated against foot-and-mouth disease; II.5.4. satisfy the requirements referred to in point II.3; II.5.5. have not been allowed to serve naturally; II.5.6. were kept in semen collection centres which were not situated in a restricted area designated under the provisions of the national legislation relating to foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease; II.5.7. were kept in semen collection centres in which no clinical, serological, virological or pathological evidence of foot-and-mouth disease, classical swine fever, African swine fever, swine vesicular disease, vesicular stomatitis and Aujeszky's disease has been detected in the 30-day period immediately prior to collection. II.6. An effective combination of antibiotics, in particular against leptospires, was added to the semen in this consignment after final dilution or to the diluent. In the case of frozen semen, antibiotics were added before the semen was frozen. II.6.1. The combination of antibiotics referred to in point II.6 produced an effect at least equivalent to the following concentration in the final diluted semen: (a) not less than 500 μg streptomycin per ml final dilution, (b) not less than 500 IU penicillin per ml final dilution, (c) not less than 150 μg lincomycin per ml final dilution, (d) not less than 300 μg spectinomycin per ml final dilution; II.6.2. Immediately after the addition of the antibiotics the diluted semen was kept at a temperature of at least 15 °C for a period of not less than 45 minutes. II.7. The semen in this consignment: II.7.1. has been stored as laid down in point 2(d) of Chapter I and point 6(a), (b), (e) and (f) of Chapter II of Annex A to Directive 90/429/EEC prior to dispatch; II.7.2. is being transported to the country of destination in flasks which were cleaned and disinfected or sterilised before use and which have been sealed prior to dispatch from the approved storage facilities. 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 to the Union. Only semen collection centre listed in accordance with Article 8(2) of Directive 90/429/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/porcine/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. 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 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. Part II: ⁽¹⁾ Only third country or territory, or zone thereof listed in Annex XI to Commission Implementing Regulation (EU) 2021/404 for semen of porcine animals. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only semen collection centres listed in accordance with Article 8(2) of Directive 90/429/EEC on the Commission website: https://ec.europa.eu/food/animals/semen/porcine_en. ⁽⁴⁾ This option shall be deleted in case the Member State or region thereof of destination is free of Aujeszky’s disease in accordance with Article 10 of Directive 64/432/EEC, has informed the Commission in accordance with point 4 of Annex C to Directive 90/429/EEC and is listed on the following Commission website: https://ec.europa.eu/food/animals/semen/porcine_en.


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

CHAPTER 56 MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF OOCYTES AND EMBRYOS OF PORCINE ANIMALS 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 AFTER 20 APRIL 2021, DISPATCHED BY THE EMBRYO COLLECTION OR PRODUCTION TEAM BY WHICH THE OOCYTES OR EMBRYOS WERE COLLECTED OR PRODUCED (MODEL “POR-OOCYTES-EMB-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-OOCYTES-EMB-ENTRY	Certificate model POR-OOCYTES-EMB-ENTRY	Certificate model POR-OOCYTES-EMB-ENTRY	Certificate model POR-OOCYTES-EMB-ENTRY
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference


I, the undersigned official veterinarian, hereby certify that: II.1. The [oocytes] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ described in Part I are intended for artificial reproduction and were obtained from donor animals which originate from a third country or territory, or zone thereof: II.1.1. authorised for the entry into the Union of [oocytes] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ 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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch;] ^{(1) (2)} or [II.1.2. where foot and mouth disease was not reported for a period starting on the date //_ (dd/mm/yyyy) immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch;] ⁽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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their 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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their 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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their 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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch, and no vaccinated animals entered into the third country or territory, or zone thereof during that period, and ⁽¹⁾ either [no vaccination against foot and mouth disease has been carried out for the same period, and no vaccinated animals entered into the third country or territory, or zone thereof during that period;] ⁽¹⁾ or [vaccination against foot and mouth disease has been carried out for the same period, or vaccinated animals entered into the third country or territory, or zone thereof during that period.] ^{(1) (3)} [II.1.6. free from infection with Aujeszky’s disease virus.] II.2. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I were obtained from donor animals which originate from establishments: II.2.1. in which infection with Brucella abortus, B. melitensis and B. suis in porcine animals has not been reported during 42 days immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾, and in which during at least 12 months immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾: ⁽¹⁾ either [II.2.2.1. biosecurity and risk mitigating measures, including housing conditions and feeding systems, have been applied as necessary to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis from wild animals of listed species to porcine animals kept in the establishments and only porcine animals from establishments applying equivalent biosecurity measures have been introduced.] ⁽¹⁾ and/or [II.2.2.2. surveillance for infection with Brucella abortus, B. melitensis and B. suis has been carried out on the porcine animals kept in the establishments in accordance with Annex III to Commission Delegated Regulation (EU) 2020/688, and during the same period: (a) only porcine animals from establishments applying such surveillance or biosecurity measures, including housing conditions and feeding systems, necessary to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis from wild animals of listed species to porcine animals kept on the establishments, have been introduced; and (b) in the case where infection with Brucella abortus, B. melitensis and B. suis has been reported in porcine animals kept therein, measures were taken in accordance with Part 1, point 3, of Annex II to Delegated Regulation (EU) 2020/688;] II.2.2. where no clinical, serological, virological or pathological evidence of infection with Aujeszky’s disease virus has been detected during at least 12 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾. ⁽¹⁾ [II.3. The [oocytes] ⁽¹⁾[in vivo derived embryos] ⁽¹⁾ described in Part I have been collected, processed and stored, and dispatched by the embryo collection team ⁽⁴⁾ 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 2 of Annex I to Delegated Regulation (EU) 2020/686.] ⁽¹⁾ [II.3. The [oocytes] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ described in Part I have been collected or produced, processed and stored, and dispatched by the embryo production team ⁽⁵⁾ 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 Parts 2 and 3 of Annex I to Commission Delegated Regulation (EU) 2020/686.] II.4. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I were 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] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ in a third country or territory, or zone thereof referred to in box I.7; II.4.3. for at least 30 days immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and during the collection period: II.4.3.1. were kept in establishments not situated in a restricted zone established due to the occurrence of foot and mouth disease, infection with rinderpest virus, classical swine fever or African swine fever, or of an emerging disease relevant for porcine animals; II.4.3.2. 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.4.3.3. were not in contact with animals from establishments situated in a restricted zone due to the occurrence of diseases referred to in point II.4.3.1 or from establishments which do not meet the conditions referred to in point II.4.3.2; II.4.3.4. were not used for natural breeding; II.4.4. have been clinically examined by the team veterinarian or a team member and did not show symptoms of transmissible diseases on the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; II.4.5. are individually identified as provided for in Article 21(1) of Delegated Regulation (EU) 2020/692; II.4.6. comply with the following conditions as regards foot and mouth disease: II.4.6.1. they come from establishments: (a) situated in an area where foot and mouth disease has not been reported within a 10-km radius centred in the establishments for at least 30 days immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; (b) in which foot and mouth disease has not been reported during at least 3 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; ⁽¹⁾ either [II.4.6.2. they were not vaccinated against foot and mouth disease;] ^{(1) (5)} or [II.4.6.2. they were vaccinated against foot and mouth disease during the 12 months immediately prior to the date of collection of the embryos, and: II.4.6.2.1. have not been vaccinated against foot and mouth disease within at least 30 days immediately prior to the date of collection of the embryos; II.4.6.2.2. the semen used for fertilisation was collected from a male donor that complies with the conditions set out in Part 5, Chapter I, point 1(b), of Annex II to Delegated Regulation (EU) 2020/686 or the semen complies with the conditions set out in Part 5, Chapter I, point 2, of Annex II to Delegated Regulation (EU) 2020/686; II.4.6.2.3. prior to freezing, the embryos have been subjected to trypsin washing carried out in accordance with the recommendations of the IETS Manual ⁽⁶⁾; II.4.6.2.4. the embryos were stored deep frozen for at least 30 days from the date of collection, and during that period the donor animal has not shown clinical signs of foot and mouth disease;] ^{(1) (7)} [II.4.7. were subjected to a serological test for infection with porcine reproductive and respiratory syndrome virus, with negative results, on two occasions, at an interval of not less than 21 days, the second test being performed within 15 days immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾.] II.5. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I: II.5.1. have been collected, processed and stored in accordance with animal health requirements set out in [Part 2] ⁽¹⁾ [Part 3] ⁽¹⁾ [Part 4] ⁽¹⁾ [Part 5] ⁽¹⁾and Part 6 of Annex III to Delegated Regulation (EU) 2020/686; II.5.2. are placed in straws or other packages on which the mark is applied in accordance with requirements provided for in Article 83, point (a), of Delegated Regulation (EU) 2020/692 and that mark is indicated in box I.27; II.5.3. are transported in a container which: II.5.3.1. was sealed and numbered prior to the date of dispatch by the embryo collection or production team under responsibility of the team veterinarian, or by an official veterinarian, and the seal bears the number as indicated in box I.19; II.5.3.2. has been cleaned and either disinfected or sterilised before use, or is single-use container; ^{(1) (8)} [II.5.3.3. has been filled in with a cryogenic agent which has not been previously used for other products;] ^{(1) (9)} [II.5.4. are placed in straws or other packages which are securely and hermetically sealed; II.5.5. are transported in a container where the different types are separated from each other by physical compartments or by being placed in secondary protective bags.] ^{(1) (10)} [II.6. The [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ described in Part I were conceived by artificial insemination using semen coming from a semen collection centre, germinal product processing establishment or germinal product storage centre approved for the collection, processing or storage of semen by the competent authority of a third country or territory, or zone thereof listed in Annex XI to Implementing Regulation (EU) 2021/404 for semen of porcine animals or by the competent authority of a Member State, and were collected, processed and stored in accordance with the requirements of Part 2, Chapter I, of Annex II, and of Part 1 of Annex III to Delegated Regulation (EU) 2020/686.] ^{(1) (11)} [II.7. The following antibiotic or mixture of antibiotics ⁽¹²⁾ has been added to the collection, processing, washing or storage media: … .] 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 oocytes and embryos of porcine animals, including when the Union is not the final destination of the 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 embryo collection or production team of dispatch of the consignment of oocytes or embryos. Only embryo collection or production teams listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: 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 oocytes or embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Type”: Specify if 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 oocytes or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which oocytes or embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo collection or production team by which the oocytes or embryos of the consignment were collected or produced. “Quantity”: Indicate 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 opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404. ⁽³⁾ Not applicable for in vivo derived embryos subject to trypsin treatment. ⁽⁴⁾ Only embryo collection or production teams 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. ⁽⁵⁾ Option available only for the consignment of in vivo derived embryos. ⁽⁶⁾ Manual of the International Embryo Technology Society — A procedural guide and general information for the use of embryo transfer technology emphasising sanitary procedures, published by the International Embryo Technology Society, 1 111 North Dunlap Avenue, Savoy, Illinois 61 874, USA (http://www.iets.org/). ⁽⁷⁾ Applicable for in vivo derived embryos. ⁽⁸⁾ Applicable for frozen oocytes or embryos. ⁽⁹⁾ Applicable for consignments where oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of porcine animals are placed and transported in one container. ⁽¹⁰⁾ Does not apply to oocytes. ⁽¹¹⁾ Mandatory attestation in case antibiotics were added. ⁽¹²⁾ Insert the name(s) of the antibiotic(s) added and its (their) concentration.

I, the undersigned official veterinarian, hereby certify that: II.1. The [oocytes] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ described in Part I are intended for artificial reproduction and were obtained from donor animals which originate from a third country or territory, or zone thereof: II.1.1. authorised for the entry into the Union of [oocytes] ⁽¹⁾ [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ 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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch;] ^{(1) (2)} or [II.1.2. where foot and mouth disease was not reported for a period starting on the date //_ (dd/mm/yyyy) immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch;] ⁽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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their 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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their 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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their 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 [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and until the date of their dispatch, and no vaccinated animals entered into the third country or territory, or zone thereof during that period, and ⁽¹⁾ either [no vaccination against foot and mouth disease has been carried out for the same period, and no vaccinated animals entered into the third country or territory, or zone thereof during that period;] ⁽¹⁾ or [vaccination against foot and mouth disease has been carried out for the same period, or vaccinated animals entered into the third country or territory, or zone thereof during that period.] ^{(1) (3)} [II.1.6. free from infection with Aujeszky’s disease virus.] II.2. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I were obtained from donor animals which originate from establishments: II.2.1. in which infection with Brucella abortus, B. melitensis and B. suis in porcine animals has not been reported during 42 days immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾, and in which during at least 12 months immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾: ⁽¹⁾ either [II.2.2.1. biosecurity and risk mitigating measures, including housing conditions and feeding systems, have been applied as necessary to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis from wild animals of listed species to porcine animals kept in the establishments and only porcine animals from establishments applying equivalent biosecurity measures have been introduced.] ⁽¹⁾ and/or [II.2.2.2. surveillance for infection with Brucella abortus, B. melitensis and B. suis has been carried out on the porcine animals kept in the establishments in accordance with Annex III to Commission Delegated Regulation (EU) 2020/688, and during the same period: (a) only porcine animals from establishments applying such surveillance or biosecurity measures, including housing conditions and feeding systems, necessary to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis from wild animals of listed species to porcine animals kept on the establishments, have been introduced; and (b) in the case where infection with Brucella abortus, B. melitensis and B. suis has been reported in porcine animals kept therein, measures were taken in accordance with Part 1, point 3, of Annex II to Delegated Regulation (EU) 2020/688;] II.2.2. where no clinical, serological, virological or pathological evidence of infection with Aujeszky’s disease virus has been detected during at least 12 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾. ⁽¹⁾ [II.3. The [oocytes] ⁽¹⁾[in vivo derived embryos] ⁽¹⁾ described in Part I have been collected, processed and stored, and dispatched by the embryo collection team ⁽⁴⁾ 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 2 of Annex I to Delegated Regulation (EU) 2020/686.] ⁽¹⁾ [II.3. The [oocytes] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ described in Part I have been collected or produced, processed and stored, and dispatched by the embryo production team ⁽⁵⁾ 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 Parts 2 and 3 of Annex I to Commission Delegated Regulation (EU) 2020/686.] II.4. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I were 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] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ in a third country or territory, or zone thereof referred to in box I.7; II.4.3. for at least 30 days immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ and during the collection period: II.4.3.1. were kept in establishments not situated in a restricted zone established due to the occurrence of foot and mouth disease, infection with rinderpest virus, classical swine fever or African swine fever, or of an emerging disease relevant for porcine animals; II.4.3.2. 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.4.3.3. were not in contact with animals from establishments situated in a restricted zone due to the occurrence of diseases referred to in point II.4.3.1 or from establishments which do not meet the conditions referred to in point II.4.3.2; II.4.3.4. were not used for natural breeding; II.4.4. have been clinically examined by the team veterinarian or a team member and did not show symptoms of transmissible diseases on the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; II.4.5. are individually identified as provided for in Article 21(1) of Delegated Regulation (EU) 2020/692; II.4.6. comply with the following conditions as regards foot and mouth disease: II.4.6.1. they come from establishments: (a) situated in an area where foot and mouth disease has not been reported within a 10-km radius centred in the establishments for at least 30 days immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; (b) in which foot and mouth disease has not been reported during at least 3 months immediately prior to the date of [collection] ⁽¹⁾ [production] ⁽¹⁾ of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾; ⁽¹⁾ either [II.4.6.2. they were not vaccinated against foot and mouth disease;] ^{(1) (5)} or [II.4.6.2. they were vaccinated against foot and mouth disease during the 12 months immediately prior to the date of collection of the embryos, and: II.4.6.2.1. have not been vaccinated against foot and mouth disease within at least 30 days immediately prior to the date of collection of the embryos; II.4.6.2.2. the semen used for fertilisation was collected from a male donor that complies with the conditions set out in Part 5, Chapter I, point 1(b), of Annex II to Delegated Regulation (EU) 2020/686 or the semen complies with the conditions set out in Part 5, Chapter I, point 2, of Annex II to Delegated Regulation (EU) 2020/686; II.4.6.2.3. prior to freezing, the embryos have been subjected to trypsin washing carried out in accordance with the recommendations of the IETS Manual ⁽⁶⁾; II.4.6.2.4. the embryos were stored deep frozen for at least 30 days from the date of collection, and during that period the donor animal has not shown clinical signs of foot and mouth disease;] ^{(1) (7)} [II.4.7. were subjected to a serological test for infection with porcine reproductive and respiratory syndrome virus, with negative results, on two occasions, at an interval of not less than 21 days, the second test being performed within 15 days immediately prior to the date of collection of the [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾.] II.5. The [oocytes] ⁽¹⁾ [embryos] ⁽¹⁾ described in Part I: II.5.1. have been collected, processed and stored in accordance with animal health requirements set out in [Part 2] ⁽¹⁾ [Part 3] ⁽¹⁾ [Part 4] ⁽¹⁾ [Part 5] ⁽¹⁾and Part 6 of Annex III to Delegated Regulation (EU) 2020/686; II.5.2. are placed in straws or other packages on which the mark is applied in accordance with requirements provided for in Article 83, point (a), of Delegated Regulation (EU) 2020/692 and that mark is indicated in box I.27; II.5.3. are transported in a container which: II.5.3.1. was sealed and numbered prior to the date of dispatch by the embryo collection or production team under responsibility of the team veterinarian, or by an official veterinarian, and the seal bears the number as indicated in box I.19; II.5.3.2. has been cleaned and either disinfected or sterilised before use, or is single-use container; ^{(1) (8)} [II.5.3.3. has been filled in with a cryogenic agent which has not been previously used for other products;] ^{(1) (9)} [II.5.4. are placed in straws or other packages which are securely and hermetically sealed; II.5.5. are transported in a container where the different types are separated from each other by physical compartments or by being placed in secondary protective bags.] ^{(1) (10)} [II.6. The [in vivo derived embryos] ⁽¹⁾ [in vitro produced embryos] ⁽¹⁾ [micromanipulated embryos] ⁽¹⁾ described in Part I were conceived by artificial insemination using semen coming from a semen collection centre, germinal product processing establishment or germinal product storage centre approved for the collection, processing or storage of semen by the competent authority of a third country or territory, or zone thereof listed in Annex XI to Implementing Regulation (EU) 2021/404 for semen of porcine animals or by the competent authority of a Member State, and were collected, processed and stored in accordance with the requirements of Part 2, Chapter I, of Annex II, and of Part 1 of Annex III to Delegated Regulation (EU) 2020/686.] ^{(1) (11)} [II.7. The following antibiotic or mixture of antibiotics ⁽¹²⁾ has been added to the collection, processing, washing or storage media: … .] 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 oocytes and embryos of porcine animals, including when the Union is not the final destination of the 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 embryo collection or production team of dispatch of the consignment of oocytes or embryos. Only embryo collection or production teams listed in accordance with Article 233(3) of Regulation (EU) 2016/429 on the Commission website: 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 oocytes or embryos. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Type”: Specify if 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 oocytes or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which oocytes or embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo collection or production team by which the oocytes or embryos of the consignment were collected or produced. “Quantity”: Indicate 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 opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404. ⁽³⁾ Not applicable for in vivo derived embryos subject to trypsin treatment. ⁽⁴⁾ Only embryo collection or production teams 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. ⁽⁵⁾ Option available only for the consignment of in vivo derived embryos. ⁽⁶⁾ Manual of the International Embryo Technology Society — A procedural guide and general information for the use of embryo transfer technology emphasising sanitary procedures, published by the International Embryo Technology Society, 1 111 North Dunlap Avenue, Savoy, Illinois 61 874, USA (http://www.iets.org/). ⁽⁷⁾ Applicable for in vivo derived embryos. ⁽⁸⁾ Applicable for frozen oocytes or embryos. ⁽⁹⁾ Applicable for consignments where oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of porcine animals are placed and transported in one container. ⁽¹⁰⁾ Does not apply to oocytes. ⁽¹¹⁾ Mandatory attestation in case antibiotics were added. ⁽¹²⁾ Insert the name(s) of the antibiotic(s) added and its (their) concentration.


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

CHAPTER 57 MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF GERMINAL PRODUCTS LISTED BELOW, DISPATCHED AFTER 20 APRIL 2021 FROM THE GERMINAL PRODUCT PROCESSING ESTABLISHMENT:

— semen of 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;

— stocks of semen of porcine animals collected, processed and stored in accordance with Council Directive 90/429/EEC before 21 April 2021;

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

(MODEL “POR-GP-PROCESSING-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 POR-GP-PROCESSING-ENTRY	Certificate model POR-GP-PROCESSING-ENTRY	Certificate model POR-GP-PROCESSING-ENTRY	Certificate model POR-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⁾ [in vivo derived embryos] ⁽²⁾ [in vitro produced embryos] ⁽²⁾ [micromanipulated embryos] ⁽²⁾ of porcine animals and listed in Annex XI 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;] ⁽²⁾ either [II.1.1.3. where classical swine fever was 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;] ^{(2) (3)} or [II.1.1.3. where classical swine fever was not reported for a period starting on the date //_ (dd/mm/yyyy) immediately prior to the date of [collection] ⁽²⁾ [production] ⁽²⁾ of the [semen] ⁽²⁾ [oocytes] ⁽²⁾ [embryos] ⁽²⁾ and until the date of its/their dispatch;] II.1.1.4. where infection with rinderpest virus and African swine fever were not reported for at least 12 months immediately prior to the date of [collection] ⁽²⁾ [production] ⁽²⁾ of the [semen] ⁽²⁾ [oocytes] ⁽²⁾ [embryos] ⁽²⁾ and until the date of its/their dispatch; II.1.1.5. 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] ⁽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 porcine 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 POR-SEM-A-ENTRY ⁽⁶⁾;] ⁽²⁾ and/or [Model POR-SEM-B-ENTRY ⁽⁶⁾;] ⁽²⁾ and/or [Model POR-OOCYTES-EMB-ENTRY ⁽⁶⁾;] ⁽²⁾ and/or [Model POR-GP-PROCESSING-ENTRY ⁽⁶⁾;] ⁽²⁾ and/or [Model POR-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 ”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, oocytes and embryos of porcine 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 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 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. “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 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: https://ec.europa.eu/food/animals/semen/porcine_en. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only for a third country or territory, or zone thereof with 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: https://ec.europa.eu/food/animals/semen/porcine_en. ⁽⁵⁾ Only a third country or territory, or zone thereof listed in Annex XI 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 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 porcine animals are placed and transported in one container.

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⁾ [in vivo derived embryos] ⁽²⁾ [in vitro produced embryos] ⁽²⁾ [micromanipulated embryos] ⁽²⁾ of porcine animals and listed in Annex XI 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;] ⁽²⁾ either [II.1.1.3. where classical swine fever was 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;] ^{(2) (3)} or [II.1.1.3. where classical swine fever was not reported for a period starting on the date //_ (dd/mm/yyyy) immediately prior to the date of [collection] ⁽²⁾ [production] ⁽²⁾ of the [semen] ⁽²⁾ [oocytes] ⁽²⁾ [embryos] ⁽²⁾ and until the date of its/their dispatch;] II.1.1.4. where infection with rinderpest virus and African swine fever were not reported for at least 12 months immediately prior to the date of [collection] ⁽²⁾ [production] ⁽²⁾ of the [semen] ⁽²⁾ [oocytes] ⁽²⁾ [embryos] ⁽²⁾ and until the date of its/their dispatch; II.1.1.5. 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] ⁽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 porcine 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 POR-SEM-A-ENTRY ⁽⁶⁾;] ⁽²⁾ and/or [Model POR-SEM-B-ENTRY ⁽⁶⁾;] ⁽²⁾ and/or [Model POR-OOCYTES-EMB-ENTRY ⁽⁶⁾;] ⁽²⁾ and/or [Model POR-GP-PROCESSING-ENTRY ⁽⁶⁾;] ⁽²⁾ and/or [Model POR-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 ”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, oocytes and embryos of porcine 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 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 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. “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 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: https://ec.europa.eu/food/animals/semen/porcine_en. ⁽²⁾ Delete if not applicable. ⁽³⁾ Only for a third country or territory, or zone thereof with 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: https://ec.europa.eu/food/animals/semen/porcine_en. ⁽⁵⁾ Only a third country or territory, or zone thereof listed in Annex XI 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 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 porcine animals are placed and transported in one container.


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

CHAPTER 58 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:

— 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;

— stocks of semen of porcine animals collected, processed and stored in accordance with Council Directive 90/429/EEC before 21 April 2021;

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

(MODEL “POR-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 POR-GP-STORAGE-ENTRY	Certificate model POR-GP-STORAGE-ENTRY	Certificate model POR-GP-STORAGE-ENTRY	Certificate model POR-GP-STORAGE-ENTRY
	II. Health information	II.a	Certificate reference	II.b	IMSOC reference

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