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, of the exporting country (1) … hereby certify that: (name of exporting country) II.1. The semen collection centre (2), in which the semen described in Part I was collected, processed and stored for export to the Union was approved and supervised by the competent authority in accordance with the conditions of Chapter I(I)(1) and Chapter I(II)(1) of Annex D to Directive 92/65/EEC, II.2. during the period commencing 30 days prior to the date of first collection of the semen described in Part I until the 30 days storage period for frozen semen elapsed, the semen collection centre: II.2.1. was situated in the exporting country or, in the case of regionalisation according to Article 13 of Directive 2009/156/EC (3), in that part of the territory of the exporting country which was: — not considered to be infected with African horse sickness in accordance with Article 5(2)(a) and (b) of Directive 2009/156/EC (3), — free from Venezuelan equine encephalomyelitis for 2 years, — free from glanders and dourine for 6 months; II.2.2. fulfilled the conditions for a holding laid down in Article 4(5) of Directive 2009/156/EC (3) and in particular: (4) either [II.2.2.1. following a case of a disease mentioned below not all the animals of species susceptible to the disease located on the holding were slaughtered or killed and the holding has been free: — from any type of equine encephalomyelitis for at least 6 months, beginning on the day on which the equidae suffering from the disease are slaughtered, — from equine infectious anaemia for at least the period required to obtain a negative result in an agar gel immunodiffusion test (Coggins test) carried out on samples taken after the infected animals were slaughtered on two occasions 3 months apart from each of the remaining animals, — from vesicular stomatitis for at least 6 months from the last recorded case, — from rabies for at least one month from the last recorded case, — from anthrax for at least 15 days from the last recorded case,] (4) or [II.2.2.1. following a case of a disease mentioned below all the animals of species susceptible to the disease located on the holding have been slaughtered or killed and the premises disinfected, the holding has been free for at least 30 days from any type of equine encephalomyelitis, equine infectious anaemia, vesicular stomatitis and rabies or 15 days in the case of anthrax, beginning on the day on which following the destruction of the animals the disinfection of the premises was satisfactorily completed;] II.2.3. contained only equidae which were free of clinical signs of equine viral arteritis and contagious equine metritis, II.3. Prior to entering the semen collection centre the donor stallions and any other equidae located in the centre: II.3.1. were continuously resident for 3 months (or since entry if they were directly imported from a Member State of the European Union during the 3 months period) in the exporting country or, in the case of regionalisation according to Article 13 of Directive 2009/156/EC (3), in that part of the territory of the exporting country which was during that period — not considered to be infected with African horse sickness in accordance with Article 5(2)(a) and (b) of Directive 2009/156/EC (3), — free from Venezuelan equine encephalomyelitis for at least 2 years, — free from glanders and dourine for at least 6 months; (4) either [II.3.2. originated from the country of export which was on the day of admission into the centre free of vesicular stomatitis (VS) for at least 6 months,] (4) or [II.3.2. were subjected to a virus neutralisation test for vesicular stomatitis (VS) carried out with negative result at a serum dilution of 1 in 12 on a blood sample taken (5) within 14 days prior to entering the centre;] II.3.3. originated from holdings which on the day of admission onto the centre fulfilled the requirements of point II.2.2; II.4. The semen described in Part I was collected from donor stallions, which: II.4.1. have not shown any clinical sign of an infectious or contagious disease at the time of admission onto the centre and on the day the semen was collected; II.4.2. have been kept for 30 days prior to the date of semen collection on holdings where no equine animal has shown any clinical sign of equine viral arteritis or contagious equine metritis during that period; II.4.3. have not been used for natural mating during at least 30 days prior to the date of first semen collection and between the dates of the first sample referred to in points II.4.5.1, II.4.5.2 and/or II.4.5.3. and until the end of the collection period; II.4.4. have undergone the following tests, which meet at least the requirements of the relevant Chapter of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE, carried out on samples taken in accordance with one of the programmes specified in point II.4.5 in a laboratory recognised by the competent authority: (4) (6) either [II.4.4.1. an agar-gel immuno-diffusion test (Coggins test) for equine infectious anaemia (EIA) with negative result;] (4) (6) or [II.4.4.1. an ELISA for equine infectious anaemia (EIA) with negative result;] and (4) either [II.4.4.2. a serum neutralisation test for equine viral arteritis (EVA) with negative result at a serum dilution of one in four;] (4) or [II.4.4.2. a virus isolation test for equine viral arteritis (EVA) carried out with negative result on an aliquot of the entire semen of the donor stallion;] and II.4.4.3. an agent identification test for contagious equine metritis (CEM) carried out on two occasions on samples collected with an interval of 7 days by isolation of Taylorella equigenitalis after a cultivation of 7 to 14 days from pre-ejaculatory fluid or a semen sample and from genital swabs taken at least from the penile sheath, urethra and urethral fossa with negative result in each case; II.4.5. have been subjected with the results specified in II.4.4 in each case to at least one of the test programmes (7) detailed in points II.4.5.1, II.4.5.2 and II.4.5.3 as follows: (4) [II.4.5.1. The donor stallion was continuously resident on the semen collection centre for at least 30 days prior to the date of the first collection and during the period of collection of the semen described in Part I, and no equidae on the semen collection centre came during that time into direct contact with equidae of lower health status than the donor stallion. The tests described in point II.4.4 have been carried out on samples taken (5) prior to the first semen collection and at least 14 days following the date of the commencement of the residence period of at least 30 days.] (4) [II.4.5.2. The donor stallion was resident on the semen collection centre for at least 30 days prior to the date of the first collection and during the period of collection of the semen described in Part I, but has left the centre under the responsibility of the centre veterinarian for a continuous period of less than 14 days, or other equidae on the collection centre came into direct contact with equidae of lower health status. The tests described in point II.4.4 have been carried out on samples taken (5) prior to the date of the first semen collection of the breeding season or collection period in the year the semen described in Part I was collected and at least 14 days following the date of the commencement of the residence period of at least 30 days, and the test described in point II.4.4.1 for equine infectious anaemia was last carried out on a sample of blood taken (5) not more than 90 days before the semen described in Part I was collected; and (4) either [one of the tests described in point II.4.4.2 for equine viral arteritis was last carried out on a sample taken (5) not more than 30 days before the semen described in Part I was collected,] (4) or [a virus isolation test for equine viral arteritis was carried out with negative result on an aliquot of the entire semen of the donor stallion taken (5) not more than 6 months before the semen described in Part I was collected and a blood sample taken on the same date (5) reacted positive in a serum neutralisation test for equine viral arteritis at a serum dilution of more than one in four,] and the test described in point II.4.4.3 for contagious equine metritis was last carried out on samples taken (5), not more than 60 days before the semen described in Part I was collected.] (4) [II.4.5.3. The tests described in point II.4.4 have been carried out on samples taken (5) prior to the date of the first semen collection of the breeding season or collection period in the year the semen described in Part I was collected, and the tests described in point II.4.4 have been carried out on samples taken (5) between 14 and 90 days after the collection of the semen described in Part I.] II.4.6. have undergone the testing provided for in points II.3.2 (4) and II.4.5 on samples taken on the following dates: Identification of semen Test programme Start date (5) Date of sampling for health tests (5) Donor residence Semen collection VS (4) II.3.2 EIII.4.4.1 EVA II.4.4.2 CEM II.4.4.3 Blood sample Semen sample 1. sample 2. sample (4) either [II.5. No antibiotics were added to the semen;] (4) or [II.5. The following antibiotic or combination of antibiotics was added to produce a concentration in the final diluted semen of not less than (8): … … ;] II.6. The semen described in Part I was: II.6.1. collected, processed, stored and transported under conditions which comply with the requirements of Chapters II(I)(1) and III(I) of Annex D to Directive 92/65/EEC; II.6.2. sent to the place of loading in a sealed container in accordance with point 1.4 of Chapter III(I) of Annex D to Directive 92/65/EEC and bearing the number indicated in box I.19. Notes This animal health certificate is intended for the entry into the Union of semen of equine 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” shall correspond to the semen collection centre of the semen origin. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of semen. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Type”: Indicate semen. “Identification number”: Indicate 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 in the following format: dd.mm.yyyy. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the semen collection centre where the semen of the consignment was collected. “Quantity”: Indicate the number of straws or other packages with the same mark. Part II: Guidance for the completion of the table in point II.4.6. Abbreviations: VS Vesicular stomatitis (VS) testing if required in accordance with point II.3.2 EIA-1 Equine infectious anaemia (EIA) testing first occasion EIA-2 EIA testing second occasion EVA-B1 Equine viral arteritis (EVA) testing on a blood sample first occasion EVA-B2 EVA testing on a blood sample second occasion EVA-S1 EVA testing on a semen sample first occasion EVA-S2 EVA testing on a semen sample second occasion CEM-11 Contagious equine metritis (CEM) testing first occasion first sample CEM-12 CEM testing first occasion second sample taken 7 days after CEM-11 CEM-21 CEM testing second occasion first sample CEM-22 CEM testing second occasion second sample taken 7 days after CEM-21 Instructions: For each semen identified in column A of the table and indicated in box I.27, the test programme (II.4.5.1, II.4.5.2 and/or II.4.5.3) shall be specified in column B of the table, and columns C and D of the table shall be completed with the dates required. The dates when samples were taken for laboratory testing prior to the first collection of the semen described in Part I as required by II.4.5.1, II.4.5.2 and II.4.5.3, are entered in the upper line of columns 5 to 9 of the table, this being the boxes marked with EIA-1, EVA-B1 or EVA-S1 and CEM-11 and CEM-12 in the example below. The dates when samples were taken for repeat laboratory testing as required in accordance with II.4.5.2 or II.4.5.3 are entered in the lower line of columns 5 to 9 of the table, this being the boxes EIA-2, EVA-B2 or EVA-S2 and CEM-21 and CEM-22 in the example below. Identification of semen Test programme Start date Date of sampling for health tests Donor residence Semen collection VS II.3.2 EIAII.4.4.1 EVA II.4.4.2 CEM II.4.4.3 Blood sample Semen sample 1.sample 2.sample A B C D VS EIA-1 EVA-B1 EVA-S1 CEM-11 CEM-12 EIA-2 EVA-B2 EVA-S2 CEM-21 CEM-22 (1) Entry into the Union of equine semen is authorised from a third country or territory listed in column 1 of the table in Part 1 of Annex XII to Commission Implementing Regulation (EU) 2021/404 provided the semen was collected in the zone detailed in column 2 of the table in Part 1 of that Annex from a donor stallion of the category of equine animals indicated in column 3 of the table in Part 1 of that Annex. (2) Only semen collection centres listed in accordance with Article 17(3), point (b), of Directive 92/65/EEC on the Commission website: https://ec.europa.eu/food/animals/semen/equine_en . (3) OJ L 192, 23.7.2010, p. 1. (4) Delete if not applicable. (5) Insert date in table in point II.4.6 (follow guidance in Part II of the Notes) (6) The agar gel immunodiffusion test (Coggins test) or the ELISA for equine infectious anaemia are not required for donor equine animals which have continuously resided in Iceland since birth, provided that Iceland has remained officially free of equine infectious anaemia and no equine animals and their semen, ova and embryos have been introduced into Iceland from outside prior to and during the period the semen was collected. (7) Cross out the programmes that do not apply to the consignment. (8) Insert names and concentrations.
Official veterinarian Official veterinarian
Name (in capital letters)
Date Qualification and title
Stamp Signature

CHAPTER 62

MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF STOCKS OF SEMEN OF EQUINE ANIMALS COLLECTED, PROCESSED AND STORED IN ACCORDANCE WITH COUNCIL DIRECTIVE 92/65/EEC BEFORE 1 SEPTEMBER 2010, DISPATCHED AFTER 20 APRIL 2021 FROM THE SEMEN COLLECTION CENTRE WHERE THE SEMEN WAS COLLECTED (MODEL “EQUI-SEM-D-ENTRY”)

Part I:   Description of consignment

COUNTRY Animal health certificate to the EU
--- ---
I.1 Consignor/Exporter
Name
Address
Address
Country
I.5 Consignee/Importer
Name
Address
Country
I.7 Country of origin
I.8 Region of origin
I.11 Place of dispatch
Name
Address
Country
I.13 Place of loading
--- ---
I.15 Means of transport
☐ Aircraft
☐ Railway
Identification
--- ---
I.18 Transport conditions
I.19 Container number/Seal number
Container No
I.20 Certified as or for
--- ---
I.21 ☐ For transit
Third country
--- ---
I.24 Total number of packages
--- ---
I.27 Description of consignment
CN code Species
Type

Part II:   Certification

COUNTRY COUNTRY Certificate model EQUI-SEM-D-ENTRY Certificate model EQUI-SEM-D-ENTRY Certificate model EQUI-SEM-D-ENTRY Certificate model EQUI-SEM-D-ENTRY
II. Health information II.a Certificate reference II.b IMSOC reference
I, the undersigned, official veterinarian, of the exporting country (1) … hereby (name of exporting country) certify that: II.1. The semen collection centre (2) in which the semen described in Part I was collected, processed and stored for export to the Union: II.1.1. was approved and supervised by the competent authority according to the conditions of Chapter I, Annex D to Directive 92/65/EEC, II.1.2. is situated in the territory or in the case of regionalisation according to Article 13 of Directive 2009/156/EC (3) in a part of the territory of the country of export which was on the day the semen was collected until the date of dispatch free of: — African horse sickness, in accordance with EU legislation, — Venezuelan equine encephalomyelitis for 2 years, — glanders and dourine for 6 months; II.1.3. was during the period commencing 30 days prior to the date of collection of the semen until the day of its dispatch not subject to a prohibition order for animal health reasons which laid down one of the following conditions: II.1.3.1. if not all the animals of species susceptible to the disease located in the holding were slaughtered or killed, the prohibition lasted for: — 6 months, beginning on the day on which the equidae suffering from the disease are slaughtered, in the case of equine encephalomyelitis, — a period required to carry out with negative result two Coggins tests 3 months apart in the animals remaining after the infected animals have been slaughtered, in the case of infectious equine anaemia, — 6 months, in the case of vesicular stomatitis, — one month from the last recorded case, in the case of rabies, — 15 days from the last recorded case, in the case of anthrax. II.1.3.2. if all the animals of species susceptible to the disease located in the holding have been slaughtered or killed and the premises disinfected, the prohibition lasted for 30 days, or 15 days in the case of anthrax, beginning on the day on which following the destruction of the animals the disinfection of the premises was satisfactorily completed; II.1.4. contained during the period commencing 30 days prior to semen collection and lasting until the date of its dispatch only equidae which were free of clinical signs of equine viral arteritis and contagious equine metritis, II.2. Prior to entering the semen collection centre the donor stallions and any other equidae located in the centre: II.2.1. were continuously resident for 3 months (or since entry if they were directly imported from a Member State during the 3 months period) in the territory or in the case of regionalisation in a part of the territory (4) of the country of export which was during that period free of: — African horse sickness, in accordance with EU legislation, — Venezuelan equine encephalomyelitis for 2 years, — glanders for 6 months, — dourine for 6 months; (4) either [II.2.2. originated from the territory of the country of export which was on the day of admission into the centre free of vesicular stomatitis for 6 months,] (4) or [II.2.2. were tested by a virus neutralisation test for vesicular stomatitis in a blood sample taken on … (5), this being within 14 days prior to entering the centre, with negative result at a serum dilution of 1 in 12;] II.2.3. originated from holdings which on the day of admission onto the centre fulfilled the requirements of point II.1.3; II.3. The semen described in part I was collected from donor stallions, which: II.3.1. on the day the semen was collected have not shown clinical signs of an infectious or contagious disease, II.3.2. during at least 30 days prior to collection of the semen have not been used for natural service, II.3.3. during the last 30 day period prior to collection of the semen have been kept on holdings where no equine animal showed clinical signs of equine viral arteritis, II.3.4. during the last 60 day period prior to collection of the semen have been kept on holdings where no equine animal showed clinical signs of contagious equine metritis, II.3.5. to the best of my knowledge and as far as I could ascertain have not been in contact with equidae suffering from an infectious or contagious disease the 15 days immediately preceding the collection of the semen; II.3.6. have undergone the following animal health tests carried out in a laboratory recognised by the competent authority, in accordance with a test programme as specified in point II.3.7: II.3.6.1. an agar-gel immuno-diffusion test (Coggins test) for equine infectious anaemia with negative result (6); (4) either [II.3.6.2. a serum neutralisation test for equine viral arteritis with negative result at a serum dilution of 1 in 4;] (4) or [II.3.6.2. a virus isolation test for equine viral arteritis carried out with negative result on an aliquot of the entire semen;] II.3.6.3. a test for contagious equine metritis carried out on two occasions with an interval of 7 days by isolation of Taylorella equigenitalis from pre-ejaculatory fluid or a semen sample and from genital swabs taken at least from the penile sheath, urethra and from the urethral fossa with negative result in each case; II.3.7. have been subjected to one of the following test programmes (7): (4) [II.3.7.1. The donor stallion was continuously resident on the collection centre for at least 30 days prior to the semen collection, and during the collection period, and no equidae in the collection centre came during that time into direct contact with equidae of lower health status than the donor stallions. The tests required in point II.3.6 have been carried out on samples taken on … (5) and on … (5) at least 14 days after the commencement of the above residence period and at least at the beginning of the breeding season.] (4) [II.3.7.2. The donor stallion was not continuously resident on the collection centre or other equidae on the collection centre came into direct contact with equidae of lower health status than the donor stallions. The tests required in point II.3.6 have been carried out on samples taken on … (5) and on … (5), within the 14 days period before the first semen collection and at least at the beginning of breeding season. The test required in point II.3.6.1 was last carried out on a sample of blood taken not more than 120 days before the semen was collected on … (5); (4) either [The test required in point II.3.6.2 was last carried out not more than 30 days before the semen was collected on … (5).]] (4) or [The non-shedder state of the seropositive stallion for equine viral arteritis was confirmed by a virus isolation test which was carried out not more than one year before the semen was collected on … (5).]] (4) [II.3.7.3. The tests required in point II.3.6 have been carried out during the 30 days mandatory storage period of frozen semen and not less than 14 days after the collection of the semen on samples taken on … (5) and on … (5).] II.4. The semen described in Part I was collected, processed, stored and transported under conditions which comply with the requirements of Chapters II and III of Annex D of Directive 92/65/EEC. Notes This animal health certificate is intended for the entry into the Union of semen of equine 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” shall correspond to the semen collection centre of the semen origin. Box reference I.12 : “Place of destination”: Indicate the address and unique registration or approval number of the establishment of destination of the consignment of semen. Box reference I.19 : Seal number shall be indicated. Box reference I.24 : Total number of packages shall correspond to the number of containers. Box reference I.27 : “Type”: Indicate semen. “Identification number”: Indicate 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 in the following format: dd.mm.yyyy. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the semen collection centre where the semen of the consignment was collected. “Quantity”: Indicate the number of straws or other packages with the same mark. Part II: (1) Entry into the Union of equine semen is authorised from a third country or territory listed in column 1 of the table in Part 1 of Annex XII to Commission Implementing Regulation (EU) 2021/404 provided the semen was collected in the zone detailed in column 2 of the table in Part 1 of that Annex from a donor stallion of the category of equine animals indicated in column 3 of the table in Part 1 of that Annex. (2) Only semen collection centres listed in accordance with Article 17(3), point (b), of Directive 92/65/EEC on the Commission website: https://ec.europa.eu/food/animals/semen/equine_en . (3) OJ L 192, 23.7.2010, p. 1. (4) Delete if not applicable. (5) Insert date. (6) The agar gel immunodiffusion test (Coggins test) or the ELISA for equine infectious anaemia are not required for donor equine animals which have continuously resided in Iceland since birth, provided that Iceland has remained officially free of equine infectious anaemia and no equine animals and their semen, ova and embryos have been introduced into Iceland from outside prior to and during the period the semen was collected. (7) Cross out the programmes that do not apply to the consignment.
Official veterinarian Official veterinarian
Name (in capital letters)
Date Qualification and title
Stamp Signature

CHAPTER 63

MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF OOCYTES AND EMBRYOS OF EQUINE 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 “EQUI-OOCYTES-EMB-A-ENTRY”)

Part I:   Description of consignment

COUNTRY Animal health certificate to the EU
--- ---
I.1 Consignor/Exporter
Name
Address
Address
Country
I.5 Consignee/Importer
Name
Address
Country
I.7 Country of origin
I.8 Region of origin
I.11 Place of dispatch
Name
Address
Country
I.13 Place of loading
--- ---
I.15 Means of transport
☐ Aircraft
☐ Railway
Identification
--- ---
I.18 Transport conditions
I.19 Container number/Seal number
Container No
I.20 Certified as or for
--- ---
I.21 ☐ For transit
Third country
--- ---
I.24 Total number of packages
--- ---
I.27 Description of consignment
CN code Species
Type

Part II:   Certification

COUNTRY COUNTRY Certificate model EQUI-OOCYTES-EMB-A-ENTRY Certificate model EQUI-OOCYTES-EMB-A-ENTRY Certificate model EQUI-OOCYTES-EMB-A-ENTRY Certificate model EQUI-OOCYTES-EMB-A-ENTRY
II. Health information II.a Certificate reference II.b IMSOC reference
I, the undersigned official veterinarian, hereby certify that: II.1. The [oocytes] (1) [in vivo derived embryos] (1) [in vitro produced embryos] (1) [micromanipulated embryos] (1) described in Part I are intended for artificial reproduction and were obtained from donor animals which originate: II.1.1. from a third country or territory, or zone thereof: II.1.1.1. authorised for the entry into the Union of [oocytes] (1) [embryos] (1) 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] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and until the date of 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] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and until the date of their dispatch in accordance with Article 22(4), point (b), of that Delegated Regulation; II.1.1.3. where Venezuelan equine encephalomyelitis was not reported for at least 24 months immediately prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and until the date of their dispatch; II.1.2. from an establishment in a third country or territory, or zone thereof: (1) 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] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and until the date of their dispatch;] (1) 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] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and until the date of 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;] (1) either [II.1.2.2. where dourine was not reported for at least 24 months immediately prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and until the date of their dispatch;] (1) or [II.1.2.2. where dourine was not reported for at least 6 months immediately prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and until the date of their dispatch, and 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;] (1) either [II.1.2.3. where surra (Trypanosoma evansi) was not reported for at least 24 months immediately prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and until the date of their dispatch;] (1) or [II.1.2.3. where surra (Trypanosoma evansi) was not reported for at least 6 months immediately prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and until the date of their dispatch, and 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.2. The [oocytes] (1) [embryos] (1) described in Part I were obtained from donor animals which originate from establishments: II.2.1. in which (1) either [surra has not been reported during 2 years immediately prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1);] (1) or [surra has not been reported during the period of the preceding 30 days prior to [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1), and when the disease was reported in the establishments during the preceding 2 years prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) following the last outbreak, the establishments have remained under movement restrictions (1) either [until the date on which the remaining animals in the establishments have been subjected to a test for surra with one of the diagnostic methods provided for in Part 3 of Annex I to Commission Delegated Regulation (EU) 2020/688, carried out, with negative results, on samples taken at least 6 months after the date on which the last infected animal has been removed from the establishments;]] (1) or [for at least 30 days from the date of cleaning and disinfection and after the date on which the last animal of listed species in the establishments was either killed and destroyed or slaughtered.]] II.2.2. in which (1) either [dourine has not been reported during the preceding 2 years prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1);] (1) or [dourine has not been reported during the preceding 6 months prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1), and when the disease was reported in the establishments during the preceding 2 years prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) following the last outbreak, the establishments have remained under movement restrictions (1) either [until the date on which the remaining equine animals in the establishments, except castrated male equine animals, have been subjected to a test for dourine with the diagnostic method provided for in Part 8 of Annex I to Delegated Regulation (EU) 2020/688, carried out, with negative results, on samples taken at least 6 months after the date on which the infected animals have been killed and destroyed or slaughtered, or the infected entire male equine animals have been castrated;]] (1) or [for at least 30 days after the date on which the last equine animal in the establishments was either killed and destroyed or slaughtered, and the premises were cleaned and disinfected;]] II.2.3. in which (1) either [equine infectious anaemia has not been reported during the preceding 12 months prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1);] (1) or [equine infectious anaemia has not been reported during the preceding 90 days prior to the date of [collection] (1) [production] (1)of the [oocytes] (1) [embryos] (1), and when the disease was reported in the establishments during the preceding 12 months prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) following the last outbreak, the establishments have remained under movement restrictions (1) either [until the date on which the remaining equine animals in the establishments have been subjected to a test for equine infectious anaemia with the diagnostic method provided for in Part 9 of Annex I to Delegated Regulation (EU) 2020/688, carried out, with negative results, on samples taken on two occasions with a minimum interval of 3 months after the date on which the infected animals have been killed and destroyed or slaughtered, and the establishments were cleaned and disinfected.]] (1) or [for at least 30 days after the date on which the last equine animal in the establishments was either killed and destroyed or slaughtered, and the establishments were cleaned and disinfected.]] (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 (2) 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 Commission 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 (2) 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 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 African horse sickness at least in the last 40 days immediately prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1); II.4.2. were not vaccinated against Venezuelan equine encephalomyelitis at least in the last 60 days immediately prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1); II.4.3. 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.4.4. 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.4.4.1. were kept in establishments not situated in a restricted zone established due to the occurrence of African horse sickness, infection with Burkholderia mallei (glanders) or of an emerging disease relevant for equine animals; II.4.4.2. were kept in establishments where Venezuelan equine encephalomyelitis, dourine, surra (Trypanosoma evansi), equine infectious anaemia, contagious equine metritis (Taylorella equigenitalis), infection with rabies virus and anthrax have not been reported; II.4.4.3. were not in contact with animals from establishments situated in a restricted zone due to the occurrence of diseases referred to in point II.4.4.1 or from establishments which do not meet the conditions referred to in point II.4.4.2; II.4.5. were not used for natural breeding during at least 30 days immediately prior to the date of the collection of the [oocytes] (1) [embryos] (1) and between the date on which the first samples referred to in points II.4.8.1 and II.4.8.2 were taken and the date of collection of the [oocytes] (1) [embryos] (1); II.4.6. were examined by the team veterinarian or a team member and did not show symptoms or clinical signs of transmissible animal diseases on the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1); II.4.7. are individually identified as provided for in Article 21(2) of Delegated Regulation (EU) 2020/692; II.4.8. were subjected to the following tests, referred to in Part 4, Chapter II, points 2(b) and (c), of Annex II to Delegated Regulation (EU) 2020/686, as follows: (3) [II.4.8.1. for equine infectious anaemia (EIA), an agar-gel immuno-diffusion test (AGID or Coggins test) or an enzyme-linked immunosorbent assay (ELISA) with a negative result carried out on a blood sample taken on … (4), being not less than 14 days following the date of commencement of the period referred to in point II.4.5 and not more than 90 days prior to the date of collection of the [oocytes] (1)[embryos] (1) intended for entry into the Union;] II.4.8.2. for contagious equine metritis (CEM), an agent identification test carried out with a negative result on at least two specimens (swabs) taken during the period referred to in point II.4.5 from at least the mucosal surfaces of the clitoral fossa and the clitoral sinuses of the donor mare: (1) either [II.4.8.2.1. on two occasions with an interval of not less than 7 days on … (4) and on … (4), in the case of isolation of Taylorella equigenitalis after cultivation under microaerophilic conditions for at least 7 days, set up within 24 hours after taking the specimens from the donor animal, or 48 hours where the specimens are kept cool during transport.] (1) and/or [II.4.8.2.2. on one occasion on ____ (4), in the case of detection of the genome of Taylorella equigenitalis by a polymerase chain reaction (PCR) or real-time PCR, carried out within 48 hours immediately after taking the specimens from the donor animal.] The samples referred to in points II.4.8.2.1 and II.4.8.2.2 were in no case taken earlier than 7 days (systemic treatment) or 21 days (local treatment) after antimicrobial treatment of the donor mare and were placed in a transport medium with activated charcoal, such as Amies medium, before dispatch to the laboratory. 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 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) (5) [II.5.3.3. has been filled in with a cryogenic agent which has not been previously used for other products.] (1) (6) [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) (7) [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 XII to Implementing Regulation (EU) 2021/404 for semen of equine animals or by the competent authority of a Member State (8), and were collected, processed and stored in accordance with the requirements of Part 4, Chapter I and Part 1 of Annex III to Delegated Regulation (EU) 2020/686.] (1) (9) [II.7. The following antibiotic or mixture of antibiotics (10) has been added to the collection, processing, washing or storage media: … .] Notes This animal health certificate is intended for the entry into the Union of oocytes and embryos of equine 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/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 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 the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where oocytes or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which oocytes or embryos of the consignment were collected or produced. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the embryo collection or production team by which the oocytes or embryos of the consignment were collected or produced. “Quantity”: Indicate the number of straws or other packages with the same mark. Part II: (1) Delete if not applicable. (2) 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/equine_en. (3) The agar gel immunodiffusion test (AGID or Coggins test) or the ELISA for equine infectious anaemia are not required for donor equine animals which continuously resided in Iceland since birth, provided that Iceland remained officially free of equine infectious anaemia and no equine animals and their semen, ova and embryos were introduced into Iceland from outside prior to and during the period the ova or embryos were collected and the semen was used for fertilisation. (4) Insert date in the following format: dd.mm.yyyy. (5) Applicable for frozen oocytes or embryos. (6) Applicable for consignments where oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of equine animals are placed and transported in one container. (7) Does not apply to oocytes. (8) Only a semen collection centre, germinal product processing establishment or germinal product storage centre listed on the Commission websites for: (a) third countries or territories, or zones thereof: https://ec.europa.eu/food/animals/live_animals/approved-establishments_en; (b) Member States: https://ec.europa.eu/food/animals/semen/equine_en. (9) Mandatory attestation in case antibiotic(s) were added. (10) 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 64

MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF STOCKS OF OOCYTES AND EMBRYOS OF EQUINE ANIMALS COLLECTED OR PRODUCED, PROCESSED AND STORED IN ACCORDANCE WITH COUNCIL DIRECTIVE 92/65/EEC AFTER 30 SEPTEMBER 2014 AND BEFORE 21 APRIL 2021, DISPATCHED AFTER 20 APRIL 2021 BY THE EMBRYO COLLECTION OR PRODUCTION TEAM BY WHICH THE OOCYTES OR EMBRYOS WERE COLLECTED OR PRODUCED (MODEL “EQUI-OOCYTES-EMB-B-ENTRY”)

Part I:   Description of consignment

COUNTRY Animal health certificate to the EU
--- ---
I.1 Consignor/Exporter
Name
Address
Address
Country
I.5 Consignee/Importer
Name
Address
Country
I.7 Country of origin
I.8 Region of origin
I.11 Place of dispatch
Name
Address
Country
I.13 Place of loading
--- ---
I.15 Means of transport
☐ Aircraft
☐ Railway
Identification
--- ---
I.18 Transport conditions
I.19 Container number/Seal number
Container No
I.20 Certified as or for
--- ---
I.21 ☐ For transit
Third country
--- ---
I.24 Total number of packages
--- ---
I.27 Description of consignment
CN code Species
Type

Part II:   Certification

COUNTRY COUNTRY Certificate model EQUI-OOCYTES-EMB-B-ENTRY Certificate model EQUI-OOCYTES-EMB-B-ENTRY Certificate model EQUI-OOCYTES-EMB-B-ENTRY Certificate model EQUI-OOCYTES-EMB-B-ENTRY
II. Health information II.a Certificate reference II.b IMSOC reference

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.