Commission Implementing Regulation (EU) 2025/243 of 30 January 2025 amending Annex I to Implementing Regulation (EU) 2021/403 as regards model animal health certificates for movements between Member States of consignments of certain categories of terrestrial animals and germinal products thereof

Type Implementing Regulation
Publication 2025-02-07
State In force
Text As published
Department European Commission, SANTE
Source EUR-Lex
articles 2

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: (1) either [II.1. The semen of [ovine] (1) [caprine] (1) animals described in Part I: II.1.1. has been collected, processed and stored, and dispatched from the semen collection centre (2) which is approved and kept in a register by the competent authority; II.1.2. has been collected, processed and stored, and dispatched from the semen collection centre which complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Part 1 of Annex I to Commission Delegated Regulation (EU) 2020/686; (1) either [II.1.3. is dispatched from the semen collection centre or a zone not subject to movement restrictions affecting ovine and caprine animals and established for reasons of listed diseases relevant for those species or diseases subject to emergency measures relevant for those species, or those restrictions do not apply to this semen because it was collected before the restrictions were established, and has not been in contact with other semen of a lower health status for an adequate period.]] (1) or [II.1.3. is dispatched from the semen collection centre or a zone subject to movement restrictions affecting ovine and caprine animals species and established for … (3), but derogations from movement restrictions have been granted, and: (1) [it complies with the requirements set out in … (4);]]] (1) [and in particular, it is … (5).]]] (1) or [II.1. The semen of [ovine] (1) [caprine] (1) animals described in Part I has been collected, processed and stored, and dispatched from: (1) either [II.1.1. the establishment or a zone not subject to movement restrictions affecting ovine and caprine animals and established for reasons of listed diseases relevant for those species or diseases subject to emergency measures relevant for those species, and has not been in contact with other semen of a lower health status for an adequate period;] (1) or [II.1.1. the establishment or a zone subject to movement restrictions affecting ovine and caprine animals species and established for … (3), but derogations from movement restrictions have been granted, and: (1) [it complies with the requirements set out in … (4);]] (1) [and in particular, it is … (5).]] II.1.2. the establishment where the donor animals are kept as referred to in Article 13 of Delegated Regulation (EU) 2020/686, and: II.1.2.1. the operator obtained the prior consent of the competent authority of the Member State of destination to accept the consignment; II.1.2.2. the donor animals have been clinically examined by a veterinarian prior to the date of semen collection; II.1.2.3. the operator keeps records at the establishment which include at least the information provided for in Article 8(1), point (a), of Delegated Regulation (EU) 2020/686.] II.2. The semen described in Part I is intended for artificial reproduction and was obtained from donor animals which: II.2.1. have been born and remained since birth in the Union, or have entered the Union in accordance with the requirements for entry into the Union; II.2.2. come, before the date of commencement of the quarantine referred to in point II.2.6, from establishments in a Member State or zone thereof, or from establishments under official control by the competent authority in a third country or territory, or a zone thereof: II.2.2.1. situated in an area where foot and mouth disease has not been reported within a 10-km radius centred on the establishment for at least 30 days and in which foot and mouth disease has not been reported during at least 3 months, and (1) either [the donor animals were not vaccinated against foot and mouth disease;] (1) or [the donor animals were vaccinated against foot and mouth disease during 12 months prior to the date of collection of the semen but not during the last 30 days immediately prior to the date of collection of the semen, and 5 % (with a minimum of five straws) of each quantity of semen taken from the donor animals at any time is submitted to a virus isolation test for foot and mouth disease with negative results;] II.2.2.2. free from infection with Brucella abortus, B. melitensis and B. suis and the donor animals have never been kept previously in any establishment of a lower health status; (1) (6) [II.2.2.3. in which infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has not been reported during the last 42 days;] (1) (7) [II.2.2.3. in which surveillance for infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has been carried out on the caprine animals kept in the establishments during at least 12 months, as referred to in Article 15(3) of Commission Delegated Regulation (EU) 2020/688, and in case, during this period, infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has been reported in caprine animals kept in the establishment, measures were taken in accordance with Part 1, point 3, of Annex II to that Delegated Regulation;] II.2.2.4. in which surra (Trypanosoma evansi) has not been reported during the last 30 days, and (1) either [surra has not been reported in the establishments during the last 2 years;] (1) or [surra has been reported in the establishments during the last 2 years and following the date of the last outbreak, the affected establishments have remained under movement restrictions until the date on which the infected animals have been removed from the establishments, and the remaining animals in the establishments have been subjected to a test for surra with one of the diagnostic methods provided for in Part 3 of Annex I to Delegated Regulation (EU) 2020/688, carried out, with negative results, on samples taken at least 6 months following the date on which the infected animals have been removed from the establishments;] (1) (6) [II.2.2.5. in which ovine epididymitis (Brucella ovis) has not been reported during the last 12 months;] (1) (11) [II.2.2.6. where, during the last 60 days prior to their stay in the quarantine accommodation referred to in point II.2.6, they have been subjected, with negative results, to a serological test for ovine epididymitis (Brucella ovis), or any other test for ovine epididymitis (Brucella ovis) of an equivalent documented sensitivity and specificity, as required in accordance with Part 3, Chapter I, point 1(b), of Annex II to Delegated Regulation (EU) 2020/686;] II.2.3. did not show symptoms or clinical signs of transmissible animal diseases on the day of their admission to a semen collection centre and on the date of collection of the semen; II.2.4. are individually identified as provided for in Article 45(2) or (4), or Article 46(1) of Commission Delegated Regulation (EU) 2019/2035; II.2.5. for at least 30 days prior to the date of first collection of the semen and during the collection period: II.2.5.1. were kept in establishments situated in a zone not subject to movement restrictions established due to the occurrence of foot and mouth disease, infection with rinderpest virus, infection with Rift Valley fever virus, infection with peste des petits ruminants virus, sheep pox and goat pox or contagious caprine pleuropneumonia, or of an emerging disease relevant for ovine and caprine animals; II.2.5.2. were kept in a single establishment where infection with Brucella abortus, B. melitensis and B. suis, infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis), rabies, anthrax, surra (Trypanosoma evansi), infection with epizootic haemorrhagic disease virus, infection with bluetongue virus (serotypes 1-24) and, in case of ovine animals and those caprine animals which are kept together with ovine animals, ovine epididymitis (Brucella ovis) have not been reported; II.2.5.3. were not in contact with animals from establishments situated in a zone subject to movement restrictions due to the occurrence of diseases referred to in point II.2.5.1 or from establishments which do not meet the conditions referred to in point II.2.5.2; II.2.5.4. were not used for natural breeding; II.2.6. have been subjected to a quarantine for at least 28 days in quarantine accommodation, where only other cloven-hoofed animals with at least the same health status were present, which on the day of admission of the donor animals to the semen collection centre complied with the following conditions: II.2.6.1. it was situated in a zone not subject to movement restrictions established due to diseases referred to in point II.2.5.1 or it was under derogation as referred to in point II.1.1, if applicable; II.2.6.2. none of the diseases referred to in point II.2.5.2 has been reported for at least 30 days; II.2.6.3. it was situated in an area where foot and mouth disease has not been reported within a 10-km radius centred on the quarantine accommodation for at least 30 days; II.2.6.4. it has had no outbreak of foot and mouth disease reported during at least 3 months preceding the date of admission of the donor animals into the semen collection centre; II.2.7. were kept in the semen collection centre: II.2.7.1. which was situated in a zone not subject to movement restrictions established due to diseases referred to in point II.2.5.1 or it was under derogation as referred to in point II.1.1, if applicable; II.2.7.2. where none of the diseases referred to in point II.2.5.2 has been reported for at least 30 days prior to the date of collection of the semen, and (1) (9) either [at least 30 days following the date of the collection;] (1) (10) or [until the date of departure of the consignment of semen to another Member State;] II.2.7.3. situated in an area where foot and mouth disease has not been reported within a 10-km radius centred on the semen collection centre for at least 30 days; and (1) (9) either [free from foot and mouth disease for at least 3 months prior to the date of collection of the semen and 30 days from the date of collection;] (1) (10) or [free from foot and mouth disease for at least 3 months prior to the date of collection of the semen and until the date of dispatch of the consignment of semen to another Member State and the donor animals have been kept at that semen collection centre for a continuous period of at least 30 days immediately prior to the date of collection of the semen;] II.2.8. comply with at least one of the following conditions as regards infection with bluetongue virus (serotypes 1-24): (1) either [II.2.8.1. they have been kept for at least 60 days prior to and during collection of the semen in a Member State or zone thereof free from infection with bluetongue virus (serotypes 1-24) where no case of infection with bluetongue virus (serotypes 1-24) in the targeted animal population has been confirmed during the last 24 months;] (1) or [II.2.8.2. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to and during collection of the semen, in a Member State or zone thereof with an approved eradication programme against infection with bluetongue virus (serotypes 1-24);] (1) or [II.2.8.3. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to and during collection of the semen, in a Member State or zone thereof where the competent authority of the place of origin of the consignment of semen has obtained the prior written consent of the competent authority of the Member State of destination to the conditions for establishment of that seasonally disease-free zone and to accept the consignment of semen;] (1) and/or [II.2.8.4. they have been kept in a vector protected establishment for at least 60 days prior to and during collection of the semen;] (1) and/or [II.2.8.5. they have been subjected to a serological test to detect antibodies to the bluetongue virus serotypes 1-24, with negative results, between 28 and 60 days from the date of each collection of the semen;] (1) and/or [II.2.8.6. they have been subjected to an agent identification test for bluetongue virus (serotypes 1-24), with negative results, on blood samples taken at commencement and final collection of the semen and during collection of the semen at intervals of at least every 7 days, in the case of the virus isolation test, or of at least every 28 days, in the case of PCR;] II.2.9. comply with at least one of the following conditions as regards infection with epizootic haemorrhagic disease virus (EHDV): (1) either [II.2.9.1. they have been kept for at least 60 days prior to and during collection of the semen in a Member State or zone thereof where EHDV has not been reported within a radius of 150 km of the establishment for at least 2 years;] (1) or [II.2.9.2. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to and during collection of the semen;] (1) and/or [II.2.9.3. they have been kept in a vector protected establishment for at least 60 days prior to and during collection of the semen;] (1) or [II.2.9.4. were resident in the Member State in which according to official findings the following serotypes of EHDV exist: … and have been subjected with negative results in each case to the following tests carried out in an official laboratory: (1) either [II.2.9.4.1. a serological test to detect antibodies to EHDV, with negative results, at least every 60 days throughout the collection period and between 28 and 60 days from the date of the final collection of the semen;]] (1) and/or [II.2.9.4.2. an agent identification test for EHDV, with negative results, on blood samples taken at the commencement and final collection of the semen and during the collection of the semen at intervals of at least every 7 days, in the case of virus isolation test, or of at least every 28 days, in the case of PCR;]] (1) (8) [II.2.10. have been subjected to the following tests, carried out on samples taken within 30 days prior to the date of commencement of the quarantine referred to in point II.2.6, with negative results, required in accordance with Part 3, Chapter I, point 1(c), of Annex II to Delegated Regulation (EU) 2020/686: II.2.10.1. for infection with Brucella abortus, B. melitensis and B. suis, a serological test referred to in Part 1, point 1, of Annex I to Delegated Regulation (EU) 2020/688; (1) (11) [II.2.10.2. for ovine epididymitis (Brucella ovis), a serological test or any other test with an equivalent documented sensitivity and specificity;] II.2.11. have been subjected to the following tests, carried out on samples taken at least 21 days after the date of commencement of the quarantine referred to in point II.2.6, with negative results, required in accordance with Part 3, Chapter I, point 1(d), of Annex II to Delegated Regulation (EU) 2020/686: II.2.11.1. for infection with Brucella abortus, B. melitensis and B. suis, a serological test referred to in Part 1, point 1, of Annex I to Delegated Regulation (EU) 2020/688; (1) (11) [II.2.11.2. for ovine epididymitis (Brucella ovis), a serological test or any other test with an equivalent documented sensitivity and specificity;] II.2.12. have been subjected at semen collection centre, at least once a year, to the following compulsory routine tests, required in accordance with Part 3, Chapter I, point 2, of Annex II to Delegated Regulation (EU) 2020/686: II.2.12.1. for infection with Brucella abortus, B. melitensis and B. suis, a serological test referred to in Part 1, point 1, of Annex I to Delegated Regulation (EU) 2020/688; (1) (11) [II.2.12.2. for ovine epididymitis (Brucella ovis), a serological test or any other test with an equivalent documented sensitivity and specificity;]] (1) (12) [II.2.13. have been subjected to the following tests, carried out on samples taken within 30 days prior to collection of the semen, with negative results: II.2.13.1. for infection with Brucella abortus, B. melitensis and B. suis, a serological test referred to in Part 1, point 1, of Annex I to Delegated Regulation (EU) 2020/688; (1) (11) [II.2.13.2. for ovine epididymitis (Brucella ovis), a serological test or any other test with an equivalent documented sensitivity and specificity.]] II.3. The semen described in Part I: (1) (8) [II.3.1. has been collected, processed and stored in accordance with animal health requirements set out in Part 1, points 1 and 2, of Annex III to Delegated Regulation (EU) 2020/686;] II.3.2. is placed in straws or other packages on which the mark is applied in accordance with requirements provided for in Article 10 of Delegated Regulation (EU) 2020/686 and that mark is indicated in box I.30; II.3.3. is transported in a container which: II.3.3.1. was sealed and numbered prior to the date of dispatch from the semen collection centre under responsibility of the centre veterinarian, or by an official veterinarian, and the seal bears the number as indicated in box I.19; II.3.3.2. has been cleaned and either disinfected or sterilised before use, or is single-use container; (1) (9) [II.3.3.3. has been filled in with a cryogenic agent which has not been previously used for other products;] (1) either [II.3.4. was collected from animals which have been kept continuously since birth on a holding or holdings recognised as having a negligible or controlled risk of classical scrapie in accordance with Chapter A, Section A, point 1, of Annex VIII to Regulation (EC) No 999/2001 of the European Parliament and of the Council, except during the period when they were kept at a semen collection centre that complied during that period with the conditions set out in Chapter A, Section A, point 1.3(c)(iv), of Annex VIII to Regulation (EC) No 999/2001.]] (1) or [II.3.4. was collected from animals which have been kept continuously for the last 3 years before the collection on a holding or holdings which has/have complied for the last 3 years before the collection with the requirements laid down in Chapter A, Section A, points 1.3(a) to (f), of Annex VIII to Regulation (EC) No 999/2001, except during the period when they were kept at a semen collection centre that complied during that period with the conditions set out in Chapter A, Section A, point 1.3(c)(iv), of Annex VIII to Regulation (EC) No 999/2001.]] (1) or [II.3.4. was collected from animals which have been kept continuously since birth in a Member State or zone of a Member State listed in Chapter A, Section A, point 2.3, of Annex VIII to Regulation (EC) No 999/2001 as having a negligible risk status for classical scrapie.]] (1) or [II.3.4. was collected from ovine animals of the ARR/ARR prion protein genotype.]] (1) (15) or [II.3.4. was collected from caprine animals carrying at least one of the K222, D146 or S146 alleles.]] (1) (13) [II.4. Where an antibiotic or mixture of antibiotics was added to the semen described in Part I: II.4.1. The following antibiotic or mixture of antibiotics has been added to the semen after final dilution, or is contained in the used semen diluents: … (14); II.4.2. Immediately after the addition of the antibiotic(s), and before any possible freezing, the diluted semen was kept at a temperature of at least 5 °C for not less than 45 minutes, or under a time-temperature regime with a documented equivalent bactericidal activity.] Notes: 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 2 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 or, in case of an establishment referred to in Article 13 of Delegated Regulation (EU) 2020/686, the unique registration number and address of the establishment of dispatch of the consignment of semen. 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.26 : Total number of packages shall correspond to the number of containers. Box reference I.30 : “Species”: Select amongst “ Ovis aries ” or “ Capra hircus ” as appropriate. “Type”: Indicate semen. “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where the semen of the consignment is placed. “Date of collection/production”: Indicate the date on which the semen of the consignment was collected. “Approval or registration number of plant/establishment/centre”: Indicate the unique approval number of the semen collection centre or, in the case of an establishment as referred to in Article 13 of Delegated Regulation (EU) 2020/686, the unique registration number of the establishment where the semen of the consignment was collected. “Quantity”: Indicate the number of straws or other packages with the same mark. “Test”: For BTV-test, indicate “point II.2.8.5” or “point II.2.8.6”, or both, and for EHD-test, indicate “point II.2.9.4.1” or “point II.2.9.4.2”, or both, if relevant. Part II: (1) Delete if not applicable. (2) Only semen collection centres approved by the competent authority and included in the register referred to in Article 101(1), point (b), of Regulation (EU) 2016/429 of the European Parliament and of the Council and Article 7 of Delegated Regulation (EU) 2020/686. (3) Insert the name of the disease(s). (4) Insert the specific reference to the article(s), title, and number of the relevant legal act(s) adopted by the Commission providing for those requirements. (5) Insert the specific attestation(s) provided for in and required by the relevant legal act(s) adopted by the Commission, as referred to in Article 159(2), points (a), (b) and (c), of Regulation (EU) 2016/429. (6) Applicable for ovine animals. (7) Applicable for caprine animals. (8) Applicable for semen collected at a semen collection centre. (9) Applicable for frozen semen. (10) Applicable for fresh and chilled semen. (11) Applicable for ovine animals and for those caprine animals which are kept together with ovine animals. (12) Applicable for semen collected at an establishment where the donor animals are kept as referred to in Article 13 of Delegated Regulation (EU) 2020/686. (13) Mandatory attestation in case antibiotic(s) was/were added. (14) Insert the name(s) of the antibiotic(s) added and its (their) concentration or the commercial name of the semen diluent containing antibiotic(s). (15) Alternative applicable from 14 April 2024.
Official veterinarian Official veterinarian Official veterinarian Official veterinarian
Name (in capital letters) Qualification and title
Local Control Unit name Local Control Unit code
Date
Stamp Signature’

;

  • (7) Chapter 33 is replaced by the following:

‘CHAPTER 33

MODEL ANIMAL HEALTH CERTIFICATE FOR THE MOVEMENT BETWEEN MEMBER STATES OF CONSIGNMENTS OF OOCYTES AND EMBRYOS OF OVINE AND CAPRINE 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) 2020/686 AFTER 20 APRIL 2021, DISPATCHED BY THE EMBRYO COLLECTION OR PRODUCTION TEAM BY WHICH THE OOCYTES OR EMBRYOS WERE COLLECTED OR PRODUCED (MODEL “OV/CAP-OOCYTES-EMB-A-INTRA”)

Part I:   Description of consignment

EUROPEAN UNION INTRA
I.1 Consignor I.2 IMSOC reference
Name I.2a Local reference
Address I.3 Central Competent Authority QR CODE
Address I.3 Central Competent Authority
Country ISO country code I.4 Local Competent Authority
I.5 Consignee I.6 Operator conducting assembly operations independently of an establishment Operator conducting assembly operations independently of an establishment Operator conducting assembly operations independently of an establishment
Name Name Name Registration No
Address Address Address
Country ISO country code Country Country ISO country code
I.7 Country of origin ISO country code I.9 Country of destination Country of destination ISO country code
I.8 Region of origin Code I.10 Region of destination Region of destination Code
I.11 Place of dispatch I.12 Place of destination Place of destination
Name Registration/Approval No Name Name Registration/Approval No
Address Address Address
Country ISO country code Country Country ISO country code
I.13 Place of loading Place of loading I.14 Date and time of departure Date and time of departure Date and time of departure
I.15 Means of transport I.16 Transporter Transporter
☐ Vessel ☐ Aircraft Name Registration/Authorisation No
☐ Vessel ☐ Aircraft Address
☐ Railway ☐ Road vehicle Country ISO country code
☐ Railway ☐ Road vehicle I.17 Accompanying documents Accompanying documents
Identification ☐ Other Type Code
Document Document Country ISO country code
Document Document Commercial document reference
I.18 Transport conditions ☐ Ambient ☐ Chilled ☐ Frozen
I.19 Container number/Seal number Container number/Seal number Container number/Seal number Container number/Seal number
Container No Container No Seal No
I.20 Certified as or for Certified as or for Certified as or for Certified as or for
☐ Further keeping ☐ Further keeping ☐ Slaughter ☐ Confined establishment ☐ Germinal products
☐ Registered equine animal ☐ Registered equine animal ☐ Travelling circus/animal act ☐ Exhibition ☐ Event or activity near borders
☐ Release into the wild ☐ Release into the wild ☐ Dispatch centre ☐ Relaying area/purification centre ☐ Ornamental aquaculture establishment
☐ Further processing ☐ Further processing ☐ Organic fertilizers and soil improvers ☐ Technical use ☐ Quarantine or similar establishment
☐ Products for human consumption ☐ Products for human consumption ☐ Pollination ☐ Live aquatic animals for human consumption ☐ Other
I.21 ☐ For transit through a third country ☐ For transit through a third country
Third country ISO country code
Exit point BCP code
Entry point BCP code
I.22 ☐ For transit through Member State(s) ☐ For transit through Member State(s) I.23 ☐ For export ☐ For export
Member State ISO country code Third country ISO country code
Member State ISO country code Exit point BCP code
Member State ISO country code
I.24 Estimated journey time I.25 Journey log ☐ yes ☐ no
I.26 Total number of packages I.27 Total quantity Total quantity Total quantity
I.28 Total net weight/gross weight (kg) I.29 Total space foreseen for the consignment Total space foreseen for the consignment Total space foreseen for the consignment
I.30 Description of consignment Description of consignment Description of consignment Description of consignment Description of consignment Description of consignment Description of consignment Description of consignment
CN code CN code Species Subspecies/Category Sex Identification system Identification number Age Quantity
Type
Region of origin Region of origin Cold store Identification mark Type of packaging Net weight
Slaughterhouse Slaughterhouse Treatment type Nature of commodity Number of packages Batch No
Date of collection/production Manufacturing plant Approval or registration number of plant/establishment/centre Test

Part II:   Certification

EUROPEAN UNION EUROPEAN UNION Certificate model OV/CAP-OOCYTES-EMB-A-INTRA Certificate model OV/CAP-OOCYTES-EMB-A-INTRA Certificate model OV/CAP-OOCYTES-EMB-A-INTRA Certificate model OV/CAP-OOCYTES-EMB-A-INTRA
II. Health information II.a Certificate reference II.b IMSOC reference
I, the undersigned official veterinarian, hereby certify that: (1)[II.1. The [oocytes] (1) [in vivo derived embryos] (1) of [ovine] (1) [caprine] (1) animals described in Part I have been collected, processed and stored, and dispatched by the embryo collection team (2) which: II.1.1. is approved and kept in a register by the competent authority; II.1.2. 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.1. The [oocytes] (1) [in vitro produced embryos] (1) [micromanipulated embryos] (1) of [ovine] (1) [caprine] (1) animals described in Part I have been collected or produced, processed and stored, and dispatched by the embryo production team (2) which: II.1.1. is approved and kept in a register by the competent authority; II.1.2. 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.2. The consignment consists of [oocytes] (1) [embryos] (1) of the [ovine] (1) [caprine] (1) species which, as regards classical scrapie, (1) either [were collected from animals which have been kept continuously since birth on a holding or holdings recognised as having a negligible or a controlled risk of classical scrapie in accordance with Chapter A, Section A, point 1, of Annex VIII to Regulation (EC) No 999/2001 of the European Parliament and of the Council.] (1) or [were collected from animals which have been kept continuously for the last 3 years before the collection on a holding or holdings which have complied for the last 3 years before collection with the requirements laid down in Chapter A, Section A, points 1.3(a) to (f), of Annex VIII to Regulation (EC) No 999/2001.] (1) or [were collected from animals which have been kept continuously since birth in a Member State or zone of a Member State listed in Chapter A, Section A, point 2.3, of Annex VIII to Regulation (EC) No 999/2001 as having a negligible risk status for classical scrapie.] (1) or [were collected from ovine animals carrying at least one ARR allele.] (1) (15) or [were collected from caprine animals carrying at least one of the K222, D146 or S146 alleles.] II.3. The [oocytes] (1) [embryos] (1) described in Part I are intended for artificial reproduction and were obtained from donor animals which: II.3.1. have been born and remained since birth in the Union, or have entered the Union in accordance with the requirements for entry into the Union; II.3.2. come from establishments in a Member State or zone thereof, or from establishments under official control by the competent authority in a third country or territory, or a zone thereof: II.3.2.1. free from infection with Brucella abortus, B. melitensis and B. suis and have never been kept previously in any establishment of a lower health status; (1) (6) [II.3.2.2. in which infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has not been reported during the last 42 days prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1);] (1) (7) [II.3.2.2. in which surveillance for infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has been carried out on the caprine animals kept in the establishments during at least 12 months prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1), as referred to in Article 15(3) of Commission Delegated Regulation (EU) 2020/688, and in case, during this period, infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has been reported in caprine animals kept in the establishment, measures were taken in accordance with Part 1, point 3, of Annex II to that Delegated Regulation;] II.3.2.3. in which surra (Trypanosoma evansi) has not been reported during the last 30 days prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1), and (1) either [surra has not been reported in the establishments during the last 2 years prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1);] (1) or [surra has been reported in the establishments during the last 2 years prior to the date of [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and following the date of the last outbreak, the affected establishments have remained under movement restrictions until the date on which the infected animals have been removed from the establishment, and the remaining animals in the establishment have been subjected to a test for surra with one of the diagnostic methods provided for in Part 3 of Annex I to Delegated Regulation (EU) 2020/688, carried out, with negative results, on samples taken at least 6 months following the date on which the infected animals have been removed from the establishment;] II.3.3. 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.3.4. are individually identified as provided for in Article 45(2) or (4), or Article 46(1) or (3) of Commission Delegated Regulation (EU) 2019/2035; II.3.5. for at least 30 days prior to the date of first [collection] (1) [production] (1) of the [oocytes] (1) [embryos] (1) and during the collection period: II.3.5.1. were kept in establishments situated in a zone not subject to movement restrictions established due to the occurrence of foot and mouth disease, infection with rinderpest virus, infection with Rift Valley fever virus, infection with peste des petits ruminants virus, sheep pox and goat pox or contagious caprine pleuropneumonia, or of an emerging disease relevant for ovine and caprine animals; II.3.5.2. were kept in a single establishment where infection with Brucella abortus, B. melitensis and B. suis, infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis), rabies, anthrax, surra (Trypanosoma evansi), infection with epizootic haemorrhagic disease virus, infection with bluetongue virus (serotypes 1-24) and, in case of ovine animals and those caprine animals which are kept together with ovine animals, ovine epididymitis (Brucella ovis) have not been reported; II.3.5.3. were not in contact with animals from establishments situated in a zone subject to movement restrictions due to the occurrence of diseases referred to in point II.3.5.1 or from establishments which do not meet the conditions referred to in point II.3.5.2; II.3.5.4. were not used for natural breeding; II.3.6. comply with the following conditions as regards foot and mouth disease: II.3.6.1. they come from establishments: II.3.6.1.1. situated in an area where foot and mouth disease has not been reported within a 10-km radius centred on the establishment for at least 30 days immediately prior to the date of collection of the [oocytes] (1) [embryos] (1); II.3.6.1.2. in which foot and mouth disease has not been reported during at least 3 months immediately prior to the date of collection of the [oocytes] (1) [embryos] (1); (1) either [II.3.6.2. they were not vaccinated against foot and mouth disease;] (1) (5) or [II.3.6.2. they were vaccinated against foot and mouth disease during 12 months prior to the date of collection or production of the embryos and: II.3.6.2.1. 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.3.6.2.2. 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.3.6.2.3. prior to the date of freezing, the embryos have been subjected to trypsin washing carried out in accordance with the recommendations of the IETS Manual (6); II.3.6.2.4. the embryos were stored deep frozen for at least 30 days from the date of collection, and during this period the donor animals have not shown clinical signs of foot and mouth disease;] II.3.7. comply with at least one of the following conditions as regards infection with bluetongue virus (serotypes 1-24): (1) either [II.3.7.1. they have been kept for at least 60 days prior to the date and during the period of collection of the [oocytes] (1) [embryos] (1) in a Member State or zone thereof free from infection with bluetongue virus (serotypes 1-24) where no case of infection with bluetongue virus (serotypes 1-24) has been confirmed in the targeted animal population during the preceding 24 months;] (1) or [II.3.7.2. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to the date and during the period of collection of the [oocytes] (1) [embryos] (1), in a Member State or zone thereof with an approved eradication programme against infection with bluetongue virus (serotypes 1-24);] (1) or [II.3.7.3. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to the date and during the period of collection of the [oocytes] (1) [embryos] (1), in a Member State or zone thereof where the competent authority of the place of origin of the consignment of [oocytes] (1) [embryos] (1) has obtained the prior written consent of the competent authority of the Member State of destination to the conditions for establishment of that seasonally disease-free zone and to accept the consignment of [oocytes] (1) [embryos] (1);] (1) and/or [II.3.7.4. they have been kept in a vector protected establishment for at least 60 days prior to the date and during the period of collection of the [oocytes] (1) [embryos] (1);] (1) and/or [II.3.7.5. they have been subjected to a serological test to detect antibodies to the bluetongue virus serotypes 1-24, with negative results, between 28 and 60 days from the date of each collection of the [oocytes] (1) [embryos] (1);] (1) and/or [II.3.7.6. they have been subjected to an agent identification test for bluetongue virus (serotypes 1-24), with negative results, on blood sample taken on the day of collection of the [oocytes] (1) [embryos] (1);] II.3.8. comply with at least one of the following conditions as regards infection with epizootic haemorrhagic disease virus (EHDV): (1) either [II.3.8.1. they have been kept for at least 60 days prior to the date and during the period of collection of the [oocytes] (1) [embryos] (1) in a Member State or zone thereof where EHDV has not been reported within a radius of 150 km of the establishment for at least 2 years;] (1) or [II.3.8.2. they have been kept in a seasonally disease-free zone, during the seasonally disease-free period, for at least 60 days prior to the date and during the period of collection of the [oocytes] (1) [embryos] (1);] (1) and/or [II.3.8.3. they have been kept in a vector protected establishment for at least 60 days prior to the date and during the period of collection of the [oocytes] (1) [embryos] (1);] (1) or [II.3.8.4. were resident in a Member State or zone thereof in which according to official findings the following serotypes of EHDV exist: … and have been subjected with negative results in each case to the following tests carried out in an official laboratory: (1) either [II.3.8.4.1. a serological test to detect antibodies to EHDV, with negative results, on blood sample taken between 28 and 60 days from the date of the collection of the [oocytes] (1) [embryos] (1);]] (1) and/or [II.3.8.4.2. an agent identification test for EHDV, with negative results, on blood sample taken on the date of collection of the [oocytes] (1) [embryos] (1).]] II.4. The [oocytes] (1) [embryos] (1) described in Part I: II.4.1. 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.4.2. are placed in straws or other packages on which the mark is applied in accordance with requirements provided for in Article 10 of Delegated Regulation (EU) 2020/686 and that mark is indicated in box I.30; II.4.3. are transported in a container which: II.4.3.1. 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.4.3.2. has been cleaned and either disinfected or sterilised before use, or is single-use container; (1) (7) [II.4.3.3. has been filled in with a cryogenic agent which has not been previously used for other products;] (1) (8) [II.4.4. are placed in straws or other packages which are securely and hermetically sealed; II.4.5. 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) (9) [II.5. 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 and storage, or storage of semen by the competent authority of a Member State or by the competent authority of a third country or territory, or zone thereof listed in Annex X to Commission Implementing Regulation (EU) 2021/404, and which was collected, processed and stored in accordance with the requirements of Part 3, Chapter I, and Part 5, Chapters II and III, of Annex II, and of Part 1 of Annex III to Delegated Regulation (EU) 2020/686.] (1) (10) [II.6. The following antibiotic or mixture of antibiotics (11) has been added to the collection, processing, washing or storage media: …] II.7. The [oocytes] (1) [embryos] (1) described in Part I are dispatched by (1) either [an [embryo collection team] (1) [embryo production team] (1) or from a zone not subject to movement restrictions affecting ovine and caprine animals and established for reasons of listed diseases relevant for those species or diseases subject to emergency measures relevant for those species or those restrictions do not apply to these oocytes or embryos because they were collected before the restrictions were established, and they have not been in contact with other oocytes or embryos of a lower health status for an adequate period.] (1) or [an [embryo collection team] (1) [embryo production team] (1) or from a zone subject to movement restrictions affecting ovine and caprine animals and established for … (12), but derogations from movement restrictions have been granted, and: (1) [they comply with the requirements set out in … (13);]] (1) [and, in particular, they are … (14).]] Notes: 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 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 2 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. 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.26 : Total number of packages shall correspond to the number of containers. Box reference I.30 : “Type”: Specify if in vivo derived embryos, in vivo derived oocytes, in vitro produced embryos or micromanipulated embryos. “Species”: Select amongst “ Ovis aries ” or “ Capra hircus ” as appropriate. “Identification number”: Indicate the identification number of each donor animal. “Identification mark”: Indicate the mark on the straw or other packages where the oocytes or embryos of the consignment are placed. “Date of collection/production”: Indicate the date on which the 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 the oocytes or embryos of the consignment were collected or produced. “Quantity”: Indicate the number of straws or other packages with the same mark. “Test”: For BTV-test, indicate “point II.3.7.5” or “point II.3.7.6”, or both, and for EHD-test indicate “point II.3.8.4.1” or “point II.3.8.4.2”, or both, if relevant. Part II: (1) Delete if not applicable. (2) Only embryo collection or production teams approved by the competent authority and included in the register referred to in Article 101(1), point (b,) of Regulation (EU) 2016/429 of the European Parliament and of the Council and Article 7 of Delegated Regulation (EU) 2020/686. (3) Applicable for ovine animals. (4) Applicable for caprine animals. (5) Alternative available only for consignments 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 frozen oocytes or embryos. (8) Applicable for consignments where oocytes, in vivo derived embryos, in vitro produced embryos and micromanipulated embryos of ovine or caprine animals are placed and transported in one container. (9) Does not apply to oocytes. (10) Mandatory attestation in case antibiotic(s) was/were added. (11) Insert the name(s) of the antibiotic(s) added and its (their) concentration. (12) Insert the name of the disease(s). (13) Insert the specific reference to the article(s), title, and number of the relevant legal act(s) adopted by the Commission providing for those requirements. (14) Insert the specific attestation(s) provided for in and required by the relevant legal act(s) adopted by the Commission, as referred to in Article 159(2), points (a), (b) and (c), of Regulation (EU) 2016/429. (15) Alternative applicable from 14 April 2024.
Official veterinarian Official veterinarian Official veterinarian Official veterinarian
Name (in capital letters) Qualification and title
Local Control Unit name Local Control Unit code
Date
Stamp Signature’

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ELI: http://data.europa.eu/eli/reg_impl/2025/243/oj

ISSN 1977-0677 (electronic edition)

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