# L_2013172EN.01003201.xml

| 25.6.2013 | EN | Official Journal of the European Union | L 172/32 |
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25.6.2013

EN

Official Journal of the European Union

L 172/32

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COMMISSION IMPLEMENTING DECISION

of 19 June 2013

amending Annexes II, III and IV to Decision 2006/168/EC as regards certain veterinary certification requirements for imports into the Union of bovine embryos

(notified under document C(2013) 3704)

(Text with EEA relevance)

(2013/309/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (1), and in particular point (b) of the first subparagraph of Article 9(1) thereof,

Whereas:

| (1) | Commission Decision 2006/168/EC of 4 January 2006 establishing the animal health and veterinary certification requirements for imports into the Community of bovine embryos and repealing Decision 2005/217/EC (2) sets out in Annex I thereto the list of third countries from which Member States are to authorise imports of embryos of domestic animals of the bovine species (‘the embryos’). It also lays down additional guarantees as regards specific animal diseases to be provided by certain third countries listed in that Annex. |
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(1)

Commission Decision 2006/168/EC of 4 January 2006 establishing the animal health and veterinary certification requirements for imports into the Community of bovine embryos and repealing Decision 2005/217/EC (2) sets out in Annex I thereto the list of third countries from which Member States are to authorise imports of embryos of domestic animals of the bovine species (‘the embryos’). It also lays down additional guarantees as regards specific animal diseases to be provided by certain third countries listed in that Annex.

| (2) | Decision 2006/168/EC also provides that Member States are to authorise imports of embryos that comply with the animal health requirements set out in the model veterinary certificates in Annexes II, III and IV to that Decision. |
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(2)

Decision 2006/168/EC also provides that Member States are to authorise imports of embryos that comply with the animal health requirements set out in the model veterinary certificates in Annexes II, III and IV to that Decision.

| (3) | Israel is listed in Annex I to Decision 2006/168/EC as a country authorised for imports into the Union of in vivo derived and in vitro produced bovine embryos. However, for the past years there are no records of imports into the Union. |
| --- | --- |

(3)

Israel is listed in Annex I to Decision 2006/168/EC as a country authorised for imports into the Union of in vivo derived and in vitro produced bovine embryos. However, for the past years there are no records of imports into the Union.

| (4) | In November 2012, Israel notified to the World Organisation for Animal Health (OIE) the first cases of lumpy skin disease in dairy cows. In March 2013, Israel reported to the OIE that the disease continues to spread towards the south and west of the initial outbreak and has since affected more dairy herds. |
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(4)

In November 2012, Israel notified to the World Organisation for Animal Health (OIE) the first cases of lumpy skin disease in dairy cows. In March 2013, Israel reported to the OIE that the disease continues to spread towards the south and west of the initial outbreak and has since affected more dairy herds.

| (5) | Lumpy skin disease is a viral disease listed as compulsorily notifiable disease in Annex I to Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (3). Lumpy skin disease is currently not present in the Union. |
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(5)

Lumpy skin disease is a viral disease listed as compulsorily notifiable disease in Annex I to Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (3). Lumpy skin disease is currently not present in the Union.

| (6) | In accordance with Article 4.7.14 of the OIE Terrestrial Animal Health Code, lumpy skin disease is included in Category 4, which lists diseases or pathogenic agents for which studies have been done that indicate the risk of transmission via embryo transfer might not be negligible even if the embryos are properly handled between collection and transfer according to the Manual of the International Embryo Transfer Society. Union legislation on trade in and imports from third countries of bovine embryos is in line with that Manual. |
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(6)

In accordance with Article 4.7.14 of the OIE Terrestrial Animal Health Code, lumpy skin disease is included in Category 4, which lists diseases or pathogenic agents for which studies have been done that indicate the risk of transmission via embryo transfer might not be negligible even if the embryos are properly handled between collection and transfer according to the Manual of the International Embryo Transfer Society. Union legislation on trade in and imports from third countries of bovine embryos is in line with that Manual.

| (7) | Article 11.12.10 of the OIE Terrestrial Animal Health Code sets out recommendations with regard to the importation of embryos and oocytes of bovine animals from countries considered infected with lumpy skin disease. |
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(7)

Article 11.12.10 of the OIE Terrestrial Animal Health Code sets out recommendations with regard to the importation of embryos and oocytes of bovine animals from countries considered infected with lumpy skin disease.

| (8) | There are currently no requirements concerning lumpy skin disease in the model veterinary certificates set out in Annexes II, III and IV to Decision 2006/168/EC. There is therefore a risk that the disease will be introduced into the Union by importing embryos from third countries where lumpy skin disease is present. |
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(8)

There are currently no requirements concerning lumpy skin disease in the model veterinary certificates set out in Annexes II, III and IV to Decision 2006/168/EC. There is therefore a risk that the disease will be introduced into the Union by importing embryos from third countries where lumpy skin disease is present.

| (9) | It is therefore appropriate that animal health requirements relating to lumpy skin disease, in line with the recommendations set out in the Terrestrial Animal Health Code of the OIE, be included in the model veterinary certificates set out in Annexes II, III and IV to Decision 2006/168/EC. |
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(9)

It is therefore appropriate that animal health requirements relating to lumpy skin disease, in line with the recommendations set out in the Terrestrial Animal Health Code of the OIE, be included in the model veterinary certificates set out in Annexes II, III and IV to Decision 2006/168/EC.

| (10) | Annexes II, III and IV to Decision 2006/168/EC should therefore be amended accordingly. |
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(10)

Annexes II, III and IV to Decision 2006/168/EC should therefore be amended accordingly.

| (11) | To avoid any disruption of trade, the use of veterinary certificates issued in accordance with Decision 2006/168/EC in its version prior to the amendments introduced by this Decision should be authorised during a transitional period subject to certain conditions. |
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(11)

To avoid any disruption of trade, the use of veterinary certificates issued in accordance with Decision 2006/168/EC in its version prior to the amendments introduced by this Decision should be authorised during a transitional period subject to certain conditions.

| (12) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(12)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Annexes II, III and IV to Decision 2006/168/EC are replaced by the text set out in the Annex to this Decision.

Article 2

For a transitional period until 1 September 2013, Member States shall continue to authorise imports of consignments of embryos of domestic animals of the bovine species from third countries which are accompanied by a model veterinary certificate issued not later than 31 July 2013 in accordance with the models set out in Annexes II, III and IV to Decision 2006/168/EC in its version prior to the amendments introduced by this Decision.

Article 3

This Decision shall apply as of 1 August 2013.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 19 June 2013.

For the Commission

Tonio BORG

Member of the Commission

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(1)  
  OJ L 302, 19.10.1989, p. 1.

1

(2)  
  OJ L 57, 28.2.2006, p. 19.

2

(3)  
  OJ L 62, 15.3.1993, p. 69.

3

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ANNEX

‘ANNEX II

Model veterinary certificate for imports of in vivo derived embryos of domestic animals of the bovine species collected in accordance with Council Directive 89/556/EEC

Image 1

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

Name

Approval number

Address

I.12. Place of destination

Name

Address

Postal cod

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification

Documentary references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

05 11 99 85

I.20. Quantity

I.21.

I.22. Number of packages

I.23. Seal/Container No

I.24.

I.25. Commodities certified for:

Artificial reproduction

I.26. For transit through EU to third country

Third country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(Scientific name)

Breed

Category

Donor identity

Date of collection

Date of freezing

Approval number of the team

Quantity

Image 2

Part II: Certification

COUNTRY

In vivo derived bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

I, the undersigned, official veterinarian of the ... certify that:

(exporting country) (2)

II.1. The embryos to be exported:

II.1.1. were collected in the exporting country, which according to official findings:

II.1.1.1. was free from rinderpest during the 12 months immediately prior to their collection;

(1) either [II.1.1.2. was free from foot-and-mouth disease and lumpy skin disease during the 12 months immediately prior to their collection and did not carry out vaccination against foot-and-mouth disease or lumpy skin disease during that period.]

(1) or [II.1.1.2. was not free from foot-and-mouth disease or lumpy skin disease during the 12 months immediately prior to their collection or carried out vaccination against foot-and-mouth disease or lumpy skin disease during that period, and:

the embryos were not subjected to penetration of the zona pellucida,

the embryos were stored under approved conditions for at least 30 days immediately after their collection,

the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease or lumpy skin disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease or lumpy skin disease during the 30 days prior to, and at least the 30 days after, the embryos were collected.]

II.1.2. were collected by the embryo collection team (3) which:

has been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC;

which carried out the collection, processing, storing and transport of the embryos in accordance with Chapter II of Annex A to Directive 89/556/EEC;

is subject to inspection by an official veterinarian at least twice a year.

II.1.3. were collected and processed on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease in the 30 days immediately prior to their collection and until dispatch to the Union, in the case of fresh embryos, or during the 30 days after collection, in the case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.1.1.2.

II.1.4. from the time of collection until 30 days thereafter or, in the case of fresh embryos until the day of their dispatch to the Union, they were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease.

II.1.5. were collected from the donor females, which:

II.1.5.1. were located, during the 30 days immediately prior to collection, on premises situated in an area of at least 10 km radius centred on them, on which, according to official findings, there was no occurrence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease;

II.1.5.2. showed no clinical signs of disease on the day of collection;

II.1.5.3. spent the six months immediately prior to collection within the territory of the exporting country in no more than two herds:

which, according to official findings, were free from tuberculosis during that time,

which, according to official findings, were free from brucellosis during that time,

which were free from enzootic bovine leukosis or in which no bovine animal showed clinical signs of enzootic bovine leukosis during the previous three years,

in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months.

II.1.6. The embryos to be exported were conceived by artificial insemination using semen coming from semen collection or storage centres approved for the collection, processing and/or storage of semen by the competent authority of a third country or part thereof listed in Annex I to Implementing Decision 2011/630/EU (4) or by the competent authority of a Member State.

Image 3

COUNTRY

In vivo derived bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

Notes

Part I:

Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.

Box I.11: Place of origin shall correspond to the embryo collection team from which the embryos are dispatched to the Union and which is listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

Box I.22: Number of packages shall correspond to the number of containers.

Box I.23: Identification of container and seal number shall be indicated.

Box I.26: Fill in according to whether it is a transit or an import certificate.

Box I.27: Fill in according to whether it is a transit or an import certificate.

Box I.28: Species: select amongst ‘Bos taurus’, ‘Bison bison’ or ‘Bubalus bubalis’ as appropriate.

Category: select ‘in vivo derived embryos’.

Donor identity shall correspond to the official identification of the animal.

Date of collection shall be indicated in the following format: dd.mm.yyyy

Approval number of the team: shall correspond to the embryo collection team by which the embryos were collected, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

Part II:

(1) Delete as appropriate.

(2) Only third countries listed in Annex I to Decision 2006/168/EC.

(3) Only embryo collection teams listed in accordance with Article 8(2) of Directive 89/556/EEC on Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

(4) OJ L 247, 24.9.2011, p. 32.

The signature and the stamp must be in a different colour to that of the printing.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp:

‘ANNEX III

Model veterinary certificate for imports of in vitro produced embryos of domestic animals of the bovine species conceived using semen complying with Council Directive 88/407/EEC

Image 4

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

Name

Approval number

Address

I.12. Place of destination

Name

Address

Postal code

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification

Documentary references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

05 11 99 85

I.20. Quantity

I.21.

I.22. Number of packages

I.23. Seal/Container No

I.24.

I.25. Commodities certified for:

Artificial reproduction

I.26. For transit through EU to third country

Third country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(Scientific name)

Breed

Category

Dam identity

Sire identity

Date of freezing

Approval number of the team

Quantity

Image 5

Part II: Certification

COUNTRY

In vitro produced bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

I, the undersigned, official veterinarian of ... certify that:

(exporting country) (2)

II.1. The embryos to be exported:

II.1.1. were produced in the exporting country, which according to official findings:

II.1.1.1. was free from rinderpest during the 12 months immediately prior to their production;

(1) either [II.1.1.2. was free from foot-and-mouth disease and lumpy skin disease during the 12 months immediately prior to their production and did not carry out vaccination against foot-and-mouth disease or lumpy skin disease during that period.]

(1) or [II.1.1.2. was not free from foot-and-mouth disease or lumpy skin disease during the 12 months immediately prior to their production or carried out vaccination against foot-and-mouth disease or lumpy skin disease during that period, and

the embryos were produced without penetration of the zona pellucida,

the embryos were stored under approved conditions for at least 30 days immediately after their production,

the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease or lumpy skin disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease or lumpy skin disease during the 30 days prior to, and at least the 30 days after, the oocytes were collected.]

II.1.2. were produced by the embryo production team (3) which:

has been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC,

carried out the production, processing, storing and transport in accordance with Chapter II of Annex A to Directive 89/556/EEC,

is subject to inspection by an official veterinarian at least twice a year.

II.2. The oocytes used in the production of the embryos to be exported were collected on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease in the 30 days immediately prior to their collection and until their dispatch to the Union, in the case of fresh embryos, or during the 30 days after collection, in the case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.1.1.2.

II.3. From the time of collection of the oocytes until 30 days thereafter or, in the case of fresh embryos, until the day of dispatch, the embryos to be exported were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease.

II.4. The donors of oocytes used in the production of the embryos to be exported:

II.4.1. were located, during the 30 days immediately prior to collection of the oocytes, on premises situated in an area of at least 10-km radius on which, according to official findings, there was no occurrence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease;

II.4.2. showed no clinical signs of disease on the day of collection;

II.4.3. spent the six months immediately prior to collection within the territory of the exporting country in no more than two herds:

which, according to official findings, were free from tuberculosis during that time,

which, according to official findings, were free from brucellosis during that time,

which were free from enzootic bovine leukosis or in which no bovine animal showed clinical signs of enzootic bovine leukosis during the previous three years,

in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months;

(1) either [II.4.4. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the oocytes.]

Image 6

COUNTRY

In vitro produced bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

(1) or [II.4.4. were kept during a seasonally free period or protected from the vector for at least 60 days prior to, and during, the collection of the oocytes, and the embryos were produced without penetration of the zona pellucida, except if the donors underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results and the embryos were stored for at least 30 days.]

(1) or [II.4.4. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results, and the embryos were stored for at least 30 days.]

(1) or [II.4.4. underwent an agent identification test, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of collection or the day of slaughtering and giving negative results – the embryos having been produced, in the latter case, without penetration of the zona pellucida.]

II.5. The embryos to be exported were conceived by in vitro fertilisation using semen coming from semen collection or storage centres (4):

(1) either [II.5.1. approved in accordance with Article 5(1) of Directive 88/407/EEC and located in a Member State of the European Union, and the semen complies with the requirements of Directive 88/407/EEC.]

(1) or [II.5.1. approved in accordance with Article 9(1) of Directive 88/407/EEC and located in a third country or part thereof listed in Annex I to Implementing Decision 2011/630/EU, and the semen complies with the requirements set out in Section A of Part 1 of Annex II to that Decision.]

Notes

Part I:

Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.

Box I.11: Place of origin shall correspond to the embryo production team from which the embryos are dispatch to the Union and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

Box I.22: Number of packages shall correspond to the number of containers.

Box I.23: Identification of container and seal number shall be indicated.

Box I.26: Fill in according to whether it is a transit or an import certificate.

Box I.27: Fill in according to whether it is a transit or an import certificate.

Box I.28: Species: select amongst ‘Bos taurus’, ‘Bison bison’ or ‘Bubalus bubalis’ as appropriate.

Category: select ‘in vitro produced embryos’.

Dam identity shall correspond to the official identification of the animal.

Sire identity shall correspond to the official identification of the animal.

Date of freezing shall be indicated in the following format: dd.mm.yyyy

Approval number of the team: shall correspond to the embryo production team by which the embryos were produced, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

Part II:

(1) Delete as appropriate.

(2) Only third countries listed in Annex I to Decision 2006/168/EC.

(3) Only embryo production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

(4) Only semen collection centres listed in accordance with Article 5(2) and Article 9(2) of Directive 88/407/EEC on the Commission websites:

http://ec.europa.eu/food/animal/approved_establishments/establishments_vet_field_en.htm;

http://ec.europa.eu/food/animal/semen_ova/bovine/index_en.htm

The signature and the stamp must be in a different colour to that of the printing.

Image 7

COUNTRY

In vitro produced bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp:

‘ANNEX IV

Model veterinary certificate for imports of in vitro-produced embryos of domestic animals of the bovine species conceived using semen coming from semen collection or storage centres approved by the competent authority of the exporting country

Image 8

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

Name

Approval number

Address

I.12. Place of destination

Name

Address

Postal code

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification

Documentary references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

05 11 99 85

I.20. Quantity

I.21.

I.22. Number of packages

I.23. Seal/Container No

I.24.

I.25. Commodities certified for:

Artificial reproduction

I.26. For transit through EU to third country

Third country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(Scientific name)

Breed

Category

Dam identity

Sire identity

Date of freezing

Approval number of the team

Quantity

Image 9

Part II: Certification

COUNTRY

In vitro produced bovine embryos using semen from semen centres approved by the exporting country

II. Health information

II.a. Certificate reference No

II.b.

I, the undersigned, official veterinarian of ... certify that:

(exporting country) (2)

II.1. The embryos to be exported

II.1.1. were produced in the exporting country, which according to official findings:

II.1.1.1. was free from rinderpest during the 12 months immediately prior to their production;

(1) either [II.1.1.2. was free from foot-and-mouth disease and lumpy skin disease during the 12 months immediately prior to their production and did not carry out vaccination against foot-and-mouth disease or lumpy skin disease during that period.]

(1) or [II.1.1.2. was not free from foot-and-mouth disease or lumpy skin disease during the 12 months immediately prior to their production or carried out vaccination against foot-and-mouth disease or lumpy skin disease during that period, and

the embryos were produced without penetration of the zona pellucida,

the embryos were stored under approved conditions for at least 30 days immediately after their production,

the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease or lumpy skin disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease or lumpy skin disease during the 30 days prior to, and at least the 30 days after, the oocytes were collected.]

II.1.2. were produced by the embryo production team (3) which:

has been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC;

carried out the production, processing, storing and transport of the embryos in accordance with Chapter II of Annex A to Directive 89/556/EEC;

is subject to inspection by an official veterinarian at least twice a year.

II.2. The oocytes used in the production of the embryos to be exported were collected on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease in the 30 days immediately prior to their collection and until their dispatch to the Union, in case of fresh embryos, or during the 30 days after collection, in case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.2.2.

II.3. From the time of collection of the oocytes until 30 days thereafter or, in the case of fresh embryos, until the day of dispatch, the embryos to be exported were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no occurrence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease.

II.4. The donors of oocytes used in the production of the embryos to be exported:

II.4.1. were located, during the 30 days immediately prior to collection of the oocytes, on premises within a 10-km radius of which, according to official findings, there was no occurrence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever, contagious bovine pleuropneumonia or lumpy skin disease;

II.4.2. showed no clinical signs of disease on the day of collection;

II.4.3. spent the six months immediately prior to collection within the territory of the exporting country in no more than two herds:

which, according to official findings, were free from tuberculosis during that time,

which, according to official findings, were free from brucellosis during that time,

which were free from enzootic bovine leukosis or in which no animal showed clinical signs of enzootic bovine leukosis during the previous three years,

in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months.

(1) either [II.4.4. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the oocytes.]

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COUNTRY

In vitro produced bovine embryos using semen from semen centres approved by the exporting country

II. Health information

II.a. Certificate reference No

II.b.

(1) or [II.4.4. were kept during a seasonally free period or protected from the vector for at least 60 days prior to, and during, the collection of the oocytes, and the embryos were produced without penetration of the zona pellucida, except if the donors underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results and the embryos were stored for at least 30 days.]

(1) or [II.4.4. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results, and the embryos were stored for at least 30 days.]

(1) or [II.4.4. underwent an agent identification test, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of collection or the day of slaughtering and giving negative results – the embryos having been produced, in the latter case, without penetration of the zona pellucida.]

II.5. The embryos to be exported were conceived by in vitro fertilisation using semen coming from semen collection or storage centres approved for the collection, processing and/or storage of semen by the competent authority of a third country or a part thereof listed in Annex I to Implementing Decision 2011/630/EU (4) or by the competent authority of a Member State.

Notes

In accordance with Article 3(a) of Directive 89/556/EEC, the in vitro produced bovine embryos using semen from semen centres approved by the exporting country, imported under the conditions laid down in this certificate are excluded from intra-Union trade.

Part I:

Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.

Box I.11: Place of origin shall correspond to the embryo production team from which the embryos are dispatch to the Union and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website:

http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

Box I.22: Number of packages shall correspond to the number of containers.

Box I.23: Identification of container and seal number shall be indicated.

Box I.26: Fill in according to whether it is a transit or an import certificate.

Box I.27: Fill in according to whether it is a transit or an import certificate.

Box I.28: Species: select amongst ‘Bos taurus’, ‘Bison bison’ or ‘Bubalus bubalis’ as appropriate.

Category: select ‘in vitro produced embryos’.

Dam identity shall correspond to the official identification of the animal.

Sire identity shall correspond to the official identification of the animal.

Date of freezing shall be indicated in the following format: dd.mm.yyyy

Approval number of the team: shall correspond to the embryo production team by which the embryos were produced, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

Part II:

(1) Delete as appropriate.

(2) Only third countries listed in Annex I to Decision 2006/168/EC.

(3) Only embryo production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

(4) Only third countries listed in Annex I to Implementing Decision 2011/630/EU.

The signature and the stamp must be in a different colour to that of the printing.

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COUNTRY

In vitro produced bovine embryos using semen from semen centres approved by the exporting country

II. Health information

II.a. Certificate reference No

II.b.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp:

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