Bovine Germinal Products

Regulation (EU) 2016/429 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law)

Commission Delegated Regulation (EU) 2020/686 - approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals

Commission Delegated Regulation (EU) 2020/692 - rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin

Commission Implementing Regulation (EU) 2021/403 - model animal health/official certificates for the entry into the Union of certain categories of terrestrial animals and germinal products thereof

Commission Implementing Regulation (EU) 2021/404 - lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products is permitted

Chapter 1 of Part V of the Animal Health Law sets out the requirements for entry into the union of germinal products of ungulates as follows;

(a) they must come from a listed third country or territory listed for the particular species and category of animals, or germinal products or products of animal origin concerned;

(b) they must come from establishments which are approved and listed;

(c) they must fulfil the necessary animal health requirements for entry into the Union;

(d) they must be accompanied by an animal health certificate and by declarations and other documents where required.

Title 2 of Part 1 of Commission Delegated Regulation (EU) 2020/692 sets out, inter alia, general animal health requirements for entry into the Union, and movement and handling after the entry of consignments of germinal products.

Title 1 of Part III sets out the specific animal health requirements for germinal products of ungulates.

Chapter 1 of Title I of Part III sets out the general animal health requirements for germinal products of ungulates regarding:

- The third country or territory of origin or zone thereof

- The residency period of donor animals (six months for bovines, at least 30 days in an establishment not under restriction)

- Identification of donor animals

- The germinal product establishments (must be approved)

- The germinal products themselves (marked and labelled correctly; fulfil animal health requirements).

Chapter 2 of Title I of Part III sets out specific animal health requirements for bovine germinal products, regarding the establishment of origin’s freedom from;

(i) infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis);

(ii) infection with Brucella abortus, B. melitensis and B. suis;

(iii) enzootic bovine leukosis;

(iv) infectious bovine rhinotracheitis/infectious pustular vulvovaginitis.

Certain derogations apply for donor animals or Germinal products coming from establishments not free from (iii) or (iv) above.

Approved collection centres and countries

- The semen must have been collected or produced, processed and stored in the appropriate establishment complying with the requirements of Commission Delegated Regulation (EU) 2020/686.

- The semen must originate from a Third Country listed in Annex IX of Commission Implementing Regulation (EU) 2021/404

Consignments of bovine germinal products from third countries must be accompanied by a health certificate, which conforms to the model as laid down in Commission Implementing Regulation (EU) 2021/403 which is signed by an official veterinarian or inspector of the veterinary authority in the country of origin.

Article 20 of this Regulation describes the model certificates available, the models of which are in Annex II of the same Regulation.

The animal health certificates to be used for the entry into the Union of certain types of germinal products of bovine animals shall correspond to one of the following models.

- The model certificate type depends on when the germinal products were collected and produced, and the type of establishment from which it was dispatched.

(a) BOV-SEM-A-ENTRY drawn up in accordance with the model set out in Chapter 39 of Annex II, for consignments of semen of bovine animals collected, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/692 after 20 April 2021, dispatched from the semen collection centre where the semen was collected;

(b) BOV-SEM-B-ENTRY drawn up in accordance with the model set out in Chapter 40 of Annex II, for consignments of stocks of semen of bovine animals collected, processed and stored after 31 December 2004 and before 20 April 2021 in accordance with Directive 88/407/EEC, as amended by Directive 2003/43/EC, dispatched after 20 April 2021 from the semen collection centre where the semen was collected;

(c) BOV-SEM-C-ENTRY drawn up in accordance with the model set out in Chapter 41 of Annex II, for consignments of stocks of semen of bovine animals collected, processed and stored before 1 January 2005 in accordance with Council Directive 88/407/EEC as amended by Council Directive 93/60/EEC, dispatched after 20 April 2021 from the semen collection centre where the semen was collected;

(d) BOV-OOCYTES-EMB-A-ENTRY drawn up in accordance with the model set out in Chapter 42 of Annex II, for consignments of oocytes and embryos of bovine animals collected or produced, processed and stored in accordance with Regulation (EU) 2016/429 and 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;

(e) BOV-in vivo-EMB-B-ENTRY drawn up in accordance with the model set out in Chapter 43 of Annex II, for consignments of stocks of in vivo derived embryos of bovine animals collected, processed and stored before 21 April 2021 in accordance with Council Directive 89/556/EEC, dispatched after 20 April 2021 by the embryo collection team by which the embryos were collected;

(f) BOV-in vitro-EMB-C-ENTRY drawn up in accordance with the model set out in Chapter 44 of Annex II, for consignments of stocks in vitro produced embryos of bovine animals produced, processed and stored before 21 April 2021 in accordance with Council Directive 89/556/EEC, conceived using semen complying with requirements of Council Directive 88/407/EEC, dispatched after 20 April 2021 by the embryo production team by which the embryos were produced;

(g) BOV-in vitro-EMB-D-ENTRY drawn up in accordance with the model set out in Chapter 45 of Annex II, for consignments of stocks of in vitro produced embryos of bovine animals produced, processed and stored before 21 April 2021 in accordance with Council Directive 89/556/EEC, conceived using semen coming from semen collection or storage centres approved by the competent authority of the exporting country, dispatched after 20 April 2021 by the embryo production team by which the embryos were produced;

(h) BOV-GP-PROCESSING-ENTRY drawn up in accordance with the model set out in Chapter 46 of Annex II, for consignments of germinal products listed below, dispatched after 20 April 2021 from the germinal product processing establishment:

- semen of bovine animals collected, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/692 after 20 April 2021;

- stocks of semen of bovine animals collected, processed and stored in accordance with Council Directive 88/407/EEC, as amended by Council Directive 2003/43/EC, after 31 December 2004 and before 21 April 2021;

- stocks of semen of bovine animals collected, processed and stored before 1 January 2005 in accordance with Council Directive 88/407/EEC as amended by Directive 93/60/EEC;

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

- stocks of in vivo derived embryos of bovine animals collected, processed and stored in accordance with Directive 89/556/EEC before 21 April 2021;

- stocks of in vitro produced embryos of bovine animals produced, processed and stored in accordance with Directive 89/556/EEC before 21 April 2021 and conceived using semen complying with requirements of Directive 88/407/EEC;

- stocks of in vitro produced embryos of bovine animals collected, processed and stored in accordance with Directive 89/556/EEC before 21 April 2021 and conceived using semen coming from semen collection or storage centres approved by the competent authority of the exporting country;

- (i) BOV-GP-STORAGE-ENTRY drawn up in accordance with the model set out in Chapter 47 of Annex II, for consignments of germinal products listed below, dispatched after 20 April 2021 from the germinal product storage centre:

- semen of bovine animals collected, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/692 after 20 April 2021;

- stocks of semen of bovine animals collected, processed and stored in accordance with Council Directive 88/407/EEC, as amended by Council Directive 2003/43/EC, after 31 December 2004 and before 21 April 2021;

- stocks of semen of bovine animals collected, processed and stored before 1 January 2005 in accordance with Council Directive 88/407/EEC as amended by Council Directive 93/60/EEC;

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

- stocks of in vivo derived embryos of bovine animals collected, processed and stored in accordance with Directive 89/556/EEC before 21 April 2021;

- stocks of in vitro produced embryos of bovine animals produced, processed and stored in accordance with Directive 89/556/EEC before 21 April 2021 and conceived using semen complying with requirements of Directive 88/407/EEC; stocks of in vitro produced embryos of bovine animals produced, processed and stored in accordance with Directive 89/556/EEC before 21 April 2021 and conceived using semen coming from semen collection or storage centres approved by the competent authority of the exporting country