PART IIAPPROVAL OF GERMINAL PRODUCT ESTABLISHMENTS, REGISTERS, RECORD-KEEPING AND TRACEABILITY

CHAPTER 3 Record-keeping and traceability

Section 1 Record keeping

Article 8Record-keeping obligations of operators of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals

1.

Operators of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals shall keep and maintain records containing at least the following information:

(a)

in respect of a semen collection centre:

  1. (i)

    the species, breed, date of birth and identification of each donor animal present at the semen collection centre;

  2. (ii)

    the dates of any movement of donor animals to and from the semen collection centre and, where those animals are accompanied by any document, the reference to those documents;

  3. (iii)

    the health status, the results of clinical and diagnostic tests and the laboratory techniques used, treatments and vaccinations carried out on the donor animals;

  4. (iv)

    the date of semen collection and, where relevant, the date and the place of processing of semen;

  5. (v)

    the identification of semen and details of its destination;

(b)

in respect of an embryo collection team, an embryo production team or an embryo collection and production team:

  1. (i)

    the species, breed, date of birth and identification of each donor animal from which oocytes or embryos were collected;

  2. (ii)

    the health status, the results of clinical and diagnostic tests and the laboratory techniques used, treatments and vaccinations carried out on donor animals of oocytes or embryos;

  3. (iii)

    the date and place of oocytes or embryos collection, examination, and processing;

  4. (iv)

    the identification of oocytes or embryos and details of their destination;

  5. (v)

    where micromanipulation is being performed on the embryos, the details of micromanipulation techniques used which involve penetration of the zona pellucida or, in case of equine embryos, the embryonic capsule;

  6. (vi)

    the origin of semen used for artificial insemination of donor animals or to fertilise oocytes for in vitro production of embryos;

(c)

in respect of a germinal product processing establishment or a germinal product storage centre:

  1. (i)

    the type of germinal products either processed and stored or stored at the approved germinal product establishment with reference to the species of the donor animal;

  2. (ii)

    the dates of movement of germinal products to and from the approved germinal product establishment with the reference to the documents which accompanied those germinal products;

  3. (iii)

    the documents, including an animal health certificate and a self-declaration document, confirming that the health status of the donor animals whose germinal products are either processed and stored or stored at the approved germinal product establishment complies with the requirements of this Regulation;

  4. (iv)

    the identification of germinal products that are either processed and stored or stored at the approved germinal product establishment.

2.

Where a germinal product establishment, referred to in paragraph 1(c), is approved by the competent authority for either processing and storage or storage of germinal products of more than one type or of more than one animal species, the operator shall keep and maintain records separately for each type of germinal product and germinal products of each animal species either processed and stored or stored.