CHAPTER 1 — Approval of germinal product establishments
Requirements for the approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals
Operators of the following germinal product establishments for bovine, porcine, ovine, caprine and equine animals shall apply in accordance with Article 94(1)(b) of Regulation (EU) 2016/429 to the competent authority for approval for the purpose of moving consignments of germinal products of those animals to other Member States:
(a)
the establishment where semen of bovine, porcine, ovine, caprine or equine animals is collected, processed and stored for approval as a semen collection centre;
(b)
the group of professionals or the structure supervised by a team veterinarian competent to perform the collection, processing and storage of embryos of bovine, porcine, ovine, caprine or equine animals for approval as a embryo collection team;
(c)
the group of professionals or the structure supervised by a team veterinarian competent to perform the collection, processing and storage of oocytes and production, processing and storage of embryos of bovine, porcine, ovine, caprine or equine animals for approval as an embryo production team;
(d)
the establishment where fresh, chilled or frozen semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals are processed and stored for approval as a germinal product processing establishment;
(e)
the establishment where fresh, chilled or frozen semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals are stored for approval as a germinal product storage centre.
Approval by the competent authority of germinal product establishments for bovine, porcine, ovine, caprine and equine animals
1. The competent authority shall only grant approval of a germinal product establishment for bovine, porcine, ovine, caprine or equine animals as referred to in Article 97 of Regulation (EU) 2016/429 after it has ensured that it complies with the following requirements:
(a)
the operator has appointed:
(i)
a centre veterinarian responsible for the activities set out in:
—
point 1 of Part 1 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (a) of Article 3 as a semen collection centre,
—
point 1 of Part 4 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (d) of Article 3 as a germinal product processing establishment,
—
point 1 of Part 5 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (e) of Article 3 as a germinal product storage centre; or
(ii)
a team veterinarian responsible for the activities set out in:
—
point 1 of Part 2 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (b) of Article 3 as a embryo collection team,
—
point 1 of Part 3 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (c) of Article 3 as a embryo production team;
(b)
the facilities, equipment and operational procedures for the activity in question comply with the requirements set out in:
(i)
point 2 of Part 1 of Annex I, in respect of the collection, processing, storage and transport of semen of bovine, porcine, ovine, caprine or equine animals;
(ii)
point 2 of Part 2 of Annex I, in respect of the collection, processing, storage and transport of embryos of bovine, porcine, ovine, caprine or equine animals;
(iii)
point 2 of Part 3 of Annex I, in respect of the collection of oocytes and of the production, processing, storage and transport of embryos of bovine, porcine, ovine, caprine or equine animals, including the processing and storage of semen and oocytes used for the embryo production;
(iv)
point 2 of Part 4 of Annex I, in respect of the processing, storage and transport of fresh, chilled or frozen semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals;
(v)
point 2 of Part 5 of Annex I, in respect of the storage and transport of fresh, chilled or frozen semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals.
2. When granting approval of a germinal product establishment for bovine, porcine, ovine, caprine and equine animals, as referred to in Articles 97 and 99 of Regulation (EU) 2016/429, the competent authority shall assign it with a unique approval number, which shall include the ISO 3166-1 alpha-2 code of the country in which the approval is granted.
Special rules for the cessation of activities of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals
1. Where the operator of an approved germinal product establishment for bovine, porcine, ovine, caprine and equine animals ceases its activity, that operator shall ensure that prior to the withdrawal date of the approval all consignments of semen, oocytes or embryos collected or produced and stored in that germinal product establishment have been moved:
(a)
to a germinal product storage centre for further storage; or
(b)
for reproduction purposes to an establishment where bovine, porcine, ovine, caprine or equine animals are kept; or
(c)
for safe disposal or use as animal by-products in accordance with Article 13 of Regulation (EC) No 1069/2009.
2. Where consignments of semen, oocytes or embryos are not moved from the approved germinal product establishment prior the withdrawal date of the approval as referred to in paragraph 1, such consignments shall not be moved to another Member State.
CHAPTER 2 — Registers to be kept by the competent authority of registered and approved germinal product establishments
Register to be kept by the competent authority of registered germinal product establishments
1. The competent authority shall draw up and keep up-to-date a register of registered germinal product establishments.
2. The competent authority shall include at least the following information in the register referred to in paragraph 1, for each registered germinal product establishment:
(a)
the name, contact details and, where available, the Uniform Resource Locator (URL) of the website of the registered germinal product establishment;
(b)
the address of the registered germinal product establishment;
(c)
the type of germinal products and animal species for which it was registered;
(d)
the unique registration number assigned by the competent authority and the date of the registration;
(e)
if activities of the registered germinal product establishment have ceased, the date of cessation of those activities.
Register to be kept by the competent authority of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals
1. The competent authority shall draw up and keep up to date a register of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals.
2. The competent authority shall include at least the following information in the register referred to in paragraph 1 for each approved germinal product establishment:
(a)
the name, contact details and, where available, the URL of the website of the germinal product establishment;
(b)
the address of the germinal product establishment;
(c)
the name of the centre veterinarian or the team veterinarian;
(d)
the type of germinal products, the type of the germinal product establishment and animal species for which the approval has been granted;
(e)
the unique approval number assigned by the competent authority and the date of the approval.
3. Where, based on requirements provided for in Article 4, a germinal product processing establishment or a germinal product storage centre is approved by the competent authority for the storage and, in respect of the germinal product processing establishment, the processing, of germinal products of more than one type or of more than one animal species, the competent authority shall include information on the type of the germinal products and on the animal species thereof stored and, if applicable, processed at the approved germinal product establishment in its register of approved germinal product establishments.
4. Where the competent authority has suspended or withdrawn the approval of an approved germinal product establishment in accordance with Article 100(2) of Regulation (EU) 2016/429, it shall, without undue delay:
(a)
indicate that suspension or withdrawal in its register of approved germinal product establishments;
(b)
specify in the case of the suspension of the approval, the commencement and end date, and in the case of withdrawal, the withdrawal date of the approval.
5. Where an approved germinal product establishment has ceased its activity as referred to in Article 5, the competent authority shall, without undue delay, indicate the date of cessation of those activities in its register of approved germinal product establishments.
6. The competent authority shall make the register referred to in paragraph 1 available to the public on its website, where germinal products are to be moved between Member States and notify the URL of that website to the Commission.
Where the URL of the website of a competent authority has been changed it shall notify, without undue delay, the new URL of that website to the Commission.
CHAPTER 3 — Record-keeping and traceability
Section 1 — Record keeping
Record-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:
(i)
the species, breed, date of birth and identification of each donor animal present at the semen collection centre;
(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;
(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;
(iv)
the date of semen collection and, where relevant, the date and the place of processing of semen;
(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:
(i)
the species, breed, date of birth and identification of each donor animal from which oocytes or embryos were collected;
(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;
(iii)
the date and place of oocytes or embryos collection, examination, and processing;
(iv)
the identification of oocytes or embryos and details of their destination;
(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;
(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:
(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;
(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;
(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;
(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.
Record-keeping obligations of operators of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals that cease their activity
1. Where an approved germinal product establishment for bovine, porcine, ovine, caprine and equine animals ceases its activity as referred to in Article 5, the operator of that establishment shall only move consignments of stored germinal products to a germinal product storage centre if such consignments are accompanied by originals or copies of the records required in accordance with Article 8(1).
2. The operator of the germinal product storage centre receiving the consignment of germinal products from the establishment that has ceased its activity as referred to in paragraph 1 shall record the entry and details of the germinal products based on the accompanying records required in accordance with Article 8(1)(c).
Traceability requirements for germinal products of bovine, porcine, ovine, caprine and equine animals
1. Operators collecting, producing, processing or storing germinal products of bovine, porcine, ovine, caprine or equine animals shall mark each straw or other package in which semen, oocytes or embryos, whether or not separated into individual doses, are placed, stored and transported, in such a way that the following information can be readily established:
(a)
the date of collection or production of those germinal products;
(b)
the species and identification of the donor animal(s);
(c)
the unique approval number of the germinal product establishment of collection or production, processing and storage of those germinal products;
(d)
any other relevant information.
2. In case of sex-sorting of semen at a germinal product processing establishment, the operator of the semen collection centre shall supplement the information referred to in paragraph 1 with information which permits the identification of the unique approval number of the germinal product processing establishment where that semen was sex-sorted.
3. Where a single straw or another package contains semen of bovine, porcine, ovine or caprine animals collected from more than one donor animal, the operator shall ensure that the information referred to in paragraph 1 permits the identification of all donor animals that have contributed to the dose of semen used for insemination.
4. By way of derogation from paragraph 1, where the semen of ovine or caprine animals is
(a)
frozen in pellets, the operator may mark the goblet containing the semen pellets of a single donor instead of marking each individual pellet in that goblet;
(b)
fresh or chilled semen, the operator may mark the goblet containing the semen tubes or straws of a single donor instead of marking each individual tube or straw in that goblet.
5. By way of derogation from paragraph 1(c), the operator shall ensure that the marking of each straw or other package in which semen, oocytes or embryos are placed, stored and transported, is carried out in such a way that it permits the identification of:
(a)
in the case of semen of ovine and caprine animals which has been collected at the establishment where the donor animals are kept as referred to in Article 13, the unique registration number of that establishment; or
(b)
in the case of germinal products of bovine, porcine, ovine, caprine or equine animals which have been collected or produced at a confined establishment referred to in Article 14, the unique approval number of that confined establishment.
Traceability requirements for germinal products of dogs and cats, terrestrial animals other than bovine, porcine, ovine, caprine and equine animals kept at confined establishments, and animals of the families Camelidae and Cervidae
1. Operators collecting, producing, processing or storing germinal products of dogs or cats, of terrestrial animals other than bovine, porcine, ovine, caprine or equine animals kept at confined establishments or of animals of the family Camelidae or Cervidae shall mark each straw or other package in which semen, oocytes or embryos, whether or not separated into individual doses, are placed, stored and transported in such a way that the following information can be readily established:
(a)
the date of collection or production of those germinal products;
(b)
the species, where necessary subspecies, and identification of the donor animal(s);
(c)
one of the following:
(i)
the address of the establishment of collection or production, processing and storage of those germinal products;
(ii)
where the establishment of collection or production, processing and storage of those germinal products was assigned with a unique registration number, the unique registration number which shall include the ISO 3166-1 alpha-2 code of the country in which the establishment is registered;
(iii)
where the establishment of collection or production, processing and storage of those germinal products is a confined establishment, the unique approval number which shall include the ISO 3166-1 alpha-2 code of the country in which the approval is granted;
(d)
any other information.
2. In case of sex-sorting of semen at an establishment other than the establishment of its collection or production, the operator of the establishment of collection or production of that semen shall supplement the information referred to in paragraph 1 with information which permits the identification of the establishment where that semen was sex-sorted.
3. By way of derogation from paragraph 1, where the semen of the animals referred to in paragraph 1 is frozen in pellets, the operator may mark the goblet containing semen pellets of a single donor instead of marking each individual pellet in that goblet.
4. Where a single straw or another package contains semen collected from more than one donor animal, the operator shall ensure that the information, referred to in paragraph 1, includes the identification of all donor animals.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
