S.L. 437.100 Art. 3Applicability.

(1) These rules shall apply to:

(a) the use of embryos of domestic animals of the bovine species as part of an efficient breeding policy which leads to better productivity and increased margins in this sector;

(b) the free movement of such embryos which encourage a rational development, taking into account the use of optimum production factors;

(c) the fulfilling of guarantees regarding animal health criteria with regard to intra-Community trade and imports into the Community of bovine animals from third countries, so that the risk of animal disease spreading is eliminated in the case of trade in embryos;

(d) the harmonization of national animal health provisions governing intra-Community trade in animals and animal products, and the necessity to create a harmonized system for intra-Community trade and imports into the Community of embryos of domestic animals of the bovine species;

(e) the obligations of the Member State of collection to ensure that:

(i) such embryos have been collected and processed by approved and supervised embryo collection teams;

(ii) they have been obtained from animals whose health status is such as to ensure that the risk of spread of animal disease is eliminated;

(iii) they have been collected, processed, stored and transported in accordance with the rules which preserve their health status and are accompanied during transport to the Member State of destination by an animal health certificate in order to ensure that such obligation has been fulfilled;

(f) vaccination against foot-and-mouth disease justifying the maintenance, for fresh embryos, of derogations, limited in time, authorizing additional protection by Member States against that disease;

(g) a list of third countries which should be drawn up, taking into account animal health criteria, from which embryos may be imported into the Community, provided that without prejudice to such a list, approval or authorisation of imports of embryos may also be suspended or withdrawn, if it is deemed appropriate to Member States that animal health criteria and standards have not been satisfied or fulfilled;

(h) on-the-spot checks which may be carried out in order to verify compliance with animal health standards and criteria;

(i) the prevention against transmission of certain contagious diseases, whereby import controls should be carried out when a consignment of embryos arrives and is placed on the market of the Community, and the measures to be taken by Member States after such controls have been defined, in case of internal transit.

(2) These rules shall not apply to embryos resulting from in vitro fertilization nor to embryos subjected to sexing, splitting (twinning), cloning or any manipulation which interferes with the integrity of the zona pellucida.

(3) The Director shall apply all such necessary administrative measures conforming to the requirements of the Food Chain and Animal Health according to the requirements of these rules, to ensure that there is no breach of these rules and also to reduce the risk for final consumers and any additional risk to animals and to the environment.

(4) These measures shall include the direct confiscation of the product, the suspension of the activities carried out by the authorised provider when these are creating a risk to final consumers and to the environment, and the forfeiture of any authorisation, licence or permit in addition to the application of any other administrative penalty in terms of article 61 of the Act.