either [II.2.12.1. approved in accordance with Article 11(2) of Directive 92/65/EEC and located in a Member State of the European Union; and the semen complies with the requirements of Directive 92/65/EEC.]
soit [II.2.12.1. agréé(e) conformément à l’article 11, point 2, de la directive 92/65/CEE et situé(e) dans un État membre de l’Union, le sperme étant conforme aux exigences de la directive 92/65/CEE.]