Directive to Determine the Content of an Application for Undertaking Transaction Involving Deliberate Release of Modified Organisms No. 08 /2018.

This Directive is applicable to an application submitted to engage in transaction for introduction into the environment of any modified organism for which no specific containment measures are used to limit their contact with the environment. The Directive clarifies: general information that the application for undertaking transactions involving deliberate release of modified organisms shall contain; information of donor, recipient and the modified organism (Part 2) and information relating to the receiving environment and interaction between the modified organism and the receiving environment (Part 3; such as survival, multiplication, dispersal and trait expression; potential environmental impacts), and additional information required (where the transaction relates to the placing of modified organism as food on the market; or placing of the modified organism as feed; or package containing the modified organism).