The EFSA submission guidance provides guidelines for handling applications for authorisation of genetically modified (GM) plants for food and feed uses, import and processing, and/or cultivation (referred to hereafter as “GM plant applications”) in the European Union (EU), submitted under Regulation (EC) No 1829/2003. It consists of the following five chapters:
♦ Chapter 1 describes the EU procedure for handling GM plant applications;
♦ Chapter 2 provides detailed instructions on the structure of an application and the presentation of data in the desired format;
♦ Chapter 3 explains specific requirements for different parts of an application, in particular, Parts I, II and VIII;
♦ Chapter 4 explains requirements specific to applications concerning GM plants containing stacked events.
♦ Chapter 5 explains requirements specific for GM plants application for renewal of authorisation.
