SCHEDULE 1 E+WINFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET GENETICALLY MODIFIED HIGHER PLANTS

Part IV E+WINFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT

13.  A description of the trait or traits and characteristics of the genetically modified plant which have been introduced or modified.E+W

14.  The following information on the sequences actually inserted or deleted:E+W

(a)the size and structure of the insert and methods used for its characterisation, including information on any parts of the vector introduced into the genetically modified plant or any carrier or foreign DNA remaining in the genetically modified plant,

(b)the size and function of the deleted region or regions,

(c)the copy number of the insert, and

(d)the location or locations of the insert or inserts in the plant cells (whether it is integrated in the chromosome, chloroplasts, mitochondria, or maintained in a non-integrated form) and the methods for its determination.

15.  The following information on the expression of the insert—E+W

(a)information on the developmental expression of the insert during the lifecycle of the plant and methods used for its characterisation,

(b)the parts of the plant where the insert is expressed, such as roots, stem or pollen.

16.  Information on how the genetically modified plant differs from the parental or recipient plant in the following respects—E+W

(a)mode or modes and/or the rate of reproduction,

(b)dissemination,

(c)survivability.

17.  The genetic stability of the insert and phenotypic stability of the genetically modified plant.E+W

18.  Any change to the ability of the genetically modified plant to transfer genetic material to other organisms.E+W

19.  Information on any toxic, allergenic or other harmful effects on human health arising from the genetic modification.E+W

20.  Information on the safety of the genetically modified plant to animal health, particularly regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the genetically modified plant is intended to be used in animal feedstuffs.E+W

21.  The mechanism of interaction between the genetically modified plant and target organisms, if applicable.E+W

22.  The potential changes in the interactions of the genetically modified plant with non-target organisms resulting from the genetic modification.E+W

23.  The potential interactions with the abiotic environment.E+W

24.  A description of detection and identification techniques for the genetically modified plant.E+W

25.  Information about previous releases of the genetically modified plant, if applicable.E+W