Amendment of Schedule 1I16

1

Schedule 1 (information to be included in applications for consent to release or market genetically modified higher plants) is amended as follows.

2

In the title, for the words following “consent to release” substitute “ genetically modified higher plants for non-marketing purposes ”.

3

For the shoulder note substitute “ Regulation 12 ”.

4

In paragraph 7, at the end insert “ in Europe ”.

5

In paragraph 8, for “in the United Kingdom” substitute “ in Europe ”.

6

For paragraph 15 substitute “ Information on parts of the plant where the insert is expressed ”.

7

After paragraph 15 insert—

15A

The genetic stability of the insert and phenotypic stability of the genetically modified plant.

15B

Conclusions on the molecular characterisation of the genetically modified plant.

8

Omit paragraphs 16 and 17.

9

For paragraphs 18 to 23 substitute—

PART 4AInformation on specific areas of risk

18

Information on—

a

any change to the persistence or invasiveness of the genetically modified plant and its ability to transfer genetic material to sexually compatible relatives and the adverse environmental effects arising,

b

any change in the ability of the genetically modified plant to transfer genetic material to micro-organisms and the adverse environmental effects arising,

c

the mechanism of interaction between the genetically modified plant and target organisms, if applicable, and the adverse environmental effects arising,

d

potential changes in the interactions of the genetically modified plant with non-target organisms resulting from the genetic modification and the adverse environmental effects arising,

e

potential changes in agricultural practices and management of the genetically modified plant resulting from the genetic modification, if applicable, and the adverse environmental effects arising,

f

potential interactions with the abiotic environment and the adverse environmental effects arising,

g

any toxic, allergenic or other harmful effects on human health arising from the genetic modification,

h

conclusions on the specific areas of risk.

10

Under the heading to Part 5 omit “(Applications for consent to release only)”.

11

Under the heading to Part 6 omit “(Applications for consent to release only)”.

12

Under the heading to Part 7 omit “(Applications for consent to release only)”.

13

For paragraph 35 substitute—

35

1

A description of any precautions to maintain spatial and, as the case may be, temporal separation of the genetically modified plant from sexually compatible plant species.

2

In sub-paragraph (1) “plant species” means—

a

wild and weedy relatives, or

b

crops.