Amendment of Schedule 16.

(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 11”.

(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 microorganisms 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.”.