SCHEDULE 3

PART IMATTERS TO BE TAKEN INTO ACCOUNT IN CARRYING OUT ANASSESSMENT FOR THE PURPOSES OF REGULATION 6

1

The following matters shall be taken into account in carrying out an assessment for the purposes of regulation 6—

a

any potentially harmful effects, in particular those associated with—

i

the recipient micro-organism,

ii

the inserted genetic material (originating from the donor organism),

iii

the vector,

iv

the donor micro-organism (where that donor micro-organism is used during the activity involving genetic modification), and

v

the resulting genetically modified micro-organism;

b

the characteristics of the activity;

c

the severity of the potentially harmful effects; and

d

the likelihood of the potentially harmful effects being realised.

2

In paragraph 1, “potentially harmful effects” includes—

a

disease to humans including allergenic or toxic effects;

b

disease to animals or plants;

c

adverse effects resulting from the inability to treat disease or offer an effective prophylaxis;

d

adverse effects resulting from establishment or dissemination of the genetically modified micro-organisms in the environment;

e

adverse effects resulting from the natural transfer of genetic material to or from other organisms;

f

adverse effects resulting from the likely interaction of the genetically modified micro-organism with other organisms at the premises where the activity involving genetic modification is to be conducted.