SCHEDULE 4
PART 1

Matters to be taken into account in carrying out an assessment for the purposes of regulation 6
1
The following matters must 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 organism;
ii
the inserted genetic material (originating from the donor organism);
iii
the vector;
iv
the donor organism;
v
the resulting genetically modified organism;
b
the characteristics of the contained use;
c
the severity of the potentially harmful effects;
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
acting as a human disease vector or reservoir;
c
adverse effects to humans arising from change in behaviour or in physical nature;
d
adverse effects arising from the inability to treat human disease or offer effective prophylaxis.