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.