Paragraph 3 Health considerations

The following matters shall be investigated and assessed in relation to an organism in relation to which a risk assessment under regulation 7 is carried out—

(a)

toxic or allergenic effects of non-viable organisms and/or their metabolic products;

(b)

product hazards;

(c)

comparison of the modified micro-organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;

(d)

capacity for colonization;

(e)

if the organism is pathogenic to humans who are immunocompetent—

(i)

diseases caused and mechanism of pathogenicity including invasiveness and virulence,

(ii)

communicability,

(iii)

infective dose,

(iv)

host range, possibility of alteration,

(v)

possibility of survival outside of human host,

(vi)

presence of vectors or means of dissemination,

(vii)

biological stability,

(viii)

antibiotic-resistance patterns,

(ix)

allergenicity,

(x)

availability of appropriate therapies.