Paragraph 33

In relation to human health, animal health and plant health–

(a)

the toxic or allergenic effects of the organisms and/or their metabolic products;

(b)

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

(c)

the capacity of the organisms for colonisation;

(d)

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 and 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; and

(x)

availability of appropriate therapies; and

(e)

the other product hazards.