F1SCHEDULE 1PRINCIPLES FOR ENVIRONMENTAL RISK ASSESSMENT
PART CMETHODOLOGY
CHAPTER C.1GENERAL AND SPECIFIC CONSIDERATION FOR THE ENVIRONMENTAL RISK ASSESSMENT
Step 4: Stacked transformation events in applications to which Part 3 of these Regulations applies7
The following must apply to the environmental risk assessment of a genetically modified organism containing stacked transformation events in applications to which Part 3 of these Regulations applies—
a
the applicant must provide an environmental risk assessment for each single transformation event in the genetically modified organism or refer to already submitted applications (or equivalent notifications) for those single transformation events,
b
the applicant must provide an assessment of the following aspects—
i
the stability of the transformation events,
ii
the expression of the transformation events, and
iii
the potential additive, synergistic or antagonistic effects resulting from the combination of the transformation events, and
c
where the progeny of the genetically modified organism can contain various sub-combinations of the stacked transformation events, the applicant must provide a scientific rationale justifying that there is no need to provide experimental data for the concerned sub-combinations, independently of their origin, or, in the absence of such scientific rationale, must provide the relevant experimental data.
Sch. 1 inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), reg. 1(2)(b), sch. 1; 2020 c. 1, Sch. 5 para. 1(1)