This document provides guidance for the environmental risk
assessment(ERA) of genetically modified (GM) plants submitted
within the framework of Regulation (EC) No. 1829/2003 on GM food
and feed or under Directive 2001/18/EC on the deliberate release
into the environment of genetically modified organisms
(GMOs).
This document provides guidance for assessing potential effects of
GM plants on the environment and the rationales for the data
requirements for a comprehensive ERA of GM plants. The ERA should
be carried out on a case-by-case basis, following a step-by-step
assessment approach. This document describes the six steps for the
ERA of GM plants, as indicated in Directive 2001/18/EC, starting
with (1) problem formulation including hazard identification; (2)
hazard characterisation; (3) exposure characterisation; (4) risk
characterisation; (5) risk management strategies; and (6) an
overall risk evaluation.
The scientific Panel on Genetically Modified Organisms (of the
European Food Safety Authority (EFSA GMO Panel) considers seven
specific areas of concern to be addressed by applicants and risk
assessors during the ERA
(1) persistence and invasiveness of the GM plant , or its
compatible relatives, including plant-to-plant gene transfer
(2) plant-to-micro-organism gene transfer
(3) interaction of the GM plant with target organisms
(4) interaction of the GM plant with non target organisms,
including criteria for selection of appropriate species and
relevant functional groups for risk assessment
(5) impact of the specific cultivation, management and harvesting
techniques, including consideration of the production systems and
the receiving environment(s)
(6) effects on biogeochemical processes
(7) effects on human and animal health.
Each specific area of concern is considered in a structured and
systematic way following the above-mentioned steps (1 to 6). In
addition, the guidance document is supplemented with several
general cross-cutting considerations (e.g. choice of comparator,
receiving environment(s), general statistical principles, long-term
effects) that need to be considered in the ERA.
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