Paragraph 5 Step 2: Long-term adverse effects and cumulative long-term adverse effects in the environmental risk assessment of applications to which Part 3 of these Regulations appliesF1
Long-term effects of a genetically modified organism are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a genetically modified organism or from an extensive use of a genetically modified organism in time and space.
The identification and evaluation of the potential long-term adverse effects of a genetically modified organism on human health and on the environment must take into account the following—
the long-term interactions of the genetically modified organism and the receiving environment,
the characteristics of the genetically modified organism which become important on a long- term basis, and
data obtained from repeated deliberate releases or placings on the market of the genetically modified organism over a long period.
The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introduction of this schedule must also take into account the genetically modified organisms deliberately released or placed on the market in the past.