Paragraph 8 F1
The environmental risk assessment must take into account the relevant technical and scientific details regarding characteristics of—
the recipient or parental organism(s),
the genetic modification(s), be it insertion or deletion of genetic material, and relevant information on the vector and the donor,
the genetically modified organism,
the intended release or use including its scale,
the potential receiving environment(s) into which the genetically modified organism will be released and into which the transgene may spread, and
the interaction(s) between these characteristics.
Relevant information from previous releases of the same or similar genetically modified organisms and organisms with similar traits and their biotic and abiotic interaction with similar receiving environments, including information resulting from the monitoring of such organisms, must be considered in the environmental risk assessment, subject to regulations 11(2) and 16(3).