For each of the areas of risk listed in section D.2 of Annex 2 to the Deliberate Release Directive the applicant must describe each pathway through which harm could occur in respect of the release of a genetically modified plant, taking hazard and exposure into account.
The applicant must provide— (a) the information described in paragraphs 21 to 27, and (b) the overall risk evaluation and conclusions described in paragraph 28, except where the applicant considers it is not relevant in view of the intended use of the genetically modified plant.
Information relating to the persistence and invasiveness including plant to plant gene transfer including— (a) an assessment of the potential for the genetically modified plant to become more persistent or invasive and the adverse environmental effects arising, (b) an assessment of the potential for the genetically modified plant to transmit transgenes to sexually compatible relatives and the adverse environmental effects arising, (c) conclusions on the adverse environmental effect of persistence and invasiveness of the genetically modified plant including the adverse environmental effect of plant to plant gene transfer.
Information relating to plant to micro-organism gene transfer including— (a) an assessment of the potential for transfer of newly inserted DNA from the genetically modified plant to micro-organisms and the adverse effects arising, (b) conclusions on the adverse effect of the transfer of newly inserted DNA from the genetically modified plant to micro-organisms on human and animal health and the environment.
Information relating to the interactions of the genetically modified plant, if relevant, with target organisms including— (a) an assessment of the potential for changes in the direct and indirect interactions between the genetically modified plant and target organisms and the adverse environmental effects arising, (b) an assessment of the potential for evolution of resistance of the target organism to the expressed protein based on the history of evolution of resistance to conventional pesticides or transgenic plants expressing similar traits, and any adverse environmental effects arising, (c) conclusions on adverse environmental effects of interactions of the genetically modified plant with target organisms.
(1) Information on the interactions of the genetically modified plant with non-target organisms including— (a) an assessment of the potential for direct and indirect interactions of the genetically modified plant with non-target organisms, including protected species, and the adverse effect arising, (b) conclusions on adverse environmental effects of interactions of the genetically modified plant with non-target organisms. (2) The assessment described in sub-paragraph (1) must take into account the potential adverse effect on relevant ecosystem services and on the species providing those services.
Information on the impacts of the specific cultivation, management and harvesting techniques including— (a) in respect of genetically modified plants for cultivation, an assessment of the changes in the specific cultivation, management and harvesting techniques used for the genetically modified plant and the adverse environmental effects arising, (b) conclusions on adverse environmental effects of the specific cultivation, management and harvesting techniques.
Information on biogeochemical processes including— (a) an assessment of the potential changes in the biogeochemical processes within the area in which the genetically modified plant is to be grown and in the wider environment, and the adverse effects arising, (b) conclusions on adverse effects on biogeochemical processes.
Information on the effects on human and animal health including— (a) an assessment of potential direct and indirect interactions between the genetically modified plant and persons working with or coming into contact with the genetically modified plant, including through pollen or dust from a processed genetically modified plant, and assessment of the adverse effects of those interactions on human health, (b) for a genetically modified plant not destined for human consumption, but where the recipient or parental organisms may be considered for human consumption, assessment of the likelihood of and possible adverse effects on human health due to accidental intake, (c) an assessment of the potential adverse effects on animal health due to accidental consumption of the genetically modified plant or of material from that plant by animals, (d) conclusions on the effects on human and animal health.
(1) The overall risk evaluation and conclusions must include a summary of each of the conclusions specified in paragraphs 21 to 27. (2) The summary referred to in sub-paragraph (1) must take into account the risk characterisation in accordance with steps 1 to 4 of the methodology described in Section C.3 of Annex 2 and the risk management strategies proposed in accordance with point 5 of Section C.3 of Annex 2 to the Deliberate Release Directive.
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