A central element of Part A of the application form is the environmental risk assessment (ERA (environmental risk assessment)).
The risk assessment must be carried out separately for each GMO (Genetically Modified Organism) included in the application and, if applicable, also for combinations of GMOs.
The risk assessment should cover the effects of the GMOs that are due to interactions between the GMOs themselves and between the GMOs and the receiving environment (actual or potential) as specified in the introduction of the application. Such effects concern the safety of human health and the environment. Appendix 1 of the application form also lists specific aspects that must always be considered.
The steps required when performing an ERA are laid down in Annex II to EU Directive No. 2001/18/EC of the European Commission and the corresponding guidance notes (2002/623/EC). The risk assessment must take into account direct or indirect effects and immediate or delayed effects of the GMO on human health and the environment. An ERA consists of the following steps, which should be fully addressed and in the following order:
- List of likely adverse effects;
- Evaluation of the potential consequences of each adverse effect, if it occurs;
- Evaluation of the likelihood of the occurrence of each identified potential adverse effect;
- Based on the previous steps: an evaluation of the risks, and an estimation of the magnitude of such risks. The magnitude can be estimated by comparing it with the magnitude attributed to similar risks, for example where comparable effects are caused by non-GMOs in similar situations (baseline principle);
- If the conclusion of Step 4 is that the risk is not negligible, you should consider which risk management strategies (e.g. putting a plaster on an injection wound) can be applied to effectively reduce risks;
- Final conclusion of the risk assessment, stating the risk management strategies that will be employed, and a conclusion regarding the degree to which the risks are acceptable if the risk management strategies are applied.
Conclusions about possible environmental effects
Annex II of Directive 2001/18/EC lists under D1 a number of aspects that, whenever applicable, form the basis for the conclusions about the possible environmental effects of the proposed release of GMOs into the environment. The aspects that apply are mentioned in Part A, Appendix 1 of the application form and must be taken into account when drafting the conclusions of the risk assessment. A summary of the conclusions about possible environmental effects must be filled in for each of the points named in this appendix