Any adverse socio-economic effects must also be considered. No authorization may be given unless there is firm evidence that there are no risks posed to the environment and human and animal health. This is a very stringent requirement. As a fall back position the decision can be based on the precautionary principle as set out in paragraph 4 above. When approval is given, it may be with or without any conditions.
Any approval given is on a step by step basis.
That is, it progresses from activity that is contained, then to trials that are in the open before full fledged release is authorized. At each stage, the risks are monitored. Approval may be revoked Any approval given shall be revoked if new evidence, or a review of existing information, shows potential risks based on the precautionary principle. Alternatively, fresh or additional conditions may be imposed. There is an obligation on the applicant to provide information of any possible risks that become known to him at any time.