1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and temporary negative impact on the health of the person concerned.

The nature and scale of the activity need to be considered in order to estimate the possibility of exposure of humans and the environment and will also affect the choice of appropriate risk management procedures.

Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated withliving modified organisms,

The assessment requires that the risk of these potentially harmful effects are considered for each activity and allocated to a class as defined in Article 5, taking into account both the nature and scale of operations, to determine the final containment facilities required.

Whereas the precise nature and scale of risks associated with genetically modified micro-organisms are not yet fully known and the risk involved must be assessed case by case;

Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms,