Regulation establishing method of evaluation of risk caused by new substances to human health and to environment.

The Regulation of the Minister of Health, which is composed of 11 paragraphs and five Annexes, establishes that the risk evaluation shall include the following stages: identification of potential harmful changes to human health or to the environment; evaluation of dependencies between doses or level of risk and the level of intensification or frequency of changes or results; specification of emission, routes and speed of spreading of the new substance in the environment; estimated level of intensification or frequency of appearance of harmful changes in human health or in the environment as a result of the foreseen risk caused by the new substance.