Regulation No. 377 of 2002 of Minister of Agriculture on the requirements for the preparation of a risk assessment for the performance of an animal test on a genetically modified animal and the data to be submitted in the risk assessment

The Regulation lays down the requirements for the preparation of a risk assessment for the performance of an animal experiment with a genetically modified animal and the data to be submitted in the risk assessment. It consists of ten sections: Scope of the Regulation (1); Potentially hazardous effects (2); Data to be provided in the risk analysis (3); Consideration of environmental protection and human health safety (4); Stages of risk analysis (5); Hazard identification (6); Assessment of the probability of realization of the threat (7); Assessment of the possible consequences of the realized threat (8); Risk assessment (9); and Obligation to select and develop correct and appropriate control techniques (10).