Directive on Risk Assessment Parameters for Modified Organisms No. 05/ 2018”

This Directive shall be applicable for any transaction of modified organism that has yet not been given an advance informed agreement or special permit by the ministry. Moreover the Directive establishes that any person who engages in any transaction of modified organisms shall carry out a risk assessment to evaluate possible harm to human or animal health and the environment prior to any activity; the extent of data or information required may vary depending on whether the transaction is for deliberate release or contained use; upon decision making, the Ministry shall take into account inclusion of socio-economic considerations. Part 2 of the Directive provides requirements for the information that shall be presented in relation to: characteristics of donor and recipient or parental organisms; characteristics of the vector, promoter, terminator and marker genes; characteristics of modified organism; information on modified organisms with respect to safety considerations for human and animal health; information on modified organisms with respect to environmental considerations; essential information related to anticipated socio-economic impacts such as on sustainable agriculture, employment, market opportunities and, in general, conserving and/or enhancing means of livelihood of the communities likely to be affected.