Biosafety (Environmental Release) Regulations, 2011 (L.N. No. 98 of 2011).

These Regulations implement provisions of the Biosafety Act, 2009 in relation to introduction into the environment of a genetically modified organism (GMO) for which an approval has been granted in accordance with these Regulations and for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment (‘Environmental release’). Environmental release requires the approval of the National Biosafety Authority. Moreover, a person shall not place on the market a GMO without the written approval of the Authority. The Regulations also provide for, among other things, risk assessment, handling of information, public awareness and participation and registration of decisions of the Authority in the National Biosafety Clearing House.