In accordance with the laws, regulations, and policies of India and the Cartagena Protocol on Biosafety, the objective of “Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants, 2016” (the Guidelines) is to ensure the safe development and use of plants resulting from modern biotechnology through the assessment of potentially adverse effects that these plants may have on humans, the environment and biological diversity. These Guidelines describe a comprehensive, transparent and science-based framework by which regulators can identify potential harms that might be caused by genetically engineered (GE) plants, collect relevant scientific data pertaining to the nature and severity of any harms, and consistently characterize the level of risk posed by the use of genetically engineered plants. This framework uses a conventional approach to risk assessment similar to ones used in many other areas of risk assessment and it incorporates a case-by-case approach that takes into account a variety of sources of information. The guidance provided herein has been developed for planning and conducting an environmental risk assessment in support of the release of a GE plant in India for the purpose of cultivation. The topics of risk assessments performed prior to the testing of regulated GE plants in confined field trials and safety assessments of food and feed produced from GE plants are covered in separate guidance. This guidance provides a practical elaboration of the risk assessment framework included in the Indian regulations and in Annex III of the Cartagena Protocol on Biosafety, to which India is a Party and it is also consistent with the consensus documents published by the Organization for Economic Cooperation and Development’s (OECD’s) Working Group on Harmonization of Regulatory Oversight in Biotechnology.