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FSSAI issues Draft Regulations for GMO Food Products


The Food Safety and Standards Authority of India (“FSSAI”) on November 15, 2021, issued Notification F.No.1/Standards/GM Food regulation/FSSAI/20181 which in turn notified the draft Food Safety and Standards (Genetically Modified or Engineered Foods) Regulations, 2021 (“Draft Regulations”). These Draft Regulations are governed by the Food Safety and Standards Act, 2006 (“Act”) and are applicable to Genetically Modified Organisms (“GMOs”), Genetically Engineered Organisms (“GEOs”), Living Modified Organisms (“LMOs”) which are intended to be used directly in the food and food processing industries. The FSSAI has currently invited comments and suggestions from all stakeholders in relation to the Draft Regulations.

Under the Draft Regulations, the expression “Genetically Modified or Engineered Food” refers to food and related ingredients which are composed of or contain genetically modified or engineered organisms obtained through biotechnology, or food and related ingredients produced from but not containing genetically modified or engineered organisms while the expressions “Genetically Modified Organisms”, “Genetically Engineered Organisms” and “Living Modified Organisms” refer to any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. It is observed that the implementation of Genetically Modified or Engineered Food biotechnology has been prevalent in the agriculture sector across many jurisdictions wherein such biotechnology is being used in the creation of modified crops which have: (i) improved yield; (ii) are significantly more resilient to diseases; and (iii) have increased tolerance vis-à-vis herbicides and pesticides. 

Key Regulatory Requirements

The Draft Regulations aim to control and regulate the production and consumption of GMOs, GEOs and LMOs throughout the country as they stipulate that, inter alia, no person shall import, sell, manufacture, store or distribute, any food or food ingredient derived from GMOs, except with the prior approval of the Food Authority.2 The Draft Regulations also outline the procedure for getting the relevant approvals and state the requisites for establishing the specified “food laboratories” for GMO foods testing. The Draft Regulations mandate that all food products containing an individual GEO ingredient of one percent (1%) or more shall be labelled with the stipulation that the food “Contains GMO/Ingredients derived from GMO”.


Currently, the only crop approved for cultivation is (bt) cotton and India has had an effective ban on other GM seeds for a considerable time. Bt brinjal, a genetically modified food crop is ready for large-scale field trials but its clearance is facing stiff resistance from farmers and environmentalists across the country. The publication of the Draft Regulations and the possibility of officially permitting use of GMO food products in India has raised numerous debates among public. Environmentalist strongly oppose use and consumption of GMO food products with adverse impact on health, food safety, soil and environmental at large whereas others rely on the perceived benefits and advantages of implementing this novel technology for better yield, productive and less food wastage. The finalisation and implementation of the Draft Regulations is subject to the responses and comments of the stakeholders and their assimilation in the Draft Regulations.

Endnotes: –

[1] https://fssai.gov.in/upload/uploadfiles/files/Draft_Notification_GM_Food_17_11_2021.pdf

[2]Food Authority” means the Food Safety and Standards Authority of India established under section 4 of the Act