The Food Safety and Standards (Genetically Modified Foods) (Draft) Regulations, 2022.

The Food Safety and Standards Authority of India on 18th November 2022, notified the Food Safety and Standards (Genetically Modified Foods) (Draft) Regulations, 2022 and has invited objection/suggestion from the public which shall be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, FDA Bhawan, Kotla Road, New Delhi – 110002 or sent on email at regulation@fssai.gov.in within a period of 60days.

This regulation shall apply to Genetically Modified Organisms (GMOs) intended for food use, Food ingredients produced from GMOs that contain modified DNA and Food ingredients produced from GMOs that do not contain modified DNA. It includes ingredients/additives/processing aids derived from GMOs.

However this regulation shall not apply to genome edited crops of SDN1 and SDN2 category.

As per this regulation, No person shall manufacture, pack, store, sell, market or otherwise distribute or import any food or food ingredient produced from GMOs, except with the prior approval of the Food Authority.

The food business operator (manufacturer/importer) of a GM-food shall submit an application as per the format prescribed by the Food Authority along with necessary documents and fee to the Food Authority. The Food Authority may either grant approval or reject the application as per the format prescribed by the Food Authority on the basis of the safety assessment of the food.

The food business operator shall, after grant of approval obtain a license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. After an approval has been issued in accordance with this Regulation, the authorised holder and the parties concerned shall comply with any conditions or restrictions which have been imposed in the approval and shall in particular make sure that products not covered by the approval are not placed on the market as food.

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