Introduction:

Genetically Modified or Engineered Food means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified or engineered organisms obtained through modern biotechnology.

The Food Safety and Standards (Genetically Modified or Engineered Foods) Regulations, 2021 clearly states that No person shall manufacture, store, distribute, sell or import in the country any food or food ingredient, as the case may be, derived from Genetically Modified Organisms, except with the prior approval of the Food Authority.

Procedure for grant of prior approval:

1. In case a Genetically Modified or Engineered Food contains any Living Modified Organisms (LMOs), after taking prior approval from GEAC for Environmental safety, the application for the approval of the Food Authority may be submitted in Form-I along with the documents and fees as specified by the Food Authority from time to time.

2. In case a Genetically Modified or Engineered Food does not contain any LMOs, the application for the approval of the Food Authority may be submitted directly in Form-II along with the documents and fees as specified by the Food Authority from time to time.

3. The Food Authority shall scrutinize the application and information provided by the applicant.

4. The Food Authority may direct the applicant to submit additional supporting documents, data or clarifications, if required.

5. The Food Authority may either grant approval or reject the application on the basis of the safety assessment of the article of food or food ingredient of processing aid.

6. The food business operator shall, after grant of approval apply for license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.

7. A food business operator, who is aggrieved by the decision of the Food Authority, may file an appeal before the Chairperson.

8. The Food Authority may, for reasons to be recorded in writing, suspend or revoke any approval granted to any food business operator.

9. Post approval, if a food business operator has reason to believe that the Genetically Modified or Engineered Food poses any risk to health, he shall immediately suspend the manufacture, import, sale, or distribution of such article of food and take steps to recall the same in accordance with the provisions of the Food Safety and Standards (Food Recall) Regulations, 2017.

10. Food Safety Officers and Designated Officers shall immediately inform the Food Authority of any complaint received regarding safety of any product approved by the Food Authority under these regulations.

11. Once a Genetically Modified Organisms or Genetically Engineered Organisms or Living Modified Organisms having unique identification Code provided by Biosafety Clearing House, Organization for Economic Co-operation and Development etc, is approved by FSSAI, approval for the same will not be required for any other Food Business Operator. Approval will also not be required if it is used as an ingredient in any product.

12. Genetically Modified Organisms or Genetically Engineered Organisms or Living Modified Organisms shall not be used as an ingredient in any infant food.
All food products having individual Genetically Engineered (GE) ingredient 1% or more shall be labelled. The labelling shall be as: “Contains GMO/Ingredients derived from GMO”