What Are Genetically Modified Foods?

According to the draft regulations, genetically modified or engineered foods include food products and ingredients that contain or are derived from genetically modified organisms (GMOs) developed through modern biotechnology. These regulations cover:

• Genetically modified organisms intended for direct use as food or for processing.
• Food and processed food containing genetically modified ingredients derived from GMOs, even if the final product does not contain living modified organisms.

Prior Approval from FSSAI

The draft regulations propose that no person may manufacture, store, distribute, sell or import food or food ingredients derived from GMOs without prior approval from the Food Authority.

The approval process would involve a safety assessment of the food or food ingredient.

Where genetically modified foods contain living modified organisms (LMOs), applicants would first need environmental safety approval from the Genetic Engineering Appraisal Committee (GEAC).

Products that do not contain LMOs in the final product could be submitted directly to FSSAI for approval. Once approval is granted, food business operators must obtain the required food licence under the applicable regulations.

Safety Assessment and Testing

The draft regulations outline requirements for assessing the safety of genetically modified foods.

Applicants may be required to submit information on:

• The genetic modification and its intended effects.
• The characteristics of the genetically modified organism.
• The presence of allergens, toxins or other potentially harmful substances.
• The nutritional composition of the food.
• Toxicological and allergenicity assessments.
• The regulatory status and history of safe use in the country of origin.

The draft also proposes the designation of specialised laboratories for GM food testing.

These laboratories would require appropriate facilities and equipment for detecting genetically modified materials using techniques such as:

• qRT-PCR for DNA or RNA detection.
• ELISA for protein detection.
• Western blotting and fluorescent microscopy for relevant analyses.

Labelling Requirements for GM Foods

The draft regulations propose that food products containing 1% or more of an individual genetically engineered ingredient must carry the following label:

“Contains GMO/Ingredients derived from GMO”

The proposed requirement applies to products meeting the specified threshold.

GM Foods and Infant Food

The draft regulations propose that genetically modified organisms, genetically engineered organisms and living modified organisms must not be used as ingredients in infant food.

Monitoring and Product Recall

Following approval, food business operators would be expected to take action if they have reason to believe that a genetically modified food poses a health risk. The draft provides for the suspension of manufacture, import, sale or distribution of such products and the initiation of a recall in accordance with the applicable food recall regulations.

What Happens After Approval?

The draft proposes that once a GMO, GEO or LMO with a unique identification code is approved by FSSAI, other food business operators would not need to obtain separate approval for the same approved organism or its use as an ingredient. However, the applicable regulatory requirements would still need to be followed.

Conclusion

The draft Food Safety and Standards (Genetically Modified or Engineered Foods) Regulations, 2021, outline a proposed framework for the approval, safety assessment, testing and labelling of genetically modified foods in India. The provisions aim to establish regulatory requirements for food businesses handling GM foods and ingredients.

Note: This article is based on the draft notification published by FSSAI on November 15, 2021. The provisions described above are proposals in the draft and should not be presented as current, enforceable requirements without verifying subsequent regulatory developments.

Read the official draft notification for the complete details here