Functional food regulation for edited crops

Introduction

Functional foods are food products that provide benefits beyond basic nutrition, such as supporting digestive health, improving nutritional intake or reducing certain health-related risks. They may contain naturally occurring or specially enhanced nutrients, including vitamins, minerals, antioxidants, dietary fibre and beneficial bioactive compounds. Genetic editing technologies, particularly CRISPR-Cas systems, can be used to modify crops to improve their nutritional composition and functional properties.

Examples include gene-edited crops with increased iron, zinc, protein or antioxidant content, reduced allergenic compounds, or improved fatty-acid composition. However, the development of such crops raises important legal questions concerning food safety, genetic modification, labelling, consumer protection and regulatory approval. In India, functional foods produced from edited crops must comply with applicable biotechnology, food safety and environmental laws.

Regulatory framework in India

The principal legislation governing food safety in India is the Food Safety and Standards Act, 2006. It establishes the Food Safety and Standards Authority of India (FSSAI), which regulates the manufacture, processing, distribution, sale and import of food products.

Section 16 provides for the functions of FSSAI, including establishing science-based food standards and regulating food safety. Section 22 specifically addresses genetically modified foods and other specialised food categories. Food products falling within the statutory definition of genetically modified or engineered food must satisfy the applicable regulatory requirements.

The Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 are also relevant. Where an edited crop or its ingredient falls within the category of non-specified food, prior approval may be required before its manufacture or sale.

However, not every gene-edited crop automatically follows an identical regulatory pathway. Its treatment depends on the nature of the genetic modification, the applicable government guidelines and the characteristics of the final food product.

Regulation of gene-edited crops

India regulates genetically engineered organisms primarily through the Environment (Protection) Act, 1986, and the Rules of 1989 concerning the manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered organisms or cells.

These Rules establish regulatory authorities and institutional mechanisms, including:

Institutional Biosafety Committee (IBSC): Supervises relevant research activities within institutions.

Review Committee on Genetic Manipulation (RCGM): Reviews specified research and safety-related activities.

Genetic Engineering Appraisal Committee (GEAC): Examines activities involving genetically engineered organisms within its statutory jurisdiction.

State Biotechnology Coordination Committee (SBCC): Performs state-level monitoring and coordination.

District Level Committee (DLC): Monitors relevant activities at the district level.

An important development is the Department of Biotechnology's Guidelines for Safety Assessment of Genome Edited Plants, 2022. These guidelines provide a differentiated framework for certain genome-edited plants.

Qualifying SDN-1 and SDN-2 genome-edited plants without foreign genetic material may be exempted from specified provisions of the 1989 Rules, subject to the prescribed verification and conditions. This exemption should not be interpreted as a general exemption from food safety, environmental, labelling or other applicable laws. It also does not automatically extend to gene-edited animals.

Food safety and nutritional assessment

Functional foods developed from edited crops must be assessed for their safety and nutritional characteristics. A crop developed to increase a particular nutrient may also undergo unintended changes in other components.

Therefore, regulatory assessment should consider:

Nutritional composition and the concentration of intended bioactive compounds.

Potential toxicity and allergenicity.

Changes in naturally occurring antinutritional substances.

Stability of the modified nutritional characteristics.

Possible effects on consumers with particular dietary sensitivities.

Appropriate conditions of cultivation, processing and storage.

The FSSAI's applicable standards and scientific assessment requirements are important in determining whether a functional food is suitable for human consumption. Claims about disease prevention, treatment or therapeutic effects must not be made merely because a crop has improved nutritional properties.

Labelling and consumer protection

Labelling is an essential part of regulating functional foods produced from edited crops. Consumers should receive accurate information about the product's identity, ingredients, nutritional composition and relevant regulatory status.

The Food Safety and Standards (Labelling and Display) Regulations, 2020, together with other applicable FSSAI requirements, govern food labelling and disclosure. The Legal Metrology Act, 2009, and the rules made under it may also apply to packaged products.

Manufacturers must avoid misleading statements such as claiming that a gene-edited food completely prevents a disease or provides guaranteed medical benefits. Nutritional and health claims must satisfy the relevant regulatory requirements.

Important judicial decisions

There is no widely established Indian Supreme Court judgment specifically dealing with functional foods developed through gene-edited crops. However, several decisions provide relevant principles.

1. S. Jagannath v. Union of India (1996)

The Supreme Court addressed environmental protection and the regulation of shrimp aquaculture in coastal areas. The judgment emphasised the precautionary approach and the need to protect ecological resources. Its principles are relevant when assessing environmental risks associated with the cultivation of edited crops.

2. A.P. Pollution Control Board v. Prof. M.V. Nayudu (1999)

The Supreme Court discussed scientific uncertainty, environmental decision-making and the precautionary principle. It recognised the importance of expert scientific assessment in matters involving potential environmental harm. These principles are relevant to the evaluation of risks associated with biotechnology and gene-edited agricultural products.

3. Vellore Citizens' Welfare Forum v. Union of India (1996)

The Supreme Court recognised the precautionary principle and the polluter-pays principle as important elements of Indian environmental law. The decision supports preventive regulatory measures where scientific uncertainty exists regarding potential environmental damage.

4. Indian Council for Enviro-Legal Action v. Union of India (1996)

The Supreme Court reinforced the responsibility of industries to address environmental harm caused by their activities. Its reasoning supports accountability in biotechnology-related industrial operations where environmental damage results from unsafe practices.

These decisions are relevant by analogy to environmental and scientific risk assessment; they do not directly establish approval requirements for gene-edited functional foods.

Regulatory challenges

The regulation of functional foods developed from edited crops faces several challenges. First, distinguishing qualifying genome-edited crops from conventional genetically modified organisms requires clear scientific and legal criteria. Second, regulators must evaluate whether nutritional improvements create unintended health risks. Third, labelling requirements must balance consumer transparency with scientifically justified information.

Another challenge is the difference between nutritional claims and medical claims. A food product containing enhanced antioxidants cannot automatically be advertised as a treatment for chronic diseases. Effective monitoring, laboratory testing and enforcement are therefore necessary.

Conclusion

Functional food regulation for edited crops requires coordination between biotechnology regulation, food safety standards, environmental protection and consumer rights. In India, the Food Safety and Standards Act, 2006, the 1989 Rules and the 2022 genome-editing guidelines form important parts of the regulatory framework. Judicial decisions concerning environmental protection and the precautionary principle provide additional guidance. A balanced regulatory system should encourage nutritional innovation while ensuring scientific assessment, transparent labelling, consumer safety and environmental responsibility.