FSSAI GM Foods

Overview of FSSAI GM Foods

Advanced genetic engineering techniques modify the genetic material of organisms to create Genetically Modified (GM) foods. The Food Safety and Standards Authority of India (FSSAI) oversees the regulation of GM foods in India, ensuring their safety and proper labelling through stringent safety assessments and labelling requirements. FSSAI continues to monitor scientific advancements and updates its regulations accordingly to address emerging challenges and ensure the safety of GM foods. The FSSAI is the primary regulatory body responsible for overseeing GMOs in India. The agency establishes rules and guidelines for assessing, approving, and labelling genetically modified foods to safeguard public health and promote environmental sustainability. These efforts are critical in managing GMOs' biodiversity impact and ecosystem effects. FSSAI ensures that GMOs comply with these regulations to protect consumer health and ensure transparency in the food supply chain. In India, GMO regulations include comprehensive safety assessments, labelling requirements, and monitoring of GM foods throughout their production, distribution, and sale. Compliance enforcement, traceability measures, and consumer education programmes support this regulatory framework, enhancing bioethics and consumer rights.

Introduction to GM Foods

Foods labelled as Genetically Modified (GM) are made from species whose genetic makeup (DNA) is altered with the help of modern technology by introducing a gene from another organism. Genetically modified foods have been created to increase output by introducing resistance to plant diseases or a higher tolerance to herbicides. The Food Safety and Standards Authority of India (FSSAI) set a 1% threshold for Genetically Modified Organisms (GMOs) in food crops imported into India. The Coalition for a GM-Free India complained to the government that this level is too high. It is an argument in favour of having no GMOs in food or certain other products. The FSSAI mandated a ‘non-GM-origin-cum-GM-free certificate’ issued by a competent authority for 24 food crops that the country imports. The authority established the GMO threshold for these crops' certification on February 8. The letter noted that as little as 0.01 percent of GMOs can be found in food by Indian laboratories. Therefore, the nation should strive to only accept shipments of goods that are certified GMO-free and contain no trace of genetically modified organisms (GMOs), particularly processed food.

FSSAI's Role in GM Food Regulation

The FSSAI plays a major role in managing genetically modified food in India. It is illegal to import, produce, consume, or sell genetically engineered food in India without prior permission from the Food Safety and Standards Authority of India (FSSAI). The only GMO that has been approved for import and growing in the nation thus far is cotton, a non-food crop. A separate organisational structure is being set up by the FSSAI for overseas genetically modified foods, named the GM Food Safety Assessment Unit, which is initially staffed with two scientific officers in charge of organising the receipt of applications for GM food safety, managing communications and correspondence with the applications, managing and tracking the applications, performing administrative reviews of the applications, confirming submitted documents, and serving as the secretariat for the GM Food and Export Committee on GM Food. Additionally, they are essential in overseeing stakeholder and public communications. This unit consists of a multidisciplinary group of scientists, including a molecular biologist, biochemist, immunologist, food allergy specialist, toxicologist, and nutritionist, who have been educated in GM food safety assessments units. It is located in Hyderabad at the National Institute of Nutrition.

FSSAI Safety Assessment for GM Foods

As per law, no individual shall manufacture, store, or distribute food ingredients produced from GMOs without the prior approval of the food authority. This also applies to the import and export of food articles based on GMOs. All the provisions of these regulations are outlined under the FSS Act of 2016. FSSAI requires business owners to apply for prior approval directly with the food authorities when it comes to GM food ingredients. Here is the detailed outline procedure for the same.

• Evaluation and Approval Process

  • The first step involves the food business operator, either a manufacturer or importer of the GM food, filing application as outlined by the food authority along with all the necessary documents and the fee associated with the application.
  • (2) In the event that the application pertains to a genetically modified organism (GMO) as specified in regulation 1's clause (a) subregulation (2), clearance. The national accountable authority, the Genetic Engineering Appraisal Committee (GEAC), will forward the environmental risk assessment to the Food Authority.
  • If the application is for a GMO referred to in clause a of Sub regulation 2 of Regulation 1, either it is used as a seed or other plant propagating material for cultivation, the food business operator should simultaneously submit an application to the GEC and the ministry of environment and forest and climate change for complaints along with the rules of 1989 governing the manufacture, use, import, export, and storage of hazardous microorganisms, genetically engineering organisms, or cells. The application has to be submitted in Form IIB to the application for environmental approval of transgenic plants of GEAC.
  • (4) The Food Authority must confirm that the applicant's details and supporting documentation match the information requested in order to prepare its opinion. It must also determine if the food is safe for human consumption.
  • (5) The Food Authority may provide the applicant a deadline by which to provide any further supporting documentation, information, or clarifications that may be needed
  • (6) The Food Authority will make an effort to make a decision within a maximum of six months of receiving a valid application.According to sub-regulation (4) of regulation 4, this deadline will be extended each time more information from the application is sought.
  • (7) The Food Authority may accept or reject the application in the way it specifies based on the food's safety examination.
  • (8) The food business operator must next apply for a license in compliance with the standards outlined in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 after receiving approval.
  • (9) The authorised holder and the parties involved must abide by any conditions or restrictions imposed in the approval after it has been issued in line with this Regulation. They specifically need to make sure that goods that aren't approved for sale as food aren't offered as such.
  • (10) The food business owner has 30 days from the date of the denial notice to file an appeal with the chairperson of the Food Authority.
  • (11) A food firm operator's approval may be suspended or revoked by the Food Authority for reasons that need to be recorded in writing.
  • (12) A food business owner must immediately stop the production, import, sale, or distribution of any genetically modified food if they have reason to believe that it poses a health risk. They must also take action to recall the food by notifying the Food Authority in compliance with the Food Safety and Standards (Food Recall Procedure) Regulations, 2017.
  • (13) A genetically modified organism (GMO) bearing the Organisation for Economic Cooperation and Development's (OECD) ‘Unique Identifier Nine-digit Code’ will not require further licenses once it has been approved by the Food Authority for use in food. However, if the GMO is going to be used as seed or any other type of plant propagation material, GEAC certification is required.
  • (14) GMOs as defined in sub-regulation (2) of regulation 1 clauses (a) and (b) may not be utilised as ingredients in foods for infants.

Regulations and Compliance for GM Foods in India

• FSSAI's GM Food Regulations

  The Food Safety and Standards Authority of India (FSSAI) has released draft regulations with respect to genetically modified food. These regulations propose compulsory prior approval from the regulator for the manufacturing, sale, and importation of food or ingredients derived from genetically modified organisms (GMOs). The proposed Food Safety and Standards (Genetically Modified Foods) Regulations, 2022 will include GMOs meant for food use, according to the FSSAI. Once enacted, these regulations will extend to food ingredients derived from GMOs, regardless of whether they contain modified DNA. This applies to any GMO-derived components, additives, or processing aids. Genetically modified organisms (GMOs) are described as living things with a unique genetic makeup that was created using contemporary biotechnology. The draft regulations stipulate that no individual shall engage in the manufacturing, packaging, storage, sale, marketing, distribution, or importation of any food or food ingredient derived from GMOs without prior approval from the food authority. Contains genetically modified organisms' must be labelled on all food products that come under the scope of these laws, including GMOs meant for food use and food additives containing changed DNA. If a product has one percent or more of a genetically modified ingredient on an individual basis, it must be labelled accordingly.

• Compliance Requirements for Food Businesses

  Within the food industry, rigorous standards govern production environments to ensure consumer safety. Local mandates and global standards dictate the quality control of food products and ingredients, aiming to elevate standards and streamline processes. Regulatory bodies respond to consumer demands, exemplified by public calls for reduced salt and sugar levels and the promotion of sustainable food production practices. Alignment with international standards aids food producers in meeting legal obligations. However, nations not adhering to ISO, FDA, or USDA guidelines may have devised their own methodologies. Implementing a food safety management system in line with ISO standards facilitates the identification and mitigation of food safety hazards throughout the production chain, benefiting stakeholders across industries, consumers, and regulatory bodies. Navigating food and beverage regulations can be intricate, presenting challenges in determining optimal compliance methods to ensure staff and consumer safety. Further insights on industry-wide regulations, segmented by food groups, countries, and regions, are provided to aid compliance efforts. As per the law all genetically modified foods must, without affecting the terms of these regulations, abide by the pertinent provisions of the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011, as applicable. Additionally, in accordance with the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, the genetically modified food must adhere to all applicable regulations.

Labelling and Consumer Information

• Labelling Standards for GM Foods

  • If any food product mentioned in clauses (a) and (b) of sub-regulation (2) of regulation 1 contains one percent or more of a genetically modified ingredient, it is required to be labelled with the words "Contains genetically modified organisms
  • The front of the package containing pre-packaged goods must include this label
  • The accidental or technically inevitable inclusion of genetically modified components is also subject to this labelling obligation
  • GM food products for which the changed DNA is undetectable, as mentioned in clause (c) of sub-regulation (2) of regulation 1, are exempt from this labelling requirement
  • Furthermore, all genetically modified foods must adhere to the labelling and packaging specifications outlined in the Food Safety and Standards (Packaging) Regulations, 2018 and Food.

Promoting Consumer Awareness

FSSAI initiates various steps to create major awareness among consumers when it comes to genetically modified ingredients. The labelling requirement for genetically modified foods requires the food business owner to outline the total percentage of genetically modified food ingredients used. This ensures transparency and consumer awareness. It is mandatory to clearly state the presence of GM ingredients and empower consumers to distinguish between regular and genetically modified products. Universal symbols are prescribed for quick identification, and strict penalties are introduced when it comes to non-complaints under FSSAI regulations. An expert panel on genetically modified organisms and foods are set by the FSSAI to conduct continuous research and create awareness among consumers.

Detection of GMOs in Food Supply

• Methods for GMO Detection

  • Polymerase Chain Reaction (PCR): PCR is a widely used technique that amplifies specific DNA sequences from the sample, allowing for the detection of GMO-specific sequences.
  • Real-Time PCR: This method provides quantitative data on the amount of GMO present in a sample by measuring the fluorescence emitted during PCR amplification in real-time.
  • DNA Microarrays: Microarrays allow for the simultaneous detection of multiple GMO targets in a single assay by immobilising DNA probes on a solid surface and hybridising them with target DNA from the sample.
  • Next-Generation Sequencing (NGS): NGS enables the comprehensive analysis of DNA sequences in a sample, making it possible to detect and characterise GMOs with high accuracy and resolution.
  • Enzyme-Linked Immunosorbent Assay (ELISA): ELISA detects GMO proteins by utilising antibodies that specifically bind to GMO proteins in the sample, producing a measurable signal.
  • Lateral Flow Devices (LFDs): LFDs provide rapid and on-site detection of GMOs by utilising antibodies or DNA probes that capture GMO-specific molecules, resulting in a visible signal.
  • Mass Spectrometry: Mass spectrometry can be used to detect and quantify GMO proteins in food products by analysing the mass-to-charge ratios of peptides generated from enzymatic digestion of the proteins.
  • Bioinformatics Tools: Computational methods play a crucial role in GMO detection by analysing DNA or protein sequences to identify GMO-specific signatures or by comparing experimental data with reference databases.

• Monitoring and Surveillance Systems

  FSSAI establishes and enforces regulations governing the production, import, sale, and labelling of GM foods in India, ensuring compliance with relevant laws and standards. FSSAI conducts risk assessments to evaluate the safety of GM foods, considering factors such as potential allergenicity, toxicity, and environmental impact. FSSAI requires food businesses involved in the production, import, or sale of GM foods to obtain appropriate licenses or registrations, enabling better oversight and control.