Current regulatory framework and regulatory approvals

Establishing clear regulatory frameworks for smart protein products sets them up for market success.

Regulatory leadership by the Food Safety and Standards Authority of India

Food regulations for licensing, labelling, and approvals of novel foods affect how smart protein products reach consumers in India. The Food Safety and Standards Authority of India (FSSAI), the apex food regulatory body in India, is at the forefront of driving forward innovative food categories such as smart proteins while keeping consumer safety in mind. It sets science-based standards to regulate the manufacture, storage, distribution, sale, and import of food products and ingredients to ensure the availability of safe and nutritious food to consumers.

The Food Safety and Standards Act, 2006, along with the rules and regulations formulated under it, governs the path to market of all food products, including smart proteins (refer to the State of the Industry Report to understand the relevant regulatory framework for smart protein products in India). Apart from the FSSAI’s central authority, it also has four regional offices that grant food licenses to food business operators, including smart protein companies.

Current regulatory framework and approvals in India

FSSAI’s regulatory leadership in supporting companies utilising innovative technologies to provide sustainable solutions to fix the food systems would set the pace for India to emerge as a key market for smart protein products.

Status of regulatory approvals in India

Plant-based

Plant-based protein alternatives to meat, eggs and dairy have been in the market for a while, and continue to diversify and scale on key parameters through innovative inputs and technologies. These products utilise ingredients that have been standardised by the FSSAI in the Food Safety and Standards (Food Product Standards and Food Additives) Regulation, 2011, but are new applications/formats of those ingredients that have not been defined by standards and hence are mostly classified as proprietary products. There are over 73 plant-based meat, eggs, and dairy companies with over 377 products across 41 formats in the market.

Fermentation and microbial proteins

In 2022, under its Approval for Non-Specified Food and Food Ingredients Regulations (“NSF Regulation”, the FSSAI granted prior approval (pre-market approval) to two smart protein products – ACME’s mycoprotein derived from Fusarium venenatum and Perfect Day’s non-animal derived whey protein that utilises precision fermentation. In 2023, the Food Safety and Standards Authority of India (FSSAI) granted prior approval to Reliance’s phototrophic algal biomass-derived protein powder NSF Regulations. In 2024, Nature’s Fynd received regulatory approval from the FSSAI for its biomass fermentation-derived Fy Protein (Nutritional Fungal Protein derived from Fusarium str. flavolapis). A few more fermentation-derived companies are in the process of applying for regulatory approvals.

Cultivated meat

While the FSSAI has not received any application for cultivated meat product approval yet, it is considering the regulatory requirements for CM positively. Some Indian startups are at an advanced stage of R&D and are considering applying for regulatory approvals. The FSSAI also formed a working group on cultivated meat (called Working Group on Cultured Meat) in 2020 with regulatory and scientific experts to understand the possible regulatory pathways for cultivated meat in India. GFI India shared information with and presented to the Working Group on the scientific developments, market status, and regulatory status of cultivated meat in other countries and recommended a regulatory roadmap for India. The findings of the Working Group have not been publicly shared yet.