Regulatory Roadmap for Smart Protein in India

Astha Gaur, Policy Specialist – Regulatory Affairs at Good Food Institute  (GFI) India

Earlier this year, GOOD Meat and UPSIDE Foods’ cell-cultivated chicken was approved for sale in the United States, making the U.S. the second country after Singapore to serve real meat—without the animal—to consumers. With similar submissions of approval applications in Australia (by Vow Food), Switzerland (by Aleph Farms), and the United Kingdom (by Aleph Farms) for cultivated meat, one thing is clear—the appetite and relevance of alternative protein, also called smart protein in India, is on the rise. It is not just cultivated meat that has been gaining momentum, the use of precision fermentation and biomass fermentation technologies to manufacture ingredients to improve the taste and texture of plant-based and cultivated meat, eggs, and dairy has also received regulatory approvals in several countries. Plant-based protein alternatives, on the other hand, have been in the market for a while, and continue to diversify and scale on key parameters through innovative inputs and technologies.

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. Recognising the industry’s potential, the FSSAI  has been considering the need for a regulatory framework for smart protein products in India since 2020, back when the sector was still nascent. Since then, the number of companies has more than doubled and grown to 113, with 97 plant-based companies in the market and over 15 fermentation-derived and cultivated meat companies in the final stages of their R&D, with many near-ready to apply for regulatory approvals. So far, under its Non-Specified Foods regulations, the FSSAI has granted premarket approvals to select companies for mycoprotein and precision fermentation-derived non-animal whey protein. This is in addition to plant-based protein products (classified as proprietary) already present in the market. 

Despite these developments, the path to growth of this sector in India is rife with challenges. Several bottlenecks like the lack of consumer awareness, scarcity of up-to-date domestic safety assessment data, absence of a harmonised regulatory framework for ease of doing business, and an evident communication gap between the smart protein industry and the regulatory body persist.

Here are some focus areas for the FSSAI to boost India’s smart protein market:

Harmonisation of standards with international best practices

Harmonising regulatory standards promotes ease of doing business and trade, and improves consumer understanding by using uniform harmonised nomenclature and labelling. Harmonisation efforts also promote cooperation and knowledge exchange between regulators to build a cohesive food safety environment. 

Effectively communicating relevant safety information about smart proteins to build consumer trust

As India’s food safety and regulatory body, the FSSAI is at the forefront of imparting safety and nutrition information to consumers. This becomes even more important for a sector as nascent and novel as smart protein. Communicating the science behind relevant safety information in an easy-to-understand manner to end consumers will build trust in the sector and help consumers make informed decisions. In the past, the FSSAI campaigns such as Eat Right have been globally appreciated. Another aspect of effective communication is the labelling of products. Allowing correct and informative labelling of smart protein products to communicate accurate sensory information will help consumers understand how to cook, eat, and incorporate smart proteins into their diets. 

Developing multi-agency partnerships to generate and collate safety and risk assessment data

1. Instead of reinventing the wheel, the FSSAI could join forces with other regulatory bodies from other countries to pool resources and generate safety assessment data. The FAO-WHO report on cultivated meat safety aspects has called upon regulators to generate safety assessment data based on the risk assessment framework provided by the FAO/WHO. 
2. Forging a model for interagency partnerships with domestic academic and research institutions and scientific bodies is another way to regularly examine global developments and conduct domestic research that can be shared with the FSSAI’s expert committee when evaluating smart protein applications.
3. Ecosystem capacity building through interagency coordination with bodies such as ITC-FSAN to provide training to food safety and regulatory professionals would permit the FSSAI to tap into existing talent and equip them with the necessary knowledge.

Establishing a scientific panel for smart proteins

 Scientific panels and committees are constituted by the FSSAI to advise on a range of scientific issues, particularly to provide scientific opinions to the FSSAI based on risk and safety assessment. A scientific panel on smart proteins can keep abreast with technological developments and innovations in the smart protein space and analyse the safety data and internationally accepted terminologies to set positive standards and recommend amendments to existing regulatory frameworks.

Establishing a clear engagement model with companies benefits the regulator and the industry by promoting trust and ensuring compliance

1. Early engagement with fermentation-derived and cultivated meat companies intending to apply for pre-market approvals under the Non-Specified Foods Regulations during the development process would enable the regulator to have an oversight on the development process, leading to effective, timely guidance to the companies to ensure regulatory compliance and appropriate data submission to reduce approval timelines.
2. Publishing clear guidance under the Non-Specified Foods Regulations to support smart protein companies (particularly cultivated meat companies) on regulatory requirements would provide clarity to companies on regulatory processes and requirements.
3. Increased transparency by publishing regulatory assessments conducted under the Non-Specified Foods Regulations on approved products (without sharing proprietary information) could help inform the industry and educate the public.

Setting dynamic standards for hybrid smart proteins and accommodating other innovations

 Smart protein technologies are witnessing continuous innovation to help create products that can scale on taste, texture, nutrition, and price. Moreover, products that come to market in the near future might not rely on one individual technology, e.g., a combination of plant-based meat and cultivated meat (referred to as a hybrid product). The FSSAI’s standards and guidance on hybrid products and other future innovations in smart proteins, such as low-cost serum-free media, would be critical to determining the scalability and price parity of the category in India. 

Confronted by similar challenges, regulatory bodies globally are closely scrutinising and, when required, revamping their regulatory frameworks to ensure a go-to-market strategy for sustainable alternatives to conventional animal meat, eggs, and dairy to fulfill the rising consumer demand. For instance, in March 2019, U.S. FDA and USDA-FSIS established a formal agreement to oversee certain cultivated meat products jointly. The UK commissioned a report by Deloitte which made several recommendations for revising the novel food regulatory framework. The report also highlighted the growth of sustainable protein and the need to ensure ease of navigation for novel smart protein applications. More recently, South Korea notified the public consultation process on the draft food standards for alternative protein products. These are just some examples of the global regulatory progress to ensure a clear path to market for smart proteins that India can embrace.

India is uniquely positioned to catalyse the acceleration and go-to-market pathways for these technologies in the developing world.  It can lead the global transition to sustainable food systems while feeding its growing population, augmenting farmers’ income, boosting the economy through exports, and meeting its sustainable development goals. The FSSAI’s regulatory framework will determine how these products continue to enter the Indian market and ultimately define India’s future as a tech-forward sustainable economy leading in smart protein innovation.