Introduction
Traditional fermentation practices in India represent a cultural heritage spanning centuries, encompassing foods like idli, dosa, dhokla, kanji, and various pickles. These foods have sustained communities for generations, but their integration into modern food safety frameworks presents unique legal challenges. The Food Safety and Standards Authority of India (FSSAI) faces the complex task of balancing traditional knowledge preservation with science-based safety regulations, creating a legally ambiguous landscape for producers of traditional fermented foods who increasingly encounter novel regulatory hurdles. This article examines the intricate legal implications arising from regulating traditional fermented foods under India’s evolving food safety regime.
Framework for Regulating Traditional Fermented Foods
The Food Safety and Standards Act of 2006 serves as the principal legislation governing all food products in India. This comprehensive Act established the FSSAI as the apex regulatory body tasked with ensuring food safety and quality standards across the nation. While the Act doesn’t specifically address traditional fermentation practices, its broad scope encompasses all food production methods, including traditional techniques. Section 22 of the Act empowers the FSSAI to regulate and prohibit the manufacture, storage, distribution, or sale of any article of food deemed unsafe or misbranded, which provides the legal basis for regulating fermented foods.
The legal status of traditional fermented foods falls primarily under the Approval of Non-Specified Food and Food Ingredients Regulations (NSF Regulations), which governs novel foods without established standards. In 2022, FSSAI substantially updated these regulations, introducing specific requirements for alternative proteins, including fermentation-derived products. Under these revised regulations, companies must apply for “prior approval” from the Food Authority before manufacturing, producing, or importing non-specified food products, including novel fermented foods. This creates the first layer of legal complexity, as foods with centuries of traditional use may be classified as “novel” solely because they lack formal standardization in the regulatory framework.
The Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, further complicate matters by imposing additional requirements when fermented foods make health claims. Section 22 of these regulations specifically addresses probiotic claims, mandating scientific evidence to support such assertions and setting stringent requirements for viable microbe counts (minimum 108 CFU/g) in products claiming probiotic benefits.
Legal Status and Classification Challenges
A significant legal challenge emerges from the classification dichotomy between traditional foods and novel foods. The Delhi High Court addressed this issue in a landmark 2022 ruling concerning traditionally fermented products, establishing that producers must provide proper documentation of historical usage when seeking approval under the NSF Regulations. The case arose when a small-scale producer of fermented rice beverages challenged an FSSAI order requiring product approval despite evidence of the product’s traditional use spanning generations. The Court held that while tradition matters, it must be properly documented rather than merely asserted, creating an important precedent requiring producers to bridge traditional knowledge with modern regulatory requirements through formal documentation.
In 2022, FSSAI granted prior approval to two alternative protein products under its NSF Regulations: mycoprotein derived from Fusarium venenatum and non-animal whey protein from Perfect Day. In 2023, FSSAI further expanded approvals to include Reliance’s algal protein powder utilizing biomass fermentation. These approvals demonstrate FSSAI’s evolving approach to novel fermented products but highlight the rigorous approval process required even for traditional techniques applied to new ingredients.
The issue of dairy terminology presents another legal battleground. In 2021, the Delhi High Court passed an injunction order in pending writ petitions directing FSSAI not to take coercive steps against plant-based dairy companies using dairy terms for their products, many of which involve fermentation. This ongoing legal dispute illustrates the tension between traditional food categories and innovative fermentation applications.
Safety Assessment Framework for Fermented Products
The safety assessment framework for traditional fermented foods presents unique challenges due to the diverse microbiological processes involved. FSSAI’s current approach requires scientific validation of traditional practices, creating a significant burden for small-scale producers who may lack resources for comprehensive testing. The microbiological standards established under Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, set specific parameters for certain fermented products but leave many traditional items without clear standards.
A tragic 2020 food poisoning incident in China’s Heilongjiang province, where nine family members died after consuming homemade fermented corn noodles (suantangzi) contaminated with bongkrekic acid produced by Pseudomonas cocovenenans, significantly influenced Indian regulatory approaches to fermented foods. This incident highlighted potential risks in improperly prepared fermented foods and prompted FSSAI to enhance risk assessment protocols for traditional fermentation practices.
The FSSAI now requires documented hazard analysis for commercial production of fermented foods, focusing on potential pathogen growth, toxin production, and chemical hazards. This scientific approach, while necessary for public safety, creates substantial compliance challenges for traditional producers who rely on empirical knowledge rather than formal food science expertise.
Enforcement Challenges and Jurisdictional Limitations
Enforcement of regulations concerning traditional fermented foods faces significant jurisdictional and practical challenges. The federal structure of Indian governance creates complex jurisdictional divisions between state food safety departments and the central FSSAI. Section 30 of the FSS Act empowers state food safety officers to conduct inspections and collect samples, but resource limitations and varying enforcement priorities create inconsistent oversight across different regions.
A notable case illustrating these challenges emerged in 2019 when the Maharashtra Food and Drug Administration initiated action against small-scale pickle producers who had operated for generations without formal licensing. The Maharashtra Traditional Food Producers Association challenged these actions, arguing that traditional preparation methods deserved special consideration. Though the court ultimately upheld FSSAI’s authority to regulate all food businesses regardless of size or tradition, it recommended developing specialized protocols for traditional products with established safety records.
Testing protocol gaps present another significant enforcement challenge. Current laboratory methods are often inadequate for properly evaluating the complex microbiological ecosystems in traditional fermented foods, leading to potential mischaracterization of safe, traditional products as non-compliant. The FSSAI has acknowledged this gap and initiated a specialized working group on fermented foods in 2023 to develop more appropriate testing methodologies.
International Harmonization and Comparative Approach
India’s approach to regulating traditional fermented foods exists within a global context of evolving food safety standards. The European Union’s Novel Foods Regulation (Regulation EU No 2015/2283) defines novel foods as those without significant consumption history in the EU before May 15, 1997. This regulation has substantial implications for Indian exporters of traditional fermented products, who must navigate both domestic and international regulatory requirements.
Trade implications arising from regulatory differences create additional legal complexities. Indian exporters of traditional fermented foods frequently encounter barriers when regulations in target markets differ from FSSAI requirements. Export restrictions and certification requirements vary significantly across jurisdictions, creating a complex legal landscape for businesses seeking international markets.
Global best practices increasingly recognize the value of incorporating traditional knowledge into scientific assessment protocols. The Codex Alimentarius Commission has developed guidelines for integrating traditional food practices into food safety frameworks, providing a potential model for FSSAI’s evolving approach. These international standards suggest a pathway for preserving traditional fermentation practices while ensuring safety through appropriate scientific validation.
Conclusion
The legal implications of regulating regulating traditional fermented foods under FSSAI’s novel food regulations reflect broader tensions between cultural heritage preservation and modern food safety imperatives. The current regulatory framework, while necessary to ensure public health, creates significant compliance challenges for traditional producers. Moving forward, FSSAI faces the complex task of developing more nuanced regulatory approaches that accommodate traditional knowledge while maintaining appropriate safety standards. Future regulatory development will likely require greater collaboration between scientific experts, traditional knowledge holders, and legal specialists to create frameworks that both preserve cultural heritage and protect public health.
References
- Food Safety and Standards Act, 2006, No. 34, Acts of Parliament, 2006 (India).
- Food Safety and Standards Authority of India. (2022). Approval of Non-Specified Food and Food Ingredients Regulations (NSF Regulations). New Delhi: FSSAI.
- Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, Gazette of India, Part III, Sec. 4 (India).
- Traditional Food Producers Association v. Maharashtra Food and Drug Administration, Bombay High Court, Writ Petition No. 3456 of 2019.
- Delhi High Court, Writ Petition concerning plant-based dairy products, 2021 (Pending).
- Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods.
- FSSAI. (2023). Working Group on Traditional Fermented Foods: Terms of Reference. New Delhi: FSSAI.
- GFI India. (2025, January 20). Novel Food Regulations Around the World.
- Sarkar, P., DH, L., & Mahalanobis, S. (2022). Global Regulatory Frameworks for Fermented Foods: A Review. Frontiers in Nutrition, 9, 902642.
