Regulatory Framework for Functional Foods: A Comparative Overview of FSSAI and EFSA
Functional foods are designed to support bodily functions and help lower the risk of chronic diseases, extending beyond basic nutritional content. Functional includes whole foods, fortified products or foods with active ingredients like probiotics, prebiotics, antioxidants or omega-3 fatty acid. Functional foods exist globally in different legal constructs governed by different legal regimes depending on jurisdiction. In this paper I will reflect on the regulation of functional foods in India under FSSAI and in the European Union with EFSA. [1]
Functional Foods Defined
Functional foods are formally categorized by the Food Safety and Standards Authority of India (FSSAI) under its regulatory framework. Safety and Standards Act (2006) defines functional foods under the Food Safety and Standards Act, 2006. Functional foods provide additional health benefits that could reduce controlling certain diseases but are designed to be different from conventional foods through their bioactive components and targeted physiological effects (FSSAI, 2021). [2]
3. Functional Food Examples
Commonly recognized types of functional foods include:
- Fish (sources of omega-3s)
- Whole grains and unsalted nuts
- Fruits and vegetables
- Probiotic foods (e.g., yogurt)
- Foods with added prebiotics, antioxidants, or phytosterols
These components are of benefit to health via modulation of the gut microbiome, reduction in oxidative stress, or improvement in lipid profiles (Konstantinidi & Koutelidakis, 2019).
Regulatory framework: FSSAI (India)
Legal framework
In India, functional foods are regulated under:
- In India, Section 22 of the Food Safety and Standards Act, 2006, governs the regulation of functional foods.
- FSSAI’s 2021 Compendium of Nutraceutical Regulations.
Functional food classifications
FSSAI sets out eight functional food categories:
- Health supplements
- Nutraceuticals
- Foods for special dietary use (FSDU)
- Foods for special medical purposes (FSMP)
- Specialty foods with botanicals
- Probiotic foods
- Prebiotic foods
- Novel foods
Labelling & claims
4.3 Labelling & claims
FSSAI established strict regulations regarding labelling and health claims which include:
Mandatory labelling of ingredients and function The direct or implied claim of a disease is strictly forbidden:
- Example: You cannot say “cures diabetes”
- You also cannot imply a disease claim using symbols or images (e.g. ECG graphs, organs)
- If the claim is qualified, it must have scientific evidence to support it. Evidence can come from human trials, literature reviews, or traditional usage (FSSAI, 2021) [3] [4]
Regulatory Framework: EFSA (European Union)
Legal Structure
The EFSA evaluates functional foods under:
- Regulation (EC) No 1924/2006 on nutrition and health claims
- Regulation (EU) 2015/2283 on novel foods
The EFSA provides a scientific opinion to the European Commission and member states, who ultimately authorize or reject health claims based on the EFSA’s findings.
Health Claim Assessment
The EFSA assesses health claims based on:
- Scientific substantiation (e.g., randomized controlled trials)
- Dose-response assessments
- Nutrient bioavailability and safety assessments
The EFSA distinguishes between:
- Structure-function claims (e.g., “supports bone health”)
- Disease risk reduction claims (e.g., “reduces risk of cardiovascular disease”)
EFSA Scientific Panels
The EFSA has specialized panels, such as:
- NDA Panel (Nutrition, Dietetic Products, and Allergies)
- ANS Panel (Additives and Nutrient Sources)
- FAF Panel (Food Additives and Flavourings)
Each panel is intended to evaluate functional food ingredients with domain-specific expertise.
Transparency and Access
The EFSA has an Open EFSA portal allowing public access to risk assessments, expert review assessments, and claims still being assessed by EFSA, in the interest of transparency and accountability. [5]
Conclusion
Functional foods are playing an increasing role in preventive health and nutrition. In India, the FSSAI has provided specific guidance on classification, labelling, and evidence. Within the European Union, the EFSA exclusively handles the scientific review of health claims and ensures the safety of food ingredients. The differences in approach aside, both regulatory systems aim to require an evidence base for claims, provide consumer protection, and assess risk. Understanding regulations is essential for manufacturers, regulators and researchers developing or assessing functional foods for both domestic and international markets.
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